Nordic Walking: A new training for frail elderly
Sabrina Figueiredo, B.Sc (Physiotherapist) School of Physical and Occupational Therapy Faculty of Medicine McGill University, Montreal, Quebec, Canada August, 2009
A thesis submitted to the Faculty of Graduate Studies and Research in partial fulfillment of the requirements for the degree of Master of Science in Rehabilitation Science
© Sabrina Figueiredo, 2009
i
ABSTRACT
The elderly are the fastest growing proportion of the world population. Additional increase in longevity, brought about by improved medical technology, will impact significantly on the health care system as, with advancing age comes a variety of acute and chronic health conditions. No matter how fit, advancing age leads to reduction in mobility and physical function, and these changes, affect quality of gait and the capacity for functional and safe ambulation. With the frail elderly, gait impairments are often severe and impact on health and quality of life. Given that improving walking capacity among the elderly is a desired goal, a structured review was conducted - Manuscript 1 - to derive a global estimate for elderly people of the effectiveness of walking training in improving walking related outcomes. The review included publications on MEDLINE, Embase, CINAHL and the Cochrane Library published in English or Portuguese in peer-reviewed journals. Effect sizes of walking programs in these articles were estimated and forest plotted; there was no overall significant effect of walking training on walking distance or gait speed. Some individual studies showed large effect sizes but were underpowered; others showed small effect sizes. Heterogeneity in population and the nature, frequency and intensity of training indicates that this important question is not yet answered and further research is needed. The second manuscript presents the results of a pilot study designed to provide supporting data for a future trial testing a novel walking training strategy - Nordic style pole walking. The purpose of the pilot study was to estimate, for frail elderly persons undergoing physical rehabilitation, the relative efficacy in improving functional walking capacity of two gait training interventions: Nordic Walking and Overground Walking. A randomized controlled trial of 30 participants from two rehabilitations centers of the Greater Montreal Area was carried out: 14 ii
randomized to Nordic Walking and 16 randomized to Overground Walking. Effect sizes for Nordic Walking were moderate for 6MWT (ES = 0.5), large for gait speed (ES = 0.9), and small for fear of falling (E.S = 0.4). Overground Walking showed moderate effects sizes for 6MWT (ES = 0.5) and small ones for gait speed (E.S = 0.4) and fear of falling (E.S = 0.3). After calculating the effectiveness ratio of both interventions, Nordic Walking was 125% more effective in improving gait speed than regular Overground Walking among a frail elderly population. Future trials with large sample sizes are needed to corroborate these results.
iii
ABRÉGÉ
Les personnes âgées forment la tranche de la population mondiale dont la croissance est la plus rapide. De plus, l‟augmentation de l‟espérance de vie grâce aux avancées technologiques en médecine va affecter de façon considérable le système de santé. En effet, le vieillissement de la population implique une diminution des fonctions physiques. Ces diminutions influence la marche et la capacité de se déplacer de façon fonctionnelle et sécuritaire. Une intervention, destinée à améliorer la marche pourrait améliorer la santé et la qualité de vie des personnes âgées fragiles. En premier lieu, une revue structurée de la littérature a été effectuée (Manuscrit 1) afin d‟évaluer l‟efficacité des programmes couramment utilisés afin d‟améliorer la marche chez les personnes âgées. Les banques de données MEDLINE, Embase, CINAHL et Cochrane Library ont permis de trouver des articles anglais ou portugais publiés dans des journaux révisés par les pairs. La taille d‟effet de ces programmes de marche ont étés estimés puis illustrés dans un graphique en arbre. Aucun programme de marche n‟améliorait significativement l‟endurance ou la vitesse de marche. Dans ces études, les programmes avec une taille d‟effet importante avaient une puissance statistique faible et les autres programmes avaient une taille d‟effet réduite. Afin d‟identifier et d‟estimer l‟efficacité d‟interventions destinées à améliorer la marche chez les personnes âgées, d‟autres études sont nécessaires. Le second manuscrit a évalué l‟efficacité de deux interventions destinées à améliorer la capacité fonctionnelle de marche chez les personnes âgées fragiles. Un projet pilote de type essai clinique randomisé a comparé la marche nordique au programme « overground walking ». Trente participants en provenance de deux centres de réadaptation de la région de Montréal ont été aléatoirement placés dans la marche nordique (n=14) et dans le « overground walking » (n= 16). Pour la marche nordique, la taille d‟effet pour le 6MWT était modérée (ES=0.5), celle de vitesse iv
de marche était importante (ES=0.9), et celle pour la peur de chuter était petite (ES=0.4). Pour le « overground walking », la taille d‟effet pour le 6MWT était modéré (ES= 0.5). La taille d‟effet pour la vitesse de marche était petite (E.S. = 0.4) tout comme celle pour la peur de chuter (E.S = 0.3). Les ratios d‟efficacité pour les deux interventions ont démontré qu‟en comparaison avec le « overground walking » la marche nordique est 125% plus efficace pour améliorer la vitesse de marche chez les personnes âgées fragiles. D‟autres études avec de plus large échantillons sont nécessaires pour corroborer ces résultats.
v
ACKNOWLEDGMENTS
I would like to express my deepest gratitude to my supervisor, Dr. Nancy Mayo. Your mentorship and guidance provided me the opportunity to develop strong research skills. Besides, your passion for research and teaching is an inspiration to all of us. I feel honored for being supervised by you. A very special mention goes to Dr. Lois Finch. Thank you so much for your immense support and recommendations. Your research and clinical knowledge were fundamental during this entire process. I would also like to acknowledge Lyne Nadeau. I truly appreciate your assistance with the statistical language and programming. I thank you all the staff from the Geriatric Day Hospital of the Royal Victoria Hospital and from the Richardson Hospital. You always had the door open for me, and this partnership was essential for finalizing the pilot trial. To my family, even far away, you are close. Your belief in me, your encouragements and love made me aim up high, and for that I‟m truly grateful! To my friends and the staff in the Division of Clinical Epidemiology and in the School of Physical and Occupational Therapy, you have all been amazing! Finally, Avi, Chloe, Tal, Lu, Marcia, the Katz family, and all my friends, your love and friendship made this journey much easier. Thank you for making me laugh!
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TABLE OF CONTENTS Abstract………………………………………………………………………………………… I ii Abregé……………………………………………………………………………………….…..
iv
Acknowledgements……………………………………………………………………………..
vi
Table of Contents……………………………………………………………………………….
vii
Index of Tables……………………………………………………………………………..…..
ix
Index of Figures………………………………………………………………………….….…
x
Preface…………………………………………………………………………………..……..
xi
CHAPTER 1: AGING, AGE-RELATED CHANGES, AND FRAILTY ....................................... 1 1.1. Age-related changes: An overview ....................................................................................... 2 1.1.1. Age related changes affecting mobility .......................................................................... 3 1.2. Frailty .................................................................................................................................... 5 1.2.1. Markers of frailty ............................................................................................................ 7 1.2.2. Identifying frailty ............................................................................................................ 7 1.2.3. Measuring frailty............................................................................................................. 8 1.2.4. Consequences of Frailty................................................................................................ 10 1.2.5. Intervening in frailty: prevention and treatment ........................................................... 11 CHAPTER 2: MOBILITY TRAINING IN FRAIL ELDERLY .................................................... 17 2.1. Overground Walking Training ............................................................................................ 19 2.2. Intensive Walking Training ................................................................................................. 21 2.2.1. Treadmill Training ........................................................................................................ 21 2.2.2. Nordic Walking............................................................................................................. 23 2.2.2.1. History of Nordic Walking .................................................................................... 23 2.2.2.2. The Effects of Nordic Walking .............................................................................. 25 2.2.2.2.1. Nordic Walking for People with Health Conditions ....................................... 25 2.2.2.2.2. Fitness Studies on Nordic Walking ................................................................. 27 CHAPTER 3: RATIONALE AND OBJECTIVES ....................................................................... 35 CHAPTER 4: MANUSCRIPT 1 .................................................................................................... 38
vii
4.1. A structured review and meta-analysis on the effectiveness of walking training in the elderly ......................................................................................................................................... 38 Abstract ...................................................................................................................................... 39 Introduction ................................................................................................................................ 40 Methods ...................................................................................................................................... 41 Results ........................................................................................................................................ 42 Discussion .................................................................................................................................. 45 Conclusion .................................................................................................................................. 48 References for Manuscript 1 ...................................................................................................... 53 CHAPTER 5: INTEGRATION OF MANUSCRIPT 1 AND MANUSCRIPT 2 .......................... 55 5.1. Primary research objective of manuscript 1 and 2 .............................................................. 55 5.2. Integration of manuscript 1 and 2 ........................................................................................ 55 CHAPTER 6: MANUSCRIPT 2 .................................................................................................... 56 6.1. Nordic Walking For Frail Elderly: A Randomized Pilot Trial ............................................ 56 Abstract ...................................................................................................................................... 57 Introduction ................................................................................................................................ 59 Methods ...................................................................................................................................... 60 Results ........................................................................................................................................ 67 Discussion .................................................................................................................................. 70 Conclusion .................................................................................................................................. 73 References for Manuscript 2 ...................................................................................................... 80 CHAPTER 7: SUMMARY AND CONCLUSION ....................................................................... 84 REFERENCE LIST........................................................................................................................ 87 APPENDICES ............................................................................................................................. A01 A.1. Conceptual Model ............................................................................................................... A01 A.2. Outcomes Measures ............................................................................................................ A02 A.3. Ethics Approval ................................................................................................................... A21 A.4. Consents Forms ................................................................................................................... A21
viii
INDEX OF TABLES Table
Title
Page
Table 1.1
Disabilities in the Canadian Population by age group and sex
14
Table 2.1
Summary of the randomized control trial on Nordic Walking
33
Table 4.1
Summary of studies on walking capacity of the elderly
50
Table 6.1
Characteristics of study subjects at baseline
75
Table 6.2
Characteristics of the study subjects on all outcomes at baseline
76
(pre) and after intervention (post) and on change from pre to post Table 6.3
Counts of persons sustaining and changing activities after the
77
intervention period Table 6.4
Interventions‟ effects size and the ratio between Nordic Walking
78
(NW) and Overground Walking (OW)
ix
INDEX OF FIGURES
Figures
Title
Page
Figure 1.1
Elderly as a fraction of the Canadian population over time
13
Figure 1.2
Hospital Admissions per 100,000 populations
15
Figure 1.3
Percentage of homecare services use by age group
15
Figure 1.4
Prevalence of frailty among the elders
16
Figure 2.1
Nordic Walking sequence
31
Figure 2.2
Nordic Walking equipment: poles and hand grip
31
Figure 2.3
Nordic Walking and its social myths
32
Figure 4.1
Effects Size of walking training on walking distance
52
Figure 4.2
Effects Size of walking training on gait speed
52
Figure 6.1
Flow of participants through the trial
79
x
PREFACE The first step in writing this manuscript based thesis was the development of a research protocol approved by the School of Physical Therapy and Occupational Therapy in June, 2008. This protocol was written by Sabrina Figueiredo under the guidance of Dr. Nancy Mayo. Then, a literature review was conducted by Sabrina Figueiredo with support from Diana Dawes and Miho Asano. The following steps: obtaining ethics approval, data collection, development of a database and statistical analyses were performed by Sabrina Figueiredo. In addition, Lois Finch was of assistance to obtaining the ethics approval and Lyne Nadeau to statistical difficulties. The thesis was written by Sabrina Figueiredo with extensive editing by Dr. Nancy Mayo and Dr. Lois Finch.
Organization of thesis The two primary objectives of this thesis were to perform a structured review on the effectiveness of walking training in the elderly and to estimate the relative efficacy in improving functional walking capacity of two gait training interventions - Nordic Walking and Overground Walking – among frail elderly. Each objective is independently addressed in two separate manuscripts. These manuscripts will later be submitted to scientific journals for publication. Additional chapters have been included in the thesis in order to follow the regulations of the Graduate and Postdoctoral Studies (GPS). Chapter 1 is an introduction to aging and frailty. It highlights frailty‟s prevalence and its consequences to the health care system. Furthermore, this chapter relates the age-related walking changes and its implication to the functional capacity on the elderly. Additionally, a conceptual model based on the ICF framework was presented as a possible way of intervention.
xi
Chapter 2 reports the walking strategies used nowadays in the rehabilitation environment. It also presents a differentiation between the regular walking training and pole walking, also known as, Nordic Walking. Chapter 3 provides a general rationale for using Nordic Walking as a strategy to improve functional capacity among the elderly. It also outlines the main objectives in the two manuscripts. Chapter 4 consists of the first manuscript. It includes the text, the figures, the tables, and the references. The contents of this manuscript are related to performing a structured review on the effectiveness of walking training on gait speed and walking distance among the elderly. Chapter 5 presents the link or the connection between the conclusion of the first manuscript and the objective of the second manuscript. Chapter 6 consists of the second manuscript. It includes the text, figures, tables and references. This manuscript presents the randomized pilot trial carried out to estimate the relative efficacy of Nordic Walking and Overground Walking training in improving functional walking capacity among a frail elderly population. Originally, the protocol for this trial stipulated training over an 8 week period.
Due to organizational constraints, following subject identification,
consent and evaluation, it was possible to offer training for only 6 weeks prior to discharge. Finally, Chapter 7 summarizes the findings and conclusions of both manuscripts. The appendices contain information that is not normally presented in a manuscript to be submitted for publication. A complete list of appendices is presented in the table of contents.
xii
CHAPTER 1 AGING, AGE-RELATED CHANGES, AND FRAILTY The aging process has important physiological, psychological and societal consequences. Increasing age is characterized by progressive degenerative changes in all bodily tissues and functions. Because aging is the forerunner of a progressive decline in function, the aging process needs to be understood to be modified or delayed. Moreover, the elderly are the fastest growing proportion of the population. In 1997, 6.6% of the world population was over 65 years. This proportion is expected to increase to 10% by 2025, amounting to 800 million seniors worldwide 1. In Canada, this proportion is currently 13.7% and increasing at a rate of 2.7% per year; by 2025, the proportion of people aged over 65 is expected to reach 20% and 33% by the year 2150 2. The growth of the elderly sub-groups can be seen in Figure 1.1. Advances in medical care and new health technology undoubtedly have contributed to the increase in longevity and an increase in the numbers of people surviving into old age. Techniques that range from advanced diagnostics to surgical approaches are more effective and feasible, enhancing treatment for a greater number of people. The changes in health care, including rehabilitation, have led to greater survival rates 2. The subsequent increase in longevity will impact significantly on the health care system, as the rise in survival rates is accompanied by an elevation in morbidity rates 2. Twenty-five percent of the Canadian elderly population have a disability and its prevalence rises with advancing age: 18% in persons 65 to 74 years of age to 53 % in those aged
1
85 and over (Table 1.1) 2. Moreover, approximately 70% of the Canadian health care system budget is attributed to people over 65 years of age. The cost of treating people over the age of 85 is 15 times greater than for those under the age of 55 2. The highest rates of hospital admissions and use of homecare services are found among the elderly (Figure 1.2 and 1.3). In addition this population claims the longest length of stay in acute care hospitals and the greatest rate of institutionalization 2. The aging process is characterized by greater comorbid and chronic conditions 3. Although major age-related changes can be found in all physiological, sensory and cognitive functions many elderly can experience a healthy aging process without significant impairment 4.
1.1. Age-related changes: An overview It is commonly accepted that increasing age is associated with a loss of cognitive and motor functions 5. These losses in cognitive and physical function leads to compromised static and dynamic balance, loss of muscle strength, and diminished vestibular and visual function, which will affect the quality of gait and the capacity for functional and safe ambulation 6 7. Although age-related changes have diverse consequences among the elderly, they are, not a synonym for disability. Many elderly experience what has been termed “healthy aging” 8. Only one fourth of Canadian elderly can expect adverse age-related changes and consequently will present with some level of disability. Despite this, the prevalence of disability and impairments rises with age from 18% in persons 65 to 74 years old to 53% in those aged 85 and over 2. This level of disability is similar to that observed with mobility limitations: with advancing age, mobility restrictions are amplified as are their impact.
2
Based on the magnitude of age-related changes elders can be divided into four groups: middle age includes people from 45 to 64 years old; for people older than 65 years, the following categories are recognized 9: Young-old – aged 65 to 74 years; Middle-old – aged 75 to 84 years; Late-old - aged 85 years and older. The changes related to age are multiplied in the late old age group 9. For this thesis only the age-related changes affecting mobility will be described further. 1.1.1. Age related changes affecting mobility Decreased muscle strength and muscular atrophy are characteristically observed with the aging process and are considered the major causes of loss of mobility, reduced gait speed, increased frailty and increased incidence of falls in the elderly 10. Loss of mobility increases with advancing age and its prevalence ranges from 14% among people with 65 to 74 years to 50% among those older 85 years old 5. Impaired mobility and falls are, after cognitive disorders, the major cause of diminished quality of life. Focusing on age related changes affecting gait, alterations in spatial and temporal parameters have been reported as early as age 60 changes in stride length and cadence
6;12
11
. Several studies have reported significant
. Marigold & Patla, (2008) 13 found that the elderly take
shorter steps, resulting in a reduced stride length. There is also decreased coordination between pelvis and trunk seen as a reduction in pelvic obliquity and rotation in the axial and sagital planes 12
. A reduction in all three planes of these counter-movements impacts on gait stability and
3
results in increased trunk rigidity when walking. A general reduction in range of motion of all lower extremity joints can be observed 14. Functional walking capacity, as indicated by distance walked and gait speed will deteriorate with age. The time taken to walk a well-defined distance increases with age. Among this population a phenomenon called psychomotor slowing is often observed Saltin (1983)
16
and Pollock et al. (1974)
17
15
. Grimby and
reported that in the early part of the seventh decade
the decline in gait speed is accelerated. The distance walked in a set time, as well as capacity to walk on uneven surfaces and up inclines or stairs, were found to decrease with age 6;11;18. Walking distance and gait speed are important for participation in personal, family and societal
roles.
Additionally,
these
two
variables
are
predictors
of
hospitalization,
institutionalization, and perceived and diagnosed health status 19-21. Purser at al., 21 suggested that for every 0.10 m/s reduction in baseline gait speed, when all other variables are constant, overall health status as measured by the SF-36 would decrease by 4.5 units (beta = 4.5 ; 95% CI = 2.8 to 6.1), the physical functioning would decrease 2.1 units (beta = 2.1; 95% CI = 6.9 to 14.8), disability level would increase by 0.6 units (beta = 0.63, CI = 0.53 to 0.73) and the number of visits to rehabilitation centers would increase by 2.0 units (beta = 2.0; CI = 1.4 to 2.5). An inability to ambulate adequately can lead to de-conditioning and a sedentary life style. A sedentary life style has pathological consequences; including muscle atrophy, impaired balance, orthostatic hypotension and decreased cardio respiratory function as well as apathy, depression and cognitive decline
22
. These conditions combine to perpetuate a cycle resulting in
an even greater decrease in mobility. Interestingly, a decrease in walking capacity correlates with an increased fear of falling
11
which is defined as the avoidance or restriction of activities due to the fear of falling. The perpetual concern about falling may prevent someone from performing even usual activities of 4
daily living and from venturing out into the community. The prevalence of fear of falling in the elderly is high: between 12% and 65%, and is greater in women than men. Approximately one out of four elders complains about it. This fear begins commonly after a fall, but is also observed in people without a history of falls 11. Persistent fear of falling among the elderly is in itself associated with slower gait speed, shorter stride length, increased stride width and prolonged double support time
11
. Other studies
also reported that elderly with fear of falling avoided reaching and walking most often. Additionally, fear of falling is a strong predictor of restriction in social activities
23;24
and is
associated with frailty and decreased quality of life 25. However, an association between changes in walking capacity and falls has not been established
25
. This may be because people restrict
their activity rather than risk a fall.
1.2. Frailty With advancing age also comes the onset of disabling health conditions such as cerebrovascular, cardiac and oncologic diseases. The illness and associated disabilities can lead to a complex state recently denominated as frailty 3. Based on the extent of the age-related changes, elders can be further categorized into a pre-frail or a frail state 26. Frailty, originally defined exclusively as a biological syndrome, is characterized by a physiological imbalance between demand imposed and reserve or capacity. Nowadays, although there is a consensus that the concept of frailty should be multidimensional, covering disease, function, cognition, and nutrition, the definition of frailty still lacks consensus. Regardless of this lack of consensus on concepts and definitions, differentiating frailty from comorbidity and disability may improve the understanding of the aging process 27.
5
Many authors provided different definitions for frailty. The most accepted definition is the one provided by Fried
27
, where frailty is considered a multidimensional construct that
implies a vulnerability that emerges when health stressors overwhelm the individual‟s physiological, psychological and social reserves. Against a background of the physiological changes of aging, an acute or chronic health event or condition can precipitate the frailty process or it may be initiated by lack of activity, inadequate nutritional intake, and/or stress. Furthermore, frailty is a state of high vulnerability for adverse health outcomes, including disability, dependency, falls, need for long term care, and mortality 27. Disability is defined as a difficulty or dependency in carrying out activities essential to independent living, including essential roles and tasks needed for self-care and living independently in a home, and desired activities important to one‟s quality of life 28. Comorbidity is the concurrent presence of two or more medically diagnosed diseases in the same individual, with the diagnosis of each contributing disease based on established, widely recognized criteria. In this sense, the concept of comorbidity could be viewed as an interface between the geriatric paradigm of health and the more traditional medical definition of disease 3. Frailty is distinct from, but overlapping with, both comorbidity and disability, as reported by Fried et al. 3. This same study showed that 98% of geriatricians from six academic medical centers across USA and England deemed frailty to be a different concept than disability and 97% of them agreed that frailty encompasses the concurrent presence of more than one characteristic. At least 50 % of those geriatricians cited under nutrition, functional dependence, prolonged bed rest, pressure sores, gait disorders, generalized weakness, aged > 90 years, weight loss, anorexia, fear of falling, dementia, hip fracture, delirium, confusion, decreased frequency on outdoor activities and polypharmacy as characteristics observed in association with frailty 3. 6
1.2.1. Markers of frailty Frailty is considered age related but not age caused. Only 3% to 7% of the early old (65 to 75 years) are classified as frail but the incidence of frailty increases with age, reaching 20% to 26% among people in their 80‟s and 32% among those aged more than 90 years 26. Those characteristics that define a person as frail are referred to as frailty markers and can be divided into three main groups: biological, demographic and social. Biological markers include sarcopenia, decreased strength, decreased balance, lower gait speed, decreased visual acuity, cardiovascular disease, hypertension, diabetes, glucose intolerance, increased c-protein reactive and fibrinogen, and decreased serum levels of insulinlike growth factor-1 26;29. Some of these markers such as glucose intolerance, increased c-protein reactive and fibrinogen, have been shown to activate inflammation and sarcopenia
26
, enhancing
the frailty cycle. Demographic markers include female sex, African-American race, lower educational level, and lower income 4;26;30. Social markers include a decrease in the level of outdoor activities with increased isolation 4;26;30. Some individuals are more susceptible to factors that trigger frailty. Experts speculate that certain environments, medications, age-related changes, diseases and their associated treatments may combine with a particular phenotype to enhance vulnerability to frailty 26. 1.2.2. Identifying frailty The early disabilities distinctive in the frailty process may be clinically undetectable as individuals compensate to achieve a balance between reserve and demands. However, this unstable equilibrium can be easily disrupted by minimal environmental challenges
3;4
. For 7
example, when the loss of reserve reaches an aggregate threshold that leads to serious vulnerability, the syndrome may become detectable by examining clinical, functional, behavioural, and biological markers. To be classified as frail at least three of the following five characteristics need to be identified: Decreased gait speed, Decreased grip strength, Decreased physical activity, Exhaustion, More than 10 pounds or 5% of weight loss in the past year. In the presence of fewer than 3 frailty markers, an individual is considered in the pre-frail stage 3. Not everyone who appears to be frail really is. When frailty is under investigation diseases such as congestive heart failure, polymyalgia rheumatic, Parkinson disease, rheumatoid arthritis, occult malignancy, and infection
26
need to be further investigated. Since these
conditions are treatable they should be identified and treated before classifying a person as frail. 1.2.3. Measuring frailty Due to the lack of agreement and the largely subjective definition, frailty is a concept that cannot be accurately measured. Despite the difficulty in measuring frailty several attempts have resulted in a considerable number of specific indices. Additionally, a variety of generic outcome measures are used in place of specific indices of frailty to assess impairments, activity limitations, participation restriction, personal and environmental barriers, and quality of life. 8
The specific measures of frailty developed thus far are: 1) The Frailty Measure was developed in 1994 by Strawbridge as an initial screening tool to identify frail elderly individuals who warrant extensive functional evaluation. It encompasses physical and nutritive functioning, cognition and sensory problems divided in 16 items 31. 2) The EPIC Assessment System was developed by the European Prototype for Integrated Care to be used primarily with community dwelling elderly. Its 31 items cover health, mental and social functioning, ADL/IADL, well being, and goal setting 32
.
3) The Edmonton Frail Scale is comprised of cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance items. It is a bedside test with 10 items only 33. 4) The Frailty Index was developed by the Canadian Study of Health and Aging research group. It is composed of 70 items including the presence of diseases, ability to perform ADL, physical signs, and laboratory abnormalities. It counts the various deficits and calculates the relative frailty of an individual as a percentage difference from the average score for people of that age 34. 5) The Clinical Frailty Scale is a measure of frailty based on clinical judgment. It classifies elderly patients accordingly to their degree of vulnerability 35. 6) The Functional Autonomy Measurement System (SMAF) aims to measure functional performance in elderly people. Based on the ICF model, it includes 29 items, divided into activities of daily living, mobility, communication mental status and activities of domestic life 36.
9
On investigating the psychometrics properties of these measures, the SMAF, the Edmonton Scale and the Clinical Frailty Scale are reliable, valid, responsive and feasible measures. The Frailty Index has shown good psychometric properties but calculating a frailty index is time-consuming. Studies on the Frailty Measure have shown that this is a measure for elderly in the pre-disability stage. Finally, the psychometric properties of the EPIC Assessment System have not yet been estimated. As previously mentioned, measures that address frailty indicators such as mobility and vitality are commonly used clinically. These measures include: the Mini-Mental State Examination, the Barthel Index 37, the Berg Balance Scale 38, the Timed up & Go 39, the Geriatric Depression Scale (GDS) 40, the Functional Independence Measure (FIM) 41, among many others. Unfortunately, an ultimate consequence of the lack of definition that evolves from frailty is the inconsistency among outcome measures used across scientific communities and health care specialties throughout the world. 1.2.4. Consequences of Frailty Once an individual becomes frail, there is often a rapid, progressive, and self-perpetuating downward spiral toward failure to thrive and death 26. Frailty is a risk factor for rapid functional decline, morbidity, institutionalization, and mortality 42. In a study by Fried et al., (2001) of 5,317 Americans of varying ages from 65 to 101 years, frailty (identified by the presence of at least three characteristics like decreased gait speed, decreased grip strength, decreased physical activity, exhaustion, major weight loss) predicted a 3year greater incidence or progression of disability in both mobility and activities of daily living (ADL‟s), independent of comorbid diseases, health habits, and psychosocial characteristics.
10
Those who were frail were less likely to be socially active 3. Moreover, the authors demonstrated that after adjusting for age, race, sex, smoking and pre-existing comorbidity, patients who were frail had a 1.2 to 2.5 fold increased in their risk for falls, decreased mobility, worsening ADL, institutionalization and death. Additionally, due to the many complications a person normally will face with aging, frailty has a huge impact on the cost to the health system 3. Cacciatore and colleagues (2005) followed 120 persons with chronic heart failure and 1139 without it. After a 12 year follow-up period they reported that mortality among the elderly increased with level of frailty. In this study frail was measured by the presence of three out of five characteristics aforementioned. Being frail was more predictive of long-term mortality in persons with chronic heart failure than those without it 43. 1.2.5. Intervening in frailty: prevention and treatment As there are limited treatments available to decrease frailty, interventions should address the five major components that characterize a person as frail. The ideal treatment for a frail individual should involve a multi-centered team. The initial goal is to optimally manage all medical and or psychiatric illnesses that may be contributing to the frailty process. Physical and occupational therapy interventions should focus on reducing sarcopenia and improving strength, balance and functional walking capacity. Dieticians need to be involved to optimize protein and caloric intake. Apart from disease-specific preventive measures, other strategies should focus on broadening social network to enhance social and cognitive stimulation and prevent isolation 30. Unfortunately interventions to treat and reduce the burden of frailty in the elderly are hampered by our poor understanding of the biological basis of this age-associated syndrome. Clearly, more research is needed in this area 44.
11
A more important and possibly more effective intervention would be to prevent frailty. Studies have shown that interventions initiated in the pre-frail stage can reverse the downward spiral into a full blown frailty syndrome
26
. It is imperative that the populations at risk be
screened in order to identify earlier those in the pre-frailty stage. Studies suggest that the prevention of disabilities is feasible and potentially effective
44
.
Among the possible interventions that could prevent a person from becoming frailty, physical exercise might be the most obvious. Exercise strengthens muscles, reduces levels of inflammatory factors and increases IGF-1 levels. This is important as those two markers can act as percipients in the frailty chain. Moreover, exercising increases the level of anabolic hormones such as testosterone and dehydroepiandrosterone (DHEAS), reducing substantially the circulating levels of inflammatory biomarkers and stimulates the production of free radical scavengers and, in some instances, improves the function of the autonomic system 45. However, as health professionals, we cannot fix what we cannot measure. In order to treat a condition adequately, it is necessary to identify first those who are at risk of being classified as frail. The identification process is extremely important, and must be done at the earliest stage. An early detection will allow initiating preventive interventions, which have been shown to be most effective in this population.
12
Figure 1.1 - Elderly as a Fraction of the Canadian Population over Time
Source: Statistics Canada - Health Canada, 2009 2
13
Table 1.1 - Disabilities in the Canadian Population by age group and sex
Both Sexes
number Total - all ages Total - less than 15 years 0 to 4 years 5 to 14 years
Males
%
3,601,270 12.4
180,930
3.3
%
number
%
1,640,120 11.5
1,961,150
13.3
113,220
4.0
67,710
2.5
26,210
1.6
16,030
1.9
10,180
1.3
154,720
4.0
97,180
4.9
57,530
3.0
1,526,900 13.4
1,893,440
15.7
Total - 15 years and over 3,420,340 14.6 15 to 64 years
number
Females
1,968,490
9.9
921,020
9.4
1,047,470
10.4
15 to 24 years
151,030
3.9
74,500
3.8
76,530
4.0
25 to 44 years
626,610
7.1
288,590
6.6
338,030
7.5
45 to 64 years
1,190,850 16.7
557,940 15.9
632,910
17.5
65 years and over
1,451,840 40.5
605,880 38.5
845,970
42.0
649,180 31.2
296,310 30.2
352,860
32.0
802,670
309,570
493,100
65 to 74 years 75 years and over
53.3
52.1
54.1
Notes: - The Canada total excludes the Yukon, Northwest Territories and Nunavut. - The sum of the values for each category may differ from the total due to rounding.
Source: 2001 - Statistics Canada, Participation and Activity Limitation Survey 2
14
Figure 1.2 - Hospital admissions per 100,000 populations
30000
25000 20000
100,000 habitants
15000 10000 5000 0 < 65
65-74
75-84
> 85
Age groups Source: 2002/2003 Hospital Morbidity Disease 2 Figure 1.3 - Percentage of homecare services use by age group
45 40
35 30
Percentage
25 20 15 10 5 0 < 65
65-74
75-84
> 85
Age groups Source: 2003 Canadian Community Health Survey 2 15
Figure 1.4 - Prevalence of frailty among the elders.
35 30
25 20
Percentage 15 10 5 0 65-74
75-80
>85
Age Groups
Source: 2003 Canadian Community Health Survey 2
16
CHAPTER 2 MOBILITY TRAINING IN FRAIL ELDERLY One of the main markers of frailty is slow gait speed. Functional walking capacity, defined as the walking distance and gait speed needed for everyday activities in and outside home can be greatly limited in elderly people and the likelihood of developing walking disorders limitations increases with the lack of physical stimulation. Walking limitations are also accompanied by an increase in the use of walking aids which further restrict participation particularly in activities outside the home 22. From the clinical perspective decreased gait speed is so prevalent among this population that it is considered one of five indicators of frailty that can be used to identify those most likely to benefit from interventions 3. (The other indicators are decreased grip strength decreased physical activity, exhaustion, and major weight loss.) From the person‟s perspective, elders attending geriatric rehabilitation centers or living in senior‟s residences report that a decrease in mobility was one of the main components of frailty
46
confirming Fried‟s concept. From the
societal perspective, the activity limitations and participation restrictions that arise from mobility limitations impact on morbidity and mortality and lead to frequent use of health care services. As previously mentioned (see Chapter 1), one of the most effective ways to address frailty is with an increase in physical activity and exercise. Currently, the positive effects of exercise in the elderly are well established
47-49
. There is also persuasive evidence for the positive effects of
exercise on neurocognitive function in the elderly. Also, exercising appears to lead to an increase in metabolic proteins and neurotransmissions, revealing it to be a potential intervention for treating and modulating some diseases 47.
17
More specifically, Lazowsky et al. (1999) 48, after randomizing 68 frail elderly individuals into range of motion or functional fitness exercises, reported that mobility and balance significantly improved after performing the later. Additionally King et al., (2000)
49
found that
community based programs focusing on endurance and strengthening exercises resulted in significant functional and improvements in well being among 103 adults aged 65 years and older. Based on previous evidence, rehabilitation programs should aim to improve function by increasing tolerance to walking long distances, gait speed, balance and the capacity to change position safely and quickly. To accomplish these objectives a wide range of rehabilitation interventions are available. These interventions can consist of gait training, walking practice, strengthening of lower limbs muscles, task specific training, stretching and, proprioceptive training, among others. For the purposes of this thesis, it is essential to differentiate gait training from walking training. The MeSH term from Pub Med
50
(the U.S. National Library of Medicine's controlled
vocabulary used for indexing articles for MEDLINE/PubMed) defines gait as the manner or style of walking, while gait training is defined as helping a patient relearn to walk safely and efficiently. The professionals most involved with gait training are rehabilitation specialists, typically physical therapists. They evaluate the abnormalities in a person's gait and employ treatments such as strengthening and balance training to improve stability and function as these pertain to the patient's environment. As part of gait training rehabilitation strategies often incorporate the use of assistive devices such as parallel bars, walkers or canes to promote safe and proficient ambulation. Once again using the MeSH term from Pub Med
50
, walking is defined as an activity in
which the body advances at a slow to moderate pace by moving the feet in a coordinated fashion, one in front of the other. This includes, but is not restricted to, walking for purpose, recreational 18
walking, walking for fitness, and competitive race-walking. The main concern of walking training is to ensure a person can walk for a pre-determined established time, usually a minimum of 20 minutes. Quantity, not quality, is the main objective of walking training. Nevertheless, gait training is important for improving the quality of the walking patterns which are clearly affected with specific pathologies such as stroke or Parkinson‟s disease. However, when concentrating on a geriatric population with limitations in functional walking capacity without specific pathology altering gait, walking training might be a more appropriate strategy to add to other strategies targeting impairments and limitations in other domains. The following is a brief review of the most recognized approaches used by rehabilitation professionals to improve walking capacity regardless of health condition.
2.1. Overground Walking Training Overground walking training is a safe and feasible technique, that can be performed anywhere. It consists of walking at a preferred comfortable speed on an even surface. It is a popular form of moderately intense physical activity for the elderly. A number of studies have been published on the effects of walking training on body composition and aerobic capacity 51;52. In Kubo et al. (2008)
53
a moderate to intense 6-months walking training program or, 15 to 40
minutes, 3 to 4 times a week, resulted in greater muscle thickness and strength, in comparison to a control group instructed not to change their daily or physical activity level. In the rehabilitation scenario, overground walking training is often used as warm-up. Due to environmental and space limitations, most often the client is required to walk back and forth in a corridor for a pre-determined time established by the therapist. With the community-dwelling elderly, walking training can be performed in different locations, indoors or outside. Mall walking is a popular form of exercise for the elderly and 19
combines the capacity to walk for long distances in a safe and weather protected environment
54
.
This variation of the training environment can add interest, motivation and challenge to the exercise. Although walking training is simple and feasible, without the appropriate intensity few, if any, benefits in terms of gait speed or endurance are achieved. A meta-analysis by Lopopolo et al. (2006)
55
reported that high intensity (effort expended by subjects) exercise and high-dosage
(frequency and duration of exercise sessions) intervention had a significant effect on gait speed, whereas there were no effects for moderate- and low-intensity exercise or for low-dosage exercise. In preparation for the study reported in this thesis, the author (SF) and a physical therapy colleague (EL) documented the nature of walking training in two different geriatric rehabilitation settings in the Great Montreal Area. The variety of interventions and the time spent per client were registered over four full days at each setting. This mapping exercise was performed to assist in designing the main trial of this study. Typically, walking training preceded other forms of therapy such as stretching, strengthening and balance exercises. Patients walked in the corridor or in the gymnasium; they received minimal supervision or stimulation from a therapist. The time spent practicing walking varied from 4 to 10 minutes and included the time allotted for any resting. Due to the lack of encouragement most patients rested more than they walked. The inference from this observation was that walking training is only minimally incorporated into geriatric rehabilitation in these two settings. A problem arising from this type of rehabilitation program is related to training specificity. Although the rehabilitation program included elements to improve walking capacity, what is the evidence that strengthening, stretching and balance translate into gains in functional walking? 20
Sipila and Suominen (1995)
56
reported that 18 weeks of strength training induced
hypertrophy in the thigh muscles in 42 elderly women, whereas the effect on walking was insignificant. Similar results were found by Moriello et al. (2009). In a recent study, 60 elders, after 6 weeks of core training, showed greater muscle strength but no improvements in gait speed or walking distance 57. These results combine to indicate that a specific exercise that focuses on improving gait speed and walking distance, with an adequate exercise-dose is needed to achieve positive effects on walking capacity. That is, a more intensive approach is required to produce positive changes in functional capacity.
2.2. Intensive Walking Training 2.2.1. Treadmill Training Treadmill training may be a useful intervention to improve both gait speed and distance. It can be more intense than regular overground walking training as the speed can be controlled. Pohl et al.
58
, when studying 60 ambulatory post-stroke patients, showed the importance of
manipulating the speed of the treadmill to achieve increases in overground gait speed. Ada et al. 59
, after analysing data from 29 ambulatory stroke survivors living in the community more than 6
months post-stroke, proposed that the motion of the treadmill re-enforced the appropriate timing between the lower limbs and ensured that the hips are extended during stance phase. Previous studies in stroke populations demonstrated treadmill training resulted in greater muscle strength
60
, decreased energy expenditure
61
, as well as improved gait speed, walking
capacity and gait symmetry 62. Among twenty-one persons with Parkinson‟s disease, with a mean age of 71 years old, an eight-week exercise program using incremental speed-dependent treadmill training appeared to 21
lead to improved mobility and reduced fear of falling, in comparison to a non-exercise control group of 10 participants 63 . Nevertheless, there is a concern that walking on a treadmill differs from overground walking. Pearce et al, 1983
64
reported that, among 42 middle aged men, age and body mass
significantly (P < 0.05) affected treadmill gait speed, while only age significantly affected floor speed. In addition, significantly greater energy expenditure was found for floor walking in comparison to treadmill walking. At the normal gait speed of 1.3 m/s, the energy cost for the floor was 1.04 ml. kg/1/9 in (P < 0.05) and for the treadmill (age 55-66 years) was 0.58ml/kg/1/ min. These findings indicate that gains achieved by treadmill walking may not translate to gains over ground as floor walking requires greater energy. A study including healthy persons over 65 years of age suggested evident difficulties in adapting to treadmill training among this population
65
. Even after a period of habituation on a
treadmill their gait pattern differs from what was expected as normal for this population. One possible reason for this was the fear experienced by the elderly when they were required to walk on the treadmill. This fear acts as a barrier to training. From the previous studies it is possible to infer that a difference exists between treadmill and overground walking, although the extent of this difference is still debated among researchers. Based on the difficulty in adapting to treadmill, overground walking training seems more appropriate for elders. Another intensive method of training should be considered to replace treadmill training for those who fear it. One method of promoting intensive overground walking training, without using the treadmill, is to use ski poles while walking, a technique called Pole Striding (PS). More recently this nomenclature has been changed to Nordic Walking (NW) 66. 22
2.2.2. Nordic Walking Nordic Walking is a form of walking that uses the muscles of the upper and lower body in a continuous motion movement (Figure 2.1). The poles are similar to those used in cross country skiing but have rubber tips and modified hand grips designed to provide a better platform for the hand during the push phase of poling 66-68 (Figure 2.2.). The walking pattern while using the poles is the same pattern as walking without them. In other words, the reciprocal pattern between upper and lower extremity is maintained. That is when the right hand moves forward, it is accompanied by the left foot. When the arm is finishing its swing phase, the poles, which are at an inclination of approximately 60 degrees, are pushed against the floor. At this point is important to keep the elbow extended, as flexing this joint would interrupt the forces being transmitted from the floor to the body. The hands should constantly be in a "grip-n-go" state with the pole. The pole is griped every time it hits the ground, and then released as it is drawn back behind the body, finishing up with an open hand. As the arms continue to move the poles, the torso and hips are involved in a counter-swinging motion from the lower body 67. When anyone with a balance problem uses the poles, the pole‟s inclination does not need to be backwards. In this case, the person positions the poles in front of their body, aligned with the opposite foot at a 90 degree angle against the floor. As the person using the poles masters this initial technique the poles can be moved progressively backwards 69. The flexible technique of Nordic Walking can be adapted to clients with different needs. 2.2.2.1. History of Nordic Walking The popularity of this intervention is increasing, especially among middle age and elderly people. Nordic Walking has spread from Finland, where 20% of the population are now regular Nordic Walkers, to Germany and Austria, where there are recognized training programmes and
23
systems for accreditation for walking instructors. In the European countries, this technique is suggested for middle age and elderly persons as a fitness program by preventive medicine practitioners
70
. The health benefits are believed to be of such a level that health insurance
companies pay for Nordic Walking classes 71. However, Nordic Walking has a very short history. It was developed in the 70‟s to allow professional cross-country skiers to continue training during summer time. When the first book about Nordic Walking was published the authors did not expect that Nordic Walking would be such a success in the outdoor leisure industry or that it would feature as one of the centrepieces of the 2003 International Tradeshow for Sports (ISPO) 71. The unique feature of this walking technique is the way in which familiar elements such as assisted devices, social and physical skills and the idea of walking for fun are linked together. The idea of walking for fun is already well established, but not with sticks (poles). They have a long history but not one that is associated with fun. Walking sticks are usually associated with frailty and disability 71. Overtime, the Nordic Walking industry started working with physiotherapists to design better walking poles adapted for different populations, with the aim of getting people to use sticks not because they were injured but to prevent themselves from becoming so 71. Although the concept of Nordic Walking is spreading, its full acceptance depends on breaking down a few myths. First, depending on the way people face the use of the poles, some would say that Nordic Walking is for frail people, as they associate the poles with assistive devices. Others see Nordic Walking practitioners as very fit skiers. The second myth is related to the social acceptance: people are afraid of looking silly using the poles, as depicted in the carton (Figure 2.3). In a review by Shove and Pantzar (2009)
71
, many Nordic Walking practitioners
were reported to prefer to start using the walking technique with a group of friends. Only after 24
they were confident in their ability and satisfied with the results of group exercise would they start doing Nordic Walking alone in the streets. One would think that the proven positive effects of Nordic Walking would be enough to overcome personal vanity and a misplaced concerned with appearance. 2.2.2.2. The Effects of Nordic Walking The annotated bibliography on Nordic Walking is comprised of 57 studies from 1992 to 2009. Amongst those studies, 23 are English peer reviewed publications and 34 are from the “grey literature”. The peer reviewed publications were obtained online and the information on the grey literature was obtained from the International Nordic Association via email (
[email protected].) The quantitative studies related to Nordic Walking can be divided into three main fields: 1) health, where the studies include patients with pathological conditions; 2) fitness, in which participants are physically active individuals and 3) sports performance that includes only athletes. Few qualitative studies have estimated the safety or popularity of the technique. 2.2.2.2.1. Nordic Walking for People with Health Conditions Eight studies involved populations with a variety of health conditions. Common findings were that NW improved aerobic and muscular endurance as well as an increase in metabolic markers and health-related life outcomes. Three pre-post studies of Nordic Walking and Health Sciences were annotated in the bibliography. Baatile et al. (2000)
72
, in a pre-post study including 16 elderly males with Parkinson‟s
disease, suggested that Nordic Walking performed three times a week for eight weeks, improved
25
quality of life and perceived functional independence. The time spent doing the walking intervention was not reported. Schottoer et al. (2005)
73
studied 150 patients with orthopaedic problems performing
Nordic Walking for three times a week. Although the length of the program was not reported, 93% of participants reported increased endurance and 63% of them reported an improvement on resistance to stress. Nineteen elderly persons with type 2-diabetes performed Nordic Walking for 90 minutes, twice a week, for one year in a study by Nischwitz et al. (2006)
74
. Results indicated
improvements in all diabetes-related metabolic indicators and significant reduction in daily medication dosage. As summarized in Table 2.1, there have been four randomized controlled trials (RCT): Three involving people with health conditions and one in a sedentary population. Collins et al., (2002;2005)
67 68
;
studied 52 clients with peripheral vascular diseases
performing 30 to 45 minutes of Nordic Walking, three times a week, for 6 months. The researchers concluded that walking with poles effectively improved both the exercise tolerance and perceived quality of life in those patients. In another publication using the same population, 68
the researchers found a significant impact on cardiovascular fitness, improved perception of
health related quality of life, and decreased pain during exertion. Langbein et al. (2002)
75
in
secondary analysis of their data reported a significant improvement in perceived distance walked and perceived gait speed in those performing Nordic Walking. In Sprod et al. (2005)
76
, 12 middle aged women with breast cancer were randomized to
Overground Walking or Nordic Walking, where exercises were performed for 20 minutes, twice a week, for 8 weeks. They found no improvements in the control group. The Nordic Walking group had improved endurance of the upper body. 26
Strombeck et al. (2007) 77 analyzed the data from 21 middle aged women with rheumatic disease, randomized into Nordic Walking or stretching exercises. The duration of intervention was 45 minutes, three times a week, for 12 weeks. Significant improvements in oxygen consumption, fatigue and depression were found among participants in the intervention group. Kukkonen-Harjula et al. (2007)
70
randomized 121 middle aged healthy women to either
40 minutes of Nordic Walking or Brisk Walking, four times per week, for 13 weeks. The only muscular endurance of the quadriceps muscle from participants performing Nordic Walking was the only outcome that showed significant improvement. A study by Walter et al. (1996)
66
, on a population who had undergone coronary artery
bypass surgery (CABG) will be discussed below as there was no training protocol involved. These RCT‟s studies aimed to estimate the effectiveness of a Nordic Walking intervention on physiological and health related quality of life and demonstrated significant effects on these two variables. Unfortunately, the remaining publications were either too underpowered to detect a clinically meaningful change, were biased or were limited in their generalizability through the recruitment of a selected population. Another point elicited in reviewing these RCT‟s is the considerable variation among the interventions used in these trials. 2.2.2.2.2. Fitness Studies on Nordic Walking The studies that estimated the effects of Nordic Walking on fitness were associated with improvements in physiological changes suggesting this type of exercise is potent enough to produce a training effect
66;78-83
. Eight cross-over designs were carried out at one point in time in
order to assess physiological responses.
27
.
In the study by Walter et al. (1996)
66
14 patients with coronary artery diseases who
walked with poles showed greater energy consumption and heart rate compared to walking on the treadmill. Porcari et al. (1997)
78
examined, in 32 healthy individuals the physiological response to
walking with and without poles. The Nordic Walking participants showed, on average, 23 % higher oxygen uptake, 22% higher caloric expenditure and 16 % higher heart rate responses when compared to participants walking on the treadmill. Church et al. 2002 79 analyzed the effects of walking on an outdoor track with and without the poles in 22 young participants. Although perceived exertion did not differ between groups, the participants with the poles had, on average, 20% greater oxygen consumption, caloric expenditure and heart rates. In Wilson et al. (2001)
80
data from 13 healthy adults were analyzed during overground
walking with and without the poles. It was reported that the use of walking poles enabled participants to walk at a faster speed with reduced vertical ground reaction forces, vertical knee joint reaction forces and a reduction in the knee extensor angular impulse and support moment. Thus, people using poles are able to walk faster with less impact on their lower extremity joints. Parker et al. (2002) 84 compared the metabolic responses to graded exercise walking with and without poles in 14 physically active young subjects. No differences were found in the heart rate or metabolic parameters regardless of walking group. Rodgers et al. (1995)
82
examining walking in a healthy group of women (n = 10) found
that oxygen consumption, heart rate and caloric expenditure were significantly greater when walking with the poles than what was observed during Overground Walking. Once again, perceived exertion was not significantly different between the two trainings groups.
28
Schiffers et al. (2006)
83
compared the physiological responses during walking, Nordic
Walking and jogging in fifteen healthy middle-aged women. The authors concluded that submaximal lactate level was lower in Nordic Walking compared to walking or jogging. In Knight and Caldwell (2000)
85
participants walked on an inclined treadmill carrying a
backpack weighting 30% of the participant‟s body mass. Those using the poles showed longer stride length, higher heart rate and lower rating of perceived exertion. A similar study was performed by Jacobson et al. (2000)
81
where 22 healthy volunteers walked with and without
poles caring a backpack of 15 kg. Among heart rate, oxygen consumption, caloric expenditure, and rating of perceived exertion, the latter was the only that showed any significant differences in those walking with poles. The studies related to Nordic Walking and sports performance were not summarized as their results are not applicable to the objectives of this thesis. Few studies were published in European journals in languages other than English 86-88. All these studies used a cross-over design at one point in time and are not reported in here. In summary, benefits of Nordic Walking are seen in greater cardio respiratory workload without an increase in the rate of exertion compared to traditional walking
79
70;78;79
. Subjects are able to exercise longer and harder
. Furthermore, poles provide additional stability and help
reduce the mechanical load on the musculoskeletal system
79;80;88
. This intervention is
inexpensive, does not require complex apparatus or skilled practitioners, which contributes to its increased feasibility 79. Additionally, there have been fewer complaints and side effects reported among Nordic Walking practitioners compared to traditional walking practitioners 72;89. The essential physiological difference between Nordic Walking and traditional walking is the increase in the total exercising muscle mass 68. The reason for this is because the poles act as a force transmitter. The force of the poles against the floor is transmitted to the upper extremity, 29
principally the dorsalis major muscle
72
. Additionally, individuals with good poling technique
may have better blood perfusion of the leg muscles 75. It is possible to infer that Nordic Walking is more intensive than Overground Walking training and appears to be effective in improving physiological responses of the human body. As yet no study on the efficacy of this intervention has addressed the needs of a frail elderly population. Although studies on Nordic Walking show positive results in various populations, the interventions implemented thus far have been lengthy, resembling fitness programs. Nordic Walking has not been adequately studied as a potential rehabilitation technique. The only study 76 using Nordic Walking with a duration shorter than 30 minutes had a small sample size and was unpowered to detect changes. The absence of studies on Nordic Walking as a rehabilitation technique as well as use of Nordic Walking by an elderly frail population and the need for a more intensive and safe way to train walking are the stimuli for further studies on Nordic Walking in an elderly population.
30
Figure 2.1 - Nordic Walking sequence
Mid-phase Initial phase Terminal phase Source: Intraspec.ca at http://intraspec.ca/nordic-walking.php
Figure 2.2 – Nordic Walking equipment: poles and hand grip
Poles
Hand grip
Source: Intraspec.ca at http://intraspec.ca/nordic-walking.php 31
Figure 2.3 - Nordic Walking and its social myths
Source: Garry Parsons Illustrations, 2008
32
Table 2.1- Summary of the Randomized Controlled Trials on Nordic Walking. Author Kukonen 2007 72
Population Harjula, Middle aged women
Intervention IG: Nordic Walking (40 min) 4x/week; 13 weeks CG: Brisk walking (40 min) 4x/w; 13 weeks
Outcome VO2 max Neuromuscular test (one leg squat) Heart Rate Muscle-skeletal pain region Lactate level
Peripheral Vascular G1: n = 13 Disease age = 67 (6) G2: n = 14 age = 64 (8) G3: n = 13 age = 67 (9) G4: n = 12 age = 70 (8)
G1: Nordic Walking + Vit. E 45-60 min; 3x/week; 24 wks G2: Nordic Walking with oil pill 45-60 min; 3x/week; 24 wks G3: Vit. E without exercise
VO2 max Arterial Blood Flow to the leg Perceived distance walked Perceived leg pain HRQOL Perceived gait speed
Collins, 2005 68
Peripheral Vascular IG: n = 27 Disease age = 65 (7) CG: n = 25 age = 68 (8)
IG: Nordic Walking, 30 to 60 minutes; 3x/week; 24 weeks CG: measurement of Ankle Brachial Index (ABI) biweekly
VO2 max Arterial Blood Flow to the legs Exercised time/oxygen uptake HRQOL
Langbein,200275
Peripheral Vascular IG: n = 27 Disease age = 65 (7) CG: n = 25 age = 68 (8)
IG: Nordic Walking, 30 to 60 minutes; 3x/week; 24 weeks CG: Measurement of Ankle Brachial Index (ABI) biweekly
Perceived leg pain Exercise symptoms-free Perceived distance walked Perceived gait speed
IG: Nordic Walking (45 min) 3x/week; 12 weeks CG: Range of motion exercises 3x/week; 12 weeks
VO2 Fatigue Anxiety Depression
Collins, 200267
Strombeck, 2007 Rheumatic Disease 77
Sample Size IG: n = 54 age = 54 ( 3) CG: n= 53 age= 54 ( 3)
IG: n =9 age = 60 (41-65) CG: n = 10 age=56 (42-63)
G4: Oil pill
33
Author Sprod, 200576
Population Breast Cancer
Sample Size IG: n= 6 age = 50 (3)
Intervention Outcome IG: Pole walking (20 min) + Shoulder ROM resistance training (30 min) + Upper body muscular endurance stretching; 2x/week; 8 weeks CG: n= 6 CG: Walking (20 min) + resistance age = 59 (5) training (30 min) + stretching 2x/week; 8 weeks Outcomes in bold are statistically significant. IG = Intervention group; CG = Control group; G1 = group one; G2 = group 2; G3 = group three; G4 = group four; VO2 = oxygen consumption; HRQOL = Health related quality of life; ROM = Range of Motion
34
CHAPTER 3 RATIONALE AND OBJECTIVES
Based on the World Health Organization‟s (WHO) International Classification of Functioning, Disability and Health (ICF), age related impairments among the elderly, poor cardio-respiratory function, muscle weakness, dynamic instability, and fear of falling, would lead to limitations in basic activities, such as walking capacity and performance, which would lead to restrictions in role participation, and affect overall quality of life. This ICF model would suggest that intervening to improve walking capacity would favourable impact on the health and quality of life of frail elders (See appendix A.1 for details on the theoretical model). Nordic Walking provides a number of advantages as a rehabilitation technique. With Nordic Walking, the presence of poles may be seen as exercises aids, which might encourage greater compliance with walking training. Second, the longer stride length and pelvis counter movement provided by Nordic Walking are likely to stimulate a more physiological gait, instead of the shuffling one observed in this population. Third, without a shuffling gait, better heel strike occurs providing the necessary impact to stimulate necessary to bone remodelling. As ground reactions forces are smaller with Nordic Walking, the impact from Nordic Walking will benefit those people with lower extremity joint pathology. Fourth, Nordic walking might strengthen lower extremity and core muscles. Finally, Nordic Walking training might improve cardiorespiratory conditioning in the frail elderly. When all these factors are combined, Nordic Walking has the potential to positively affect elderly mobility, resulting in an improved walking capacity.
35
Additionally, balance and self confidence may increase, leading to a decrease in the fear of falling. Based on positive results in VO2 max seen in various populations after Nordic Walking 9092
, we might expect improvements in walking capacity in an elderly population after a Nordic
Walking intervention. The frail elderly pose other challenges beyond poor walking capacity, such as balance deficits necessitating the use of walking aids. However, using walking aids such as canes or walker is not compatible with good gait patterns as many people adopt a stooped posture when using them. As a consequence, the frail elderly are prone to adopt slow gait and restricted use of walking beyond that required for fulfilling basic needs which will affect negatively their cardiorespiratory condition. In summary, Nordic Walking appears promising as a rehabilitation technique. Studies in the field have been methodologically divergent, especially in the timing, duration and intensity of the interventions. Furthermore, evidence is lacking on the efficacy or effectiveness of Nordic Walking on functional outcomes such as capacity to do distance walking and gait speed. This study will be the first to directly compare Nordic Walking with traditional walking training through a randomized controlled trial among frail elderly. A pilot trial will be performed, before embarking on a large randomized controlled trial of this intervention. The primary objective of this pilot study was to estimate for frail elderly persons the relative efficacy in improving functional walking capacity of two gait training interventions: Nordic Walking and Overground Walking. A secondary objective was to explore the impact of walking training with poles on selfperceived fear of falling.
36
We hypothesize that people receiving Nordic Walking, after 6 weeks of intervention, will show a clinically meaningful improvement in their distance walked in 6 minutes, in gait speed and perceived fear of falling, while persons in the usual walking group will not show meaningful changes.
37
CHAPTER 4: MANUSCRIPT 1 4.1. A structured review and meta-analysis on the effectiveness of walking training in the elderly
Sabrina Figueiredo, B.Sc., PT1; Diana Dawes, M.Sc1.; Miho Asano, M.Sc1.; Nancy E. Mayo, Ph.D1,2,3.
1. 2. 3.
Faculty of Medicine, School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada Division of Clinical Epidemiology, McGill University, Montreal, Quebec, Canada Faculty of Medicine , Department of Geriatrics, McGill University, Montreal, Quebec, Canada
Manuscript prepared for submission to the journal entitled JAGS
Running title: Effectiveness of walking training in the elderly
Name and address for communications and reprint requests: Nancy E. Mayo,, PhD Royal Victoria Hospital Division of Clinical Epidemiology 687 Pine Avenue West, Ross 4.29 Montreal, Quebec, Canada H3A 1A1 Email:
[email protected]
38
Abstract Objectives: To derive a global estimate of the effect of walking training as an strategy to improve distance walked and gait speed in the elderly. Design: A structured review of publications on MEDLINE, Embase, CINAHL and the Cochrane Library using the following terms MeSH walking, MeSH gait, MeSH ambulation, MeSH rehabilitation, MeSH physical endurance, gait velocity, gait speed, six minute walk test, 5MWT, 6MWT. Effects sizes of each intervention were estimated and forest plotted; a metaanalysis estimated and overall effect size. Results: Seven studies were retrieved from an initial pool of 1387 articles. Treadmill and Overground walking were the main strategies used to train walking. No consistency regarding intensity, duration and frequency of training was found. Effectiveness of the walking program on distance walked was small in all studies, ranging from 0.03 to 0.4. The overall effect size for walking distance was 0.26 (95% CI: 0.01 to 0.51). The effectiveness of walking programs for improving gait speed ranged from small effects sizes (ES = - 0.2 to 0.4) to large ones (ES = 2.2 and 3.0) with the latter arising from studies with very small sample sizes. The overall effect size was 0.35 (95% CI: -1.89 to 2.60). Conclusions Among the 7 studies reviewed only two were designed rigorously enough to detect effectiveness. Despite the reported significant statistical differences in two studies, the effects sizes were small for treadmill or regular overground walking training, performed 2-3 times a week for 6 weeks. The overall effect size was non-significant. Keywords: structured review; walking program; walking distance; gait speed; elderly.
39
Introduction The elderly are the fastest growing proportion of the population. In 1997, 6.6% of the world population was over 65 years. This proportion is expected to increase to 10% by 2025, amounting to 800 million seniors worldwide 1 Functional independence is often jeopardized among aged people. Accompanying the physiological aging process are declines in cognitive and physical function which leads to compromised static and dynamic balance, loss of muscle strength, and diminished vestibular and visual function. These in turn will affect the quality of gait and the capacity for functional and safe ambulation2;3. These limitations are more pronounced when associated with other comorbidities and exacerbations of disease 4. Reduced gait speed and incapacity to walk long distances are common impairments among the elderly. Functional walking capacity, reflected by distance walked and gait speed, are related to community mobility and participation in personal, family and societal roles 5. Gait speeds of 1.2 m/s and 0.8m/s are necessary for an individual to safely cross a 4- and 2- lane street 6
. Furthermore, these two variables are predictors of hospitalization, institutionalization, and
perceived and diagnosed health status
5;7;8
. For these reasons improving the walking capacity of
the elderly is a common objective among rehabilitation professionals. As a structured review, the aim of this paper is 1) to derive an estimate of the overall effect of walking training as a strategy to promote improvement in either walking distance or gait speed in the elderly and 2) to provide a comprehensive review of the literature for practitioners, managers and researchers.
40
Methods Data source and extraction The literature published in English or Portuguese between 1997 to 2008 in MEDLINE (using PubMed and Ovid); Embase and the Cochrane library was searched. The terms used in the search were: MeSH walking, MeSH gait, MeSH ambulation, MeSH rehabilitation, MeSH physical endurance, gait velocity, gait speed, six minute walk test, 5MWT, 6MWT. References from the acquired articles were also searched for further relevant studies. The last date for this search was December 25, 2008. Study Selection Inclusion criteria for the analysis were (1) participants 65 years or older; (2) walking training strategy clearly described; (3) gait speed and walking distance as an outcome; (4) clearly reported mean changes and standard deviations of the main outcomes; (5) studies done with humans, randomized controlled trials and systematic reviews. Excluded were studies if (1) it was impossible to extract or calculate the appropriate data from the published results or (2) there was a secondary analysis of results from the same data set. Statistical Analysis Stats Direct Software was used to calculate the effectiveness of each intervention by calculating their effect sizes. This software uses g (modified Glass statistic with pooled sample standard deviation), to calculate an effect size. The formula for calculating g is:
where μi is mean of the intervention group and μc is mean of the control group 9.
41
Random effects model was used due to the heterogeneity of the treatment plans. Estimates of effect sizes and corresponding 95% confidence intervals were derived from the parameters arising from these models. A random effects model make inferences about the parameters of a population of studies that is larger than the set of observed studies. This model assumes that these studies are a random sample of studies that would be done in this area, therefore this model is more generalizable 9.
Results Using the search key-words and limiting the search to studies done in humans, randomized controlled trials and systematic reviews 1387 articles were retrieved. Based on the inclusion criteria, 296 studies were retained. On reviewing the titles 39 publications were selected, from which an in-depth review excluded 32 studies due to age of participants, walking training was not the intervention and absence of a control group. The final analysis included 7 studies summarized in Table 4.1.
[Insert Table 4.1 about here]
Walking Training Among the 7 RCT‟s, there was no consistency as to the content of walking training. Treadmill walking was used in three studies
10-12
and overground walking was used in another
four 13-16. The frequency and intensity varied greatly across studies. The frequency ranged from 1 to 5 times a week and program length from 4 to 48 weeks. The only similarity among the studies was the duration of walking. As expected in all studies, walking was performed for at least 20 minutes, an inclusion criterion of this review. 42
In four of the studies strengthening exercises were also used to improve walking capacity 10;11;13;16
.
In the following analysis only the walking part of the intervention group was outlined and included. Effectiveness of walking training on distance walked Four studies 10;13-15 had distance walked as the outcome of walking training. In each of the studies, the effect size for the intervention group was calculated and summarized. In Holland et al. (2008)
15
30 participants with Interstitial Lung Disease performed
walking training for 30 minutes, twice a week, for 8 weeks. Distance walked significantly improved 35 meters (p 0.2 m/sec. However, the final gait speed of 0.77 m/sec is still slower than the minimum needed for safe community ambulation – 0.8 to 1.2 m/sec 26. One explanation for this increased speed in the Nordic Walking group is that the poles act as a force transmitter, propelling the lower limbs and thus the body forward. This is congruent with the results from Wilson et al., 2001 who found what exactly 8. The person learns this more efficient and powerful way of walking even when not using the poles. As there were significant changes on the Berg Balance Score among subjects in both groups, owing most likely to the interventions carried out as part of the regular rehabilitation program, the change in gait speed cannot be attributed only to change in balance. Although the effectiveness ratio suggests Nordic Walking is 33% more effective in improving fear of falling than Overground Walking, the 95% CI is not significant. The greater efficacy of Nordic Walking on fear of falling could be explained by the association between fear
70
of falling and gait speed and balance ability. As shown by Chamberlin et al., 2005
27
greater fear
of falling is highly associated with slower gait speed. The increase in the Nordic Walking participant‟s gait speed may have directly affected their fear of falling as at the end of the intervention, participants from this group reported less fear of falling. Also, as shown by Hatch el., 2003
28
among 50 elderly, aged 65 to 95 years old, balance explained 75 % of the fear of
falling variance. Therefore balance improvements will affect perceived fear of falling. Nevertheless, the intervention in this study was not long enough to evoke fear of falling improvements. Both groups showed equal improvement in 6MWT. As this study measured walking distance via a sub-maximal text (6MWT) the results in here cannot be comparable with those from a number of other researchers
29-33
who used maximal oxygen consumption to measure the
impact of Nordic walking. In studies from other authors
34-37
changes in walking distance is
similar, or a little superior, to what was obtained here. Nevertheless, in those studies the intervention was longer and more frequent. However, both groups showed a greater than expected change in 6MWT. This is probably due to the enhanced walking practice given to both groups equivalent to an additional 40 minutes per week. In our preparatory work, we noted that walking practice was done for only 4 to 10 minutes during a therapy session. There was little change in HRQL which is not surprising during the short intervention time and that 65% of the sample were inpatients during the study. HRQL is a construct that takes time to realize following gains in mobility 38. Similarly, there was no positive change in activity level. Future research involving a longer intervention, and the opportunity to use the poles for walking and exercise in the community, will address the impact on activity and HRQL.
71
Commentary from the Nordic Walking participants indicated the training was greatly enjoyed as participants felt they were using sport-related equipment rather than disability focused assistive devices such as canes and walkers. Some participants went even further by stating they would now go outside using the poles but would not do so with a walker. This information is consistent with that reported by others 13-15;39. Use of the poles did not increase shoulder or arm pain or disability in the legs which is a positive finding given that many elderly have concomitant arthritis and the use of the arms in the walking exercise could increase shoulder pain. The cost-effectiveness of the Nordic Walking as a rehabilitation strategy is apparent as the cost of a set of Nordic Walking poles is minimal ranging from 40 to 100 dollars based on hand grip, materials, and height options. As some poles are height adjustable, this represents a minimal investment for a rehabilitation unit.
Potential limitations There are a number of limitations to this study, the main one being its pilot nature with a small sample size.
The frequency and duration of the intervention was short and varied
depending on the duration of stay in the rehabilitation setting which was outside the control of the study. It was likely not long enough to have the desired impact. And, finally, without a post intervention follow-up, maintenance of gains is unmeasured. However, the data from this pilot study is more than adequate to motivate a larger randomized clinical trial to estimate the change in each outcome.
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Conclusion Among a mobility challenged frail elderly population, Nordic Walking is 125% more effective in improving gait speed than regular Overground Walking. Moreover Nordic Walking is a safe, feasible and enjoyable technique. Therapists may want use Nordic Walking as a rehabilitation strategy to improve gait speed in the elderly. Although the confidence intervals around these estimates are wide, these findings can be used to design a future trial to estimate the impact of Nordic Walking on gait speed, mobility, community participation and quality of life of persons with or at risk for frailty.
Acknowledgments The authors thank Lyne Nadeau and Susan Scott for their assistance with randomization and data analysis; all the staff from the Geriatric Day Hospital at the Royal Victoria Hospital and from the Richardson Hospital; Harshida Pattel for contributing with the intervention procedure and the data collection.
Conflict of interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
Author Contributions Sabrina Figueiredo was responsible for conducting the trial, analyzing the data and writing the manuscripts. Dr. Lois Finch provided guidance throughout the study and edited the paper. Gloria Mjiali conducted the evaluations. Dr. Sara Ahmed and Dr. Allen Huang provided 73
theoretical input. Dr. Nancy Mayo supervised all aspects of the project, providing procedural guidance, edited and reviewed the paper. Lyne Nadeau provided assistance with database development and management and statistical programming.
Sponsor’s Role Canadian Nordic Walking Association provided 5 pair of poles and two certified training courses. The North American Nordic Association provided 5 pair of poles. The study was supported by MUHC – Geriatric Funding.
74
Graphics Table 6.1 – Characteristics of study subjects at baseline Characteristic
Nordic Walking (n = 14)
Overground Walking (n = 16)
65% / 35%
63% / 37%
78 (± 7) [66-88]
78 (± 7) [65-92]
Women
57%
56%
Previous faller
21%
12%
Walking aid users
93%
94%
0-5
65%
42%
6-10
21%
44%
11-15
14%
6%
>15
0%
6%
Inpatient/Outpatient Rehabilitation Age years mean (± SD)[range]
Number of Comorbidities
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Table 6.2 – Characteristics of the study subjects on all outcomes at baseline (pre) and after intervention (post) and on change from pre to post. Measure
6 Minute Walt Test (m) Pre Post Change 5 Meter Gait Speed (m/s) Pre Post Change Fear of Falling (VAS – 0/100) Pre Post Change Berg Balance Scale (0/56) Pre Post Change LEFS (0-80) Pre Post Change Pain (VAS- 0/100) Pre Post Change EQ5D (VAS – 0/100) Pre Post Change
Nordic Walking (n = 13) Mean SD Range 196 237 41
77 83 48
(120-420) (120-474)
0.56 0.77 0.21
0.23 0.21 0.14
(0.36-1.09) (0.60-1.30)
35 22 -10
30 28 23
(0-80) (0-80)
44 46 2
5 5 6
(38-55) (39-56)
38 36 -2
11 11 9
(18-53) (20-60)
13 17 4
20 20 18
(0-60) (0-50)
60 63 3
12 14 17
(40-85) (35-90)
95%CI
Overground Walking (n = 13) Mean SD Range
95%CI
73 84 54
(120-367) (164-480)
(11,70)
225 266 41
0.20 0.23 0.21
(0.31-0.93) (0.14-0.91)
(0.09,0.3)
0.61 0.69 0.08
24 23 14
(0-70) (0-70)
(-7,21)
24 18 -6
6 5 6
34-56 38-56
(0,4-8)
39 46 7
15 15 6
(18-64) (23-60)
(-6 , 3)
38 39 1
13 18 20
(0-40) (0-50)
(-7 , 15)
15 22 7 65 63 -2
18 15 14
(30-90) (25-80)
(-7 , 13)
(7,75)
(-0.1,0.25)
(-3,15)
(3,10)
(-0.6 , 7)
(-6 , 17)
(-11 , 6)
SD = Standard Deviation; LEFS = Lower Extremity Functional Scale; VAS = Visual Analogue Scale; EQ-5D = Euroqol-5D.
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Table 6.3 - Counts of persons sustaining and changing activities after the intervention period
Activity Intensity
Nordic Walking
Overground Walking
AD
p
AD
BC
P
BC
Easy
12 0 1 0
0.3
10 0
03
0.08
Moderate
40
0.005
50
08
0.005
Hard
11 0 1 1
1.0
90
04
0.04
08
Columns A and D indicate the number of persons who sustained the same level of activity; A participated both pre and post; D did not participate neither pre nor post. Column B indicates the number of persons participating post but not pre (improvement) and C pre but not post (deterioration).
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Table 6.4 – Interventions‟ effects size and the ratio between Nordic Walking (NW) and Overground Walking (OW) Measure
Effect Size of
Effect Size of
Ratio
Nordic Walking
Overground Walking
NW/OW
Six-minute walk test (m)
0.5
0.5
1
Comfortable gait speed (s)
0.9
0.4
2.25
Fear of Falling (VAS – 0/100)
0.4
0.3
1.33
Berg Balance Scale (0/56)
0.4
1.1
0.4
0
0
0
Pain (VAS – 0/100)
0.2
0.5
0.4
EQ-5D (VAS – 0/100)
0.2
0.1
2
LEFS (0/80)
Nordic Walking = NW; Overground Walking = OW; LEFS = Lower Extremity Functional Scale; VAS = Visual Analogue Scale; EQ5D = Euroqol-5D
78
Figure 6.1 – Flow of participants through the trial
Assessed for eligibility (n = 39) Excluded
(n = 6) Eligible patients (n = 33) Refused (n = 3; 10%) Randomized (n = 30)
Allocated to Nordic Walking (n = 14) Outpatients (n = 5) Inpatients (n = 9)
Allocated to Overground Walking (n = 16) Outpatients (n = 6) Inpatients (n = 10)
Discontinued intervention (n = 1) 1 got worse
Discontinued Intervention (n = 3) 2 got worse 1 passed away
Analysed (n = 13) Missing data (n = 1)
Analysed (n = 13) Missing data (n = 3)
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(23) Berg K, Wood-Dauphinee S, Williams JI. The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke. Scand J Rehabil Med 1995;27:27-36. (24) Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health 1992;83 Suppl 2:S7-11. (25) Belle GvaDCM. Sample size as a function of coefficient of variation and ratio of means. The American Statistician 1993;47. (26) Langlois JA, Keyl PM, Guralnik JM, Foley DJ, Marottoli RA, Wallace RB. Characteristics of older pedestrians who have difficulty crossing the street. Am J Public Health 1997;87:393-397. (27) Chamberlin ME, Fulwider BD, Sanders SL, Medeiros JM. Does fear of falling influence spatial and temporal gait parameters in elderly persons beyond changes associated with normal aging? J Gerontol A Biol Sci Med Sci 2005;60:1163-1167. (28) Hatch J, Gill-Body KM, Portney LG. Determinants of balance confidence in communitydwelling elderly people. Phys Ther 2003;83:1072-1079. (29) Blocker WP, Jr. Maintaining functional independence by mobilizing the aged. Geriatrics 1992;47:42, 48-50, 53. (30) Pollock ML, Miller HS, Jr., Wilmore J. Physiological characteristics of champion American track athletes 40 to 75 years of age. J Gerontol 1974;29:645-649. (31) Pope A, Tarlov A. Disability in America: Toward a National Agenda for Prevention. 1991. Washington, DC, National Academy Press.
(32) Ahmed N, Mandel R, Fain MJ. Frailty: an emerging geriatric syndrome. Am J Med 2007;120:748-753. (33) Klein BE, Klein R, Knudtson MD, Lee KE. Frailty, morbidity and survival. Arch Gerontol Geriatr 2005;41:141-149.
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(34) Mangione KK, Craik RL, Tomlinson SS, Palombaro KM. Can elderly patients who have had a hip fracture perform moderate- to high-intensity exercise at home? Phys Ther 2005;85:727-739. (35) Salbach NM, Mayo NE, Wood-Dauphinee S, Hanley JA, Richards CL, Cote R. A taskorientated intervention enhances walking distance and speed in the first year post stroke: a randomized controlled trial. Clin Rehabil 2004;18:509-519. (36) Moffet H, Collet JP, Shapiro SH, Paradis G, Marquis F, Roy L. Effectiveness of intensive rehabilitation on functional ability and quality of life after first total knee arthroplasty: A single-blind randomized controlled trial. Arch Phys Med Rehabil 2004;85:546-556. (37) Holland AE, Hill CJ, Conron M, Munro P, McDonald CF. Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. Thorax 2008;63:549-554. (38) Mayo NE, Wood-Dauphinee S, Cote R et al. There's no place like home : an evaluation of early supported discharge for stroke. Stroke 2000;31:1016-1023. (39) Shove E, Pantzar M. Consumers, Producers and Practices: Understanding the invention and reinvention of Nordic Walking. Journal of Consumer Culture 2005;5:43-64.
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CHAPTER 7 SUMMARY AND CONCLUSION Lately, the elderly population has received a great deal of attention in terms of research and clinical care, mainly because it comprises a large part of the world population, and, because this portion of the population is increasing at a considerable rate, compared with the other ages groups. Moreover, the aging process is marked by many age-related changes resulting in impairments of body functions, activity limitations and participation restrictions. When the delicate equilibrium of the body is unbalanced, the health and environmental stressors exceed the person‟s reserve and frailty ensues. Frail persons are characterized by decreased gait speed, decreased grip strength, decreased physical activity, more exhaustion, and more than a 10 pound or 5% of weight loss in the previous year 3. Rehabilitation professionals are best suited to intervene favorably in many of the frailty indicators, particularly to improve walking capacity. In Chapter 4, manuscript 1 entitled “A structured review and meta-analysis on the effectiveness of walking training in the elderly” indicates that there is a lack of rehabilitation interventions able to promote gains in walking capacity in the elderly. Seven randomized trials showed small effects sizes with confidence intervals that included the null value. The two studies which demonstrated larger effects sizes had flaws in their study design namely small samples sizes and unusually small variation. The results from these studies provided the incentive to find an intervention that could be used in the rehabilitation environment and would be able to produce important gains in walking distance and speed.
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Given the scant literature and inconsistency in the existing interventions to address walking limitations among the elderly, a pilot study was designed to estimate the relative efficacy of two interventions: Nordic Walking and Overground Walking. The reason for choosing these two interventions was because walking is a common and safe technique, practiced by everyone, and it is required for daily life as well as a form of exercise and recreation. Although Nordic Walking resembles walking, it is more intense as it also uses the upper limbs. It also has less of a disability image and more of a fitness image. Nordic Walking has not been studied as a rehabilitation strategy, indicating that many questions about this technique need to be answered. An in-depth review of these two techniques was provided in Chapter 2. In Chapter 6, manuscript 2 “Nordic Walking for Frail Elders: A Randomized Pilot Trial” is the first study to directly compare Nordic Walking with Overground Walking, and their respective effects in walking capacity in frail elderly. The trial was a single-blinded, randomized, pilot trial equivalent to a Phase II trial where safety and efficacy were estimated. The results from this trial proved to be optimistic as Nordic Walking, for a frail elderly population, was 125% more effective in improving gait speed than regular Overground Walking. Moreover, Nordic Walking was as effective as Overground Walking in improving walking distance. Other positive aspect of Nordic Walking was that participants enjoyed it and it was a pain free intervention. In this trial the relative efficacy of both interventions was reported, rather than the mean differences of each outcome. This approach was chosen, due to the small sample size, but yet appropriate for this kind of trial. An adequately powered, parallel-group, randomized clinical trial will be designed based on these results.
85
From these preliminary results is possible to infer that adequate walking training strategies for the elderly, based on scientific evidence, with proven results are needed. The main focus for designing this trial was not to design a walking training that would address all the problems related to walking disabilities, but to provide evidence for a single strategy that is easy to adopt and would produce small but worthwhile gains in gait speed or walking distance. This walking training strategy would then be added to the other strategies therapists use to enhance walking and gait quality. Nordic Walking combined with other proven strategies should provide therapists with the necessary “pieces” to plan an intervention and design a complete evidence-based walking program. Therefore, future work is encouraged. As with any study, this project has limitations that must be considered when examining the results. In the first manuscript only one abstractor performed the review. This may have had an impact on the final selection of articles. Additionally, studies other than English and Portuguese might have been excluded. In the second manuscript, the sample size was small and there is no follow-up assessment, which prevents verifying the maintenance of the effectiveness of each intervention.
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(47) Kramer AF, Erickson KI, Colcombe SJ. Exercise, cognition, and the aging brain. J Appl Physiol 2006;101:1237-1242. (48) Lazowski DA, Ecclestone NA, Myers AM et al. A randomized outcome evaluation of group exercise programs in long-term care institutions. J Gerontol A Biol Sci Med Sci 1999;54:M621-M628. (49) King AC, Pruitt LA, Phillips W, Oka R, Rodenburg A, Haskell WL. Comparative effects of two physical activity programs on measured and perceived physical functioning and other health-related quality of life outcomes in older adults. J Gerontol A Biol Sci Med Sci 2000;55:M74-M83. (50) PubMed. 2009. Online Source.
(51) Hardman AE, Hudson A. Brisk walking and serum lipid and lipoprotein variables in previously sedentary women--effect of 12 weeks of regular brisk walking followed by 12 weeks of detraining. Br J Sports Med 1994;28:261-266. (52) Murphy MH, Hardman AE. Training effects of short and long bouts of brisk walking in sedentary women. Med Sci Sports Exerc 1998;30:152-157. (53) Kubo K, Ishida Y, Suzuki S et al. Effects of 6 months of walking training on lower limb muscle and tendon in elderly. Scand J Med Sci Sports 2008;18:31-39. (54) Travis SS, Duncan HH, McAuley WJ. Mall walking. An effective mental health intervention for older adults. J Psychosoc Nurs Ment Health Serv 1996;34:36-38. (55) Lopopolo RB, Greco M, Sullivan D, Craik RL, Mangione KK. Effect of therapeutic exercise on gait speed in community-dwelling elderly people: a meta-analysis. Phys Ther 2006;86:520-540. (56) Sipila S, Suominen H. Effects of strength and endurance training on thigh and leg muscle mass and composition in elderly women. J Appl Physiol 1995;78:334-340. (57) Moriello C, Mayo N. 2009. Personal Communication.
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(58) Pohl M, Mehrholz J, Ritschel C, Ruckriem S. Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. Stroke 2002;33:553-558. (59) Ada L, Dean CM, Hall JM, Bampton J, Crompton S. A treadmill and overground walking program improves walking in persons residing in the community after stroke: a placebo-controlled, randomized trial. Arch Phys Med Rehabil 2003;84:1486-1491. (60) Smith GV, Silver KH, Goldberg AP, Macko RF. "Task-oriented" exercise improves hamstring strength and spastic reflexes in chronic stroke patients. Stroke 1999;30:21122118. (61) Macko RF, Smith GV, Dobrovolny CL, Sorkin JD, Goldberg AP, Silver KH. Treadmill training improves fitness reserve in chronic stroke patients. Arch Phys Med Rehabil 2001;82:879-884. (62) Van Peppen RP, Kwakkel G, Wood-Dauphinee S, Hendriks HJ, Van der Wees PJ, Dekker J. The impact of physical therapy on functional outcomes after stroke: what's the evidence? Clin Rehabil 2004;18:833-862. (63) Cakit BD, Saracoglu M, Genc H, Erdem HR, Inan L. The effects of incremental speeddependent treadmill training on postural instability and fear of falling in Parkinson's disease. Clin Rehabil 2007;21:698-705. (64) Pearce ME, Cunningham DA, Donner AP, Rechnitzer PA, Fullerton GM, Howard JH. Energy cost of treadmill and floor walking at self-selected paces. Eur J Appl Physiol Occup Physiol 1983;52:115-119. (65) Wass E, Taylor NF, Matsas A. Familiarisation to treadmill walking in unimpaired older people. Gait Posture 2005;21:72-79. (66) Walter PR, Porcari JP, Brice G, Terry L. Acute responses to using walking poles in patients with coronary artery disease. J Cardiopulm Rehabil 1996;16:245-250. (67) Collins EG, Edwin LW, Orebaugh C et al. PoleStriding exercise and vitamin E for management of peripheral vascular disease. Med Sci Sports Exerc 2003;35:384-393.
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(68) Collins E, Langbein, WE, Orebaugh C, Bammert C, Hansom K et al. Cardiovascular Trainning effect associated with polestriding exercise in patients with arterial disease. Journal of Cardiovascular Nursing 20 (3), 107-115. 2005.
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(70) Kukkonen-Harjula K, Hiilloskorpi H, Manttari A et al. Self-guided brisk walking training with or without poles: a randomized-controlled trial in middle-aged women. Scand J Med Sci Sports 2007;17:316-323. (71) Shove E, Pantzar M. Consumers, Producers and Practices: Understanding the invention and reinvention of Nordic Walking. Journal of Consumer Culture 2005;5:43-64. (72) Baatile J, Langbein WE, Weaver F, Maloney C, Jost MB. Effect of exercise on perceived quality of life of individuals with Parkinson's disease. J Rehabil Res Dev 2000;37:529-534. (73) Schottoer M, Kuhn W, Frey A. Nordic Walking - eine moderne alltagsaugliche form der pravention? [abstract]Schottoer M, Kuhn W, Frey A. Phys Rehab Kur Med 2005;15 (74) Nischwitz M, Meier GR, Dieterle Ceal. Nordic Walking bei Patienten mit diabetes mellitus typ 2. [abstract]Nischwitz M, Meier GR, Dieterle Ceal. Diabelogie und Stoffwechsel 2006;1 (75) Langbein WE, Collins EG, Orebaugh C et al. Increasing exercise tolerance of persons limited by claudication pain using polestriding. J Vasc Surg 2002;35:887-893. (76) Sprod LK, Drum SN, Bentz AT, Carter SD, Schneider CM. The effects of walking poles on shoulder function in breast cancer survivors. Integr Cancer Ther 2005;4:287293. (77) Strombeck BE, Theander E, Jacobsson LT. Effects of exercise on aerobic capacity and fatigue in women with primary Sjogren's syndrome. Rheumatology (Oxford) 2007;46:868-871.
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(78) Porcari JP, Hendrickson TL, Walter PR, Terry L, Walsko G. The physiological responses to walking with and without Power Poles on treadmill exercise. Res Q Exerc Sport 1997;68:161-166. (79) Church TS, Earnest CP, Morss GM. Field testing of physiological responses associated with Nordic Walking. Res Q Exerc Sport 2002;73:296-300. (80) Willson J, Torry MR, Decker MJ, Kernozek T, Steadman JR. Effects of walking poles on lower extremity gait mechanics. Med Sci Sports Exerc 2001;33:142-147. (81) Jacobson BH, Wright T, Dugan B. Load carriage energy expenditure with and without hiking poles during inclined walking. Int J Sports Med 2000;21:356-359. (82) Rodgers CD, VanHeest JL, Schachter CL. Energy expenditure during submaximal walking with Exerstriders. Med Sci Sports Exerc 1995;27:607-611. (83) Schiffer T, Knicker A, Hoffman U, Harwig B, Hollmann W, Struder HK. Physiological responses to nordic walking, walking and jogging. Eur J Appl Physiol 2006;98:56-61. (84) Parker L, Wacker P, Andrews N. Metabolic resopnses to graded exercise walking with and without poles. Med Sci Sports and Exerc 2002;34:S295. (85) Knight CA, Caldwell GE. Muscular and metabolic costs of uphill backpacking: are hiking poles beneficial? Med Sci Sports Exerc 2000;32:2093-2101. (86) Ripatti T. Effect of Nordic Walking training program on cardiovascular fitness. [abstract]Ripatti T. Sportatrspezifische Leistungsfahigkeit Deutsche Sporthochschule Koln 2002; (87) Manttari A, Hannola H, Laukkanen R et al. Cardiorespiratory and musculoskeletal responses of walking with and without poles in field conditions in middle-aged women. [abstract]Manttari A, Hannola H, Laukkanen R et al. 9th Annual Congress of the European College of Sport Science 2004;157 (88) Kleindienst FI, Michel KJ, Schwarz J, Krabbe B. [Comparison of kinematic and kinetic parameters between the locomotion patterns in nordic walking, walking and running]. Sportverletz Sportschaden 2006;20:25-30.
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(89) Morsø L, Hartvigsen J, Puggaard L, Manniche C. Nordic Walking and chronic low back pain: design of a randomized clinical trial [abstract]Morsø L, Hartvigsen J, Puggaard L, Manniche C. BMC Musculoskeletal Disorders 2006;77 (90) Brooks D, Finch E, Mayo NE, Stratford PW. Physical rehabilitation outcome measures. A guide to enhanced clinical decision making. 2nd edition ed. . Lippincott Williams & Wilkins, 2002, 2009. (91) Ingle L, Goode K, Rigby AS, Cleland JG, Clark AL. Predicting peak oxygen uptake from 6-min walk test performance in male patients with left ventricular systolic dysfunction. Eur J Heart Fail 2006;8:198-202. (92) Maldonado-Martin S, Brubaker PH, Kaminsky LA, Moore JB, Stewart KP, Kitzman DW. The relationship of a 6-min walk to VO(2 peak) and VT in older heart failure patients. Med Sci Sports Exerc 2006;38:1047-1053.
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APPENDICES A.1- Conceptual model
Ageing
•Shorter Stride length •Decreased pelvis counter movements •Muscle weakness •Static and dynamic instability •Fear of falling
Nordic Walking
Walking limitation
Shopping Attending social events
Personal factors
A01
A.2 – Outcomes measures
A02
Nordic Walking Measurements (English) Evaluation ___Initial
___ 3 weeks Follow Up
___ 8 weeks Follow Up
__________________________________________________________________ 1. Socio Demographic Information 2. Berg Balance Scale 3. Fear of Falling - VAS 4. CHAMPS – Short version 5. LEFS – Lower Extremity functional Scale 6. Pain – VAS 7. EuroQol-5D 8. Five Meter Walk Test 9. Six Minute Walk Test
Subject Name:________________________________________ Setting:_____________________________________________ Days attending setting:_________________________________ Date (DD/MM/YY):______________________________________ Evaluator:___________________________________________
A03
SOCIO-DEMOGRAPHIC AND HEALTH-RELATED INFORMATION _______________________________________________________________________________________ Patient Gender (1) male_______ (2) female________ Patient date of birth: dd/mm/yyyy _____/_______/______
Age:
Past Medical History: _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________
Medications/dosage: _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ ______________________________ _______________________________ _______________________________ _______________________________ _______________________________
_______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ ______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________
_______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ _______________________________ .
A04
SOCIO-DEMOGRAPHIC AND HEALTH-RELATED INFORMATION _______________________________________________________________________________________
Height:__________________
Weight*:________________________ *(Date when was taken):________________ DD/MM/YY
What is the average amount of caffeine (COFFE, BLACK TEA, SOFT DRINKS WITH CAFFEINE) intake per day? (a) None (b) One cup per day (c) 2 to 4 cups per day (d) More than 4 cups per day
Have you fallen in the past month? (1) yes_______ (2)No_________ If yes, how many times? _______________ Where?______________________________________________
+At the present moment, do you use any type of walking aids? (1) yes_______ (2)No_________ If yes, what type?__________________________
Since when?___________________________________
Where:__________________________________________________________________________________
A05
BERG BALANCE SCALE _______________________________________________________________________________________ In most items, the subject is asked to maintain a given position for a specific time. Progressively more points are deducted if the time or distance requirements are not met, if the subject's performance warrants supervision, or if the subject touches an external support or receives assistance from the examiner. Subjects should understand that they must maintain their balance while attempting the tasks. The choices of which leg to stand on or how far to reach are left to the subject. Poor judgement will adversely influence the performance and the scoring.
Equipment required for testing are a stopwatch or watch with a second hand, and a ruler or other indicator of 5, 12 and 25 centimetres. Chairs used during testing should be of reasonable height. Either a step or a stool (of average step height) may be used for item 12.
1. Sitting to standing Instructions: Please stand up. Try not to use your hands for support. ( ) 4
able to stand without using hands and stabilize independently
( ) 3
able to stand independently using hands
( ) 2
able to stand using hands after several tries
( ) 1
needs minimal aid to stand or to stabilize
( ) 0
needs moderate or maximal assist to stand
2. Standing unsupported Instructions: Please stand for 2 minutes without holding. ( ) 4
able to stand safely 2 minutes
( ) 3
able to stand 2 minutes with supervision
( ) 2
able to stand 30 seconds unsupported
( ) 1
needs several tries to stand 30 seconds unsupported
( ) 0
unable to stand 30 seconds unassisted
If a subject is able to stand 2 minutes unsupported, score full points for sitting unsupported. Proceed to item 4.
A06
BERG BALANCE SCALE 3. Sitting with back unsupported but feet supported on floor or on a stool Instructions: Please sit with arms folded for 2 minutes. ( ) 4
able to sit safely and securely 2 minutes
( ) 3
able to sit 2 minutes under supervision
( ) 2
able to sit 30 seconds
( ) 1
able to sit 10 seconds
( ) 0
unable to sit without support 10 seconds
4. Standing to sitting Instructions: Please sit down. ( ) 4
sits safely with minimal use of hands
( ) 3
controls descent by using hands
( ) 2
uses back of legs against chair to control descent
( ) 1
sits independently but has uncontrolled descent
( ) 0
needs assistance to sit
5. Transfers Instructions: Arrange chair(s) for a pivot transfer. Ask subject to transfer one way toward a seat with armrests and one way toward a seat without armrests. You may use two chairs (one with and one without armrests) or a bed and a chair. ( ) 4
able to transfer safely with minor use of hands
( ) 3
able to transfer safely definite need of hands
( ) 2
able to transfer with verbal cueing and/or supervision
( ) 1
needs one person to assist
( ) 0
needs two people to assist or supervision to be safe
A07
BERG BALANCE SCALE _______________________________________________________________________________________ 6. Standing unsupported with eyes closed Instructions: Please close your eyes and stand still for 10 seconds. ( ) 4
able to stand 10 seconds safely
( ) 3
able to stand 10 seconds with supervision
( ) 2
able to stand 3 seconds
( ) 1
unable to keep eyes closed 3 seconds but stays steady
( ) 0
needs help to keep from falling
7. Standing unsupported with feet together Instructions: Place your feet together and stand 1 minute without holding. ( ) 4
able to place feet together independently and stand safely 1 minute
( ) 3
able to place feet together independently and stand for 1 minute with supervision
( ) 2
able to place feet together independently but unable to hold for 30 seconds
( ) 1
needs help to attain position but able to stand 15 seconds feet together
( ) 0
needs help to attain position and unable to hold for 15 seconds
8. Reaching forward with outstretched arm while standing Instructions: Lift arm to 90 degrees. Stretch out your fingers and reach forward as far as you can. Examiner places a ruler at end of fingertips when arm is at 90 degrees. Fingers should not touch the ruler while reaching forward. The recorded measure is the distance forward that the fingers reach while the subject is in the most forward lean position. When possible, ask subject to use both arms when reaching to avoid rotation of the trunk. ( ) 4
can reach forward confidently > 25 cm (10 inches)
( ) 3
can reach forward > 12 cm safely (5 inches)
( ) 2
can reach forward > 5 cm safely (2 inches)
( ) 1
reaches forward but needs supervision
( ) 0
loses balance while trying/requires external support
A08
BERG BALANCE SCALE _______________________________________________________________________________________ 9. Pick up object from the floor from a standing position Instructions: Pick up the shoe/slipper which is placed in front of your feet. ( ) 4
able to pick up slipper safely and easily
( ) 3
able to pick up slipper but needs supervision
( ) 2 unable to pick up but reaches 2-5 cm (1-2 inches) from slipper and keeps balance independently
( ) 1
unable to pick up and needs supervision while trying
( ) 0
unable to try/needs assist to keep from losing balance or falling
10. Turning to look behind left and right shoulders while standing Instructions: Turn to look directly behind you over your left shoulder. Repeat to the right. Examiner may pick an object to look at directly behind the subject to encourage a better twist turn. ( ) 4
looks behind from both sides and weight shifts well
( ) 3
looks behind one side only other side shows less weight shift
( ) 2
turns sideways only but maintains balance
( ) 1
needs supervision when turning
( ) 0
needs assist to keep from losing balance or falling
11. Turn 360 degrees Instructions: Turn completely around in a full circle. Pause, then turn a full circle in the other direction. ( ) 4
able to turn 360 degrees safely in 4 seconds or less
( ) 3
able to turn 360 degrees safely one side only in 4 seconds or less
( ) 2
able to turn 360 degrees safely but slowly
( ) 1
needs close supervision or verbal cueing
( ) 0
needs assistance while turning
12. Placing alternative foot on step or stool while standing unsupported Instructions: Place each foot alternately on the step/stool. Continue until each foot has touched the step/stool four times. ( ) 4
able to stand independently and safely and complete 8 steps in 20 seconds
( ) 3
able to stand independently and complete 8 steps in > 20 seconds
( ) 2
able to complete 4 steps without aid with supervision
( ) 1
able to complete > 2 steps needs minimal assist
( ) 0
needs assistance to keep from falling/unable to try
A09
BERG BALANCE SCALE _______________________________________________________________________________________ 13. Standing unsupported one foot in front Instructions: (Demonstrate to subject) Place one foot directly in front of the other. If you feel that you cannot place your foot directly in front, try to step far enough ahead that the heel of your forward foot is ahead of the toes of the other foot. To score 3 points, the length of the step should exceed the length of the other foot and the width of the stance should approximate the subject's normal stride width. ( ) 4
able to place foot tandem independently and hold 30 seconds
( ) 3
able to place foot ahead of other independently and hold 30 seconds
( ) 2
able to take small step independently and hold 30 seconds
( ) 1
needs help to step but can hold 15 seconds
( ) 0
loses balance while stepping or standing
14. Standing on one leg Instructions: Stand on one leg as long as you can without holding. The patient needs to get into the position without using their hands ( ) 4
able to lift leg independently and hold > 10 seconds
( ) 3
able to lift leg independently and hold 5 - 10 seconds
( ) 2
able to lift leg independently and hold = or > 3 seconds
( ) 1
tried to lift leg unable to hold 3 seconds but remains standing independently
( ) 0
unable to try or needs assist to prevent fall.
TOTAL SCORE (Maximum = 56): _____
A10
FEAR OF FALLING (FF) - VAS _______________________________________________________________________________________
To help people say how much fear of falling they have, we have drawn a scale (rather like a thermometer) on which the least far of falling is marked by 0 and the worst fear of falling you can imagine is marked by 100.
Worst imaginable
fear of falling 100
We would like you to indicate on this scale how well or bad is your fear of falling today, in your opinion.
90
80
70
Your own FF level today
60
50
40
30
20
10
0
No FF
A11
CHAMPS – SHORT VERSION _______________________________________________________________________________________ INSTRUCTIONS
If the person DID the activity in the past 4 weeks:
Step #1
Record the activity in the box.
Step #2
Ask about how many TIMES a week the person usually does it put the number on the line
Step #3
write down how many TOTAL HOURS in a typical week he/she did the activity.
Here is an example of how Mrs. Jones would answer: Mrs. Jones usually visits her friends Maria and Olga twice a week. She usually spends one hour on Monday with Maria and two hours on Wednesday with Olga. Therefore, the total hours a week that she visits with friends is 3 hours a week. In a typical week during the past 4 weeks, did you… Visit with friends or family (other How
many
than those you live TOTAL hours with)?
Less 1 hour
≥9
than 1-2½
3-4½
5-6½
7-8½
a week did you
How usually do it? many TIMES a YES
week?_____ List below the activities the person did over the last FOUR WEEKS using the prior CHAMPS interview answers This Includes 1. Work: 2. Volunteering: 3. Church: 4. Sports: 5. Exercise: 6.
Handicrafts:
7. Hobbies: 8. Housework: (LAUNDRY, COOKING, CLEANING, ETC) 9. Visiting 10. also computer, reading watching TV
A12
CHAMPS – SHORT VERSION _______________________________________________________________________________________ List the activities below that the person did typical week during the past 2 weeks as in the CHAMPS
In a typical week during the past 2 weeks, did How many TOTAL hours a week did you usually do it? you… Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
Activity________________
Less than 1 hour,
How many TIMES a week?_____
5-6½
1-2½
7-8½ 1-2½
7-8½ 1-2½
7-8½ 1-2½
7-8½ 1-2½
7-8½ 1-2½
7-8½ 1-2½
7-8½ 1-2½
7-8½ 1-2½
7-8½ 1-2½
7-8½
3-4½ ≥9 3-4½ ≥9 3-4½ ≥9 3-4½ ≥9 3-4½ ≥9 3-4½ ≥9 3-4½ ≥9 3-4½ ≥9 3-4½ ≥9 3-4½ ≥9
A13
LOWER EXTREMITY FUNCTIONAL SCALE _______________________________________________________________________________________
We are interested in knowing whether you are having any difficulty at all with the activities listed below because of your lower limb problem for which you are currently seeking attention. Please provide an answer for each activity. Today, do you or would you have any difficulty at all with: (Circle one number on each line) ACTIVITIES
a. Any of your usual work, housework or school activities. b. Your usual hobbies, recreational or sporting activities. c. Getting into or out of the bath. d. Walking between rooms. e. Putting on your shoes or socks. f. Squatting. g. Lifting an object, like a bag of groceries from the floor. h. Performing light activities around your home. 1. Performing heavy activities around your home. j. Getting into or out of a car. k. Walking 2 blocks. 1. Walking a mile. m. Going up or down 10 stairs (about 1 flight of stairs). n. Standing for 1 hour.
Extreme Quite a bit Moderate Difficulty of Difficulty or Unable Difficulty to Perform Activity
A Little No bit of Diffi Difficulty culty
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0 0 0
1 1 1
2 2 2
3 3 3
4 4 4
0
1
2
3
4
0
1
2
3
4
A14
LOWER EXTREMITY FUNCTIONAL SCALE _______________________________________________________________________________________
p. Running on even ground. q. Running on uneven ground. r. Making sharp turns while running fast. s. Hopping. t. Rolling over in bed. Column Totals:
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0 0
1 1
2 2
3 3
4 4
Score: _______/80
A15
PAIN - VAS _______________________________________________________________________________________
To help people say how much pain they have, we have drawn a scale (rather like a thermometer) on which the least pain is marked by 0 and the worst pain you can imagine is marked by 100.
Worst Imaginable pain 100
We would like you to indicate on this scale how good or bad is your pain is today, in your opinion.
90
80
70
Your own pain level today
60
50
40
30
20
10
0
No Pain
A16
EURO-QOL (5D) _______________________________________________________________________________________
Please indicate which statement best describes your own health state today. Do not tick more than one box in each group.
Mobility I have no problems in walking about I have some problems in walking about I am confined to bed
Self-Care I have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself Usual Activities (e.g. work, study, housework, family or leisure activities) I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities
Pain / Discomfort I have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort
Anxiety / Depression I am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed
A17
EURO-QOL (5D) _______________________________________________________________________________________
To help people say how good or bad a health state is, we have drawn a scale (rather like a thermometer) on which the best state you can imagine is marked by 100 and the worst state you can imagine is marked by 0.
Best imaginable health state
100
We would like you to indicate on this scale how good or bad is your own health today, in your opinion. Please do this by drawing a line from the box below to whichever point on the scale indicates how good or bad your current health state is.
90
80
70
60
Your own
50
health state today 40
30
20
10
0
Worst imaginable health state
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GAIT SPEED – 5MWT _______________________________________________________________________________________ Comfortable walking speed is determined over distances of 5. Gait speed is measured in a quiet section of the hospital corridor, of the rehabilitation department, or of the subject‟s home, using tape to mark the distances on the floor. Acceleration and deceleration distances, each of 2 m, are marked. Bright pylons are placed at the outer acceleration lines during testing so that the patient can easily visualize the end of the walk distance. The floor should like the following:
I---2 m---I-----------5 m------------I---2 m---I
Confortable gait speed: You should walk along this line in a comfortable pace. Time spent (seconds): _________________________________________________________ Use of walking aids: Y/N
What type: __________________________________
Maximum gait speed: You should walk along this line as fast as safely as possible. Time spent (seconds): _________________________________________________________ Use of walking aids: Y/N
What type: __________________________________
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SIX MINUTE WALK TEST _______________________________________________________________________________
Instructions: 1. The subject should dress in comfortable clothing and wear supportive footwear. 2. The subject may use his/her usual assistive devices (e.g., walker, AFO, etc.). If the subject is able to perform the test without an assistive device, then allow them to do so. However, be consistent with previous 6-MWT measures. 3. Instructions: “The object of this test is to walk back and forth as far as possible for 6 minutes. You will walk back and forth in this hallway. In case you get out of breath or become exhausted, you are permitted to slow down, to stop, and to rest as necessary. You may lean against the wall while resting but must resume walking as soon as you are able. Remember that the object is to walk AS FAR AS POSSIBLE for 6 minutes, but don’t run or jog.” 4. The pace will be determined by the patient. The physiotherapist should walk slightly behind the patient so as not to pace them. 5. Encouragement must be standardized as it has been shown to increase walking speed.1 Standardized encouragement was given to all subjects in the study conducted by Gibbons et al. Every 30 seconds the subjects were told : “You're doing well, keep up the good work.” 6. Total distance walked and the number and duration of rest periods required are noted
Data: Suppl 02: ______ L 02/min
Acc m use: Y / N
# Rests: ________
Duration of Rests: (1) ___________ (2) ___________ (3) ___________ (4) ___________ Distance Walked: _______metres Average Walking Speed (distance/360 sec): _________ metres/sec.
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A.3 - Ethics approval Ethics approval was obtained in December 15, 2008.
A.4 - Consent forms Subjects will be asked to provide voluntary informed consent and to sign the consent form. The researcher will explain the random nature of group allocation, and that the efficacy of the available training program has not been determined yet. Both groups will receive an active intervention that will be added to their existing program. The 20 minute intervention will not detract from other therapeutic activities. It offers minimal risk. The slight risk for falls will be controlled by the training focused at an individual level. A second person will always be in the laboratory to provide additional security. Neither group is expected to be harmed by having more exercise. All adverse events will be recorded and in case of injury, subjects will be treated as required by medical team. Participants will not be paid to participate in the research project. Although the research team do not expect any subject incurring an expense during the study since they are either resident or transported to the center, those requiring transportation will be reimbursed up to a total of $35.00 per visit.
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Patient Consent Form STUDY TITLE: Nordic Walking for Frail Elderly: A Randomized Pilot Trial INVESTIGATORS: Nancy E. Mayo BSc PT, MSc, PhD. COLLABORATORS: Sara Ahmed, BSc PT, MSc, PhD; Allen Huang, MD; Dr. R Ludman, MD; Ms Nancy Cox, BSc PT; Ms Sabrina Figueiredo, BSc PT, MSc candidate. STUDY COORDINATOR: Ms Sabrina Figueiredo, BSc PT, MSc candidate. SPONSORS: Pete Edwards and The American Nordic www.skiwalking.com; Canadian Nordic Walking Association.
Walking
System,
Introduction In many elderly people functional independence is often jeopardized. The decline in physical function leads to compromised static and dynamic balance, loss of muscle strength, and diminished visual function, which will affect the quality of safe walking. Although there are a wide range of rehabilitation interventions that aim to improve walking capacity, to date, no program has used walking poles as a technique to improve walking capacity in an integrated rehabilitation program. Studies have shown that Nordic Walking can improve fitness without increasing effort. People can then exercise longer without feeling as tired. These studies were only done in a healthy, middle-aged people. The purpose of our study is to see if in an older group of people Nordic Walking can be used to improve walking, more than a regular walking training program. We are a group of researchers from McGill University, McGill University Health Center, and the Richardson Hospital. We are interested in studying the potential benefits of Nordic Walking. If you agree to participate, we will randomly assign you to one of the two groups. The decision on which group you will be in is similar to taking names out of a hat. The two groups are (1) an over ground walking training program and (2) a pole walking training program. No matter which group you are assigned to, you will receive a walking training program. This will consist of walking practice (with or without poles), periods of rest as needed, stretching, and mobility exercises. The walking program will be added to your usual rehabilitation program at either the Geriatric Day Hospital at Royal Victoria Hospital or at the Richardson Hospital. The research intervention will not replace your usual treatment. For 8 weeks, a trained research therapist will guide and supervise you through individual sessions lasting 20 minutes each. There will be 2 sessions per week.
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Benefits We are evaluating the benefits of the two exercise programs. There is no guarantee that you will benefit directly from the program. Throughout the training program you will be monitored by research professionals. In addition, the increase knowledge we gain from the study may help people in the future. Procedures Because you are attending the Geriatric Day Hospital at Royal Victoria Hospital or the Richardson Hospital, we are asking you if you would be interested in participating in this study. Your agreement will involve participation in the following: 1. Twice a week, you will train, either with or without the poles. The sessions last 20 minutes each and consist of walking, stretching and mobility exercises. This will last 8 weeks. You will participate in 16 sessions. A research therapist will closely monitor your exercises and modify them according to your needs and comfort 2. If you are in the group using the poles, a trained research therapist will teach you the proper way to walk with the poles. 3.
A research physiotherapist will assess you, at the Institution you are attending rehabilitation, at admission, and then after 2 and 8 weeks. These tests consist of a 6minute walk test, a gait speed test and simple questionnaires. We will also look at your balance and ask you how you felt about the training.You will need to fill-in questionnaires on fear of falling, lower extremity pain, participation and quality of life. The entire assessment should last approximately one hour.
4.
We would also like to ask you questions about demographic information and access your medical chart regarding concomitant health conditions as well as supporting laboratory and clinical results of other tests you may have done at your Institution.
Risks and Inconveniences There are no serious risks involved in participating in this study. If you feel any discomfort while exercising, we will assist you. If this condition persists, we, the research team, will advise the hospital. There might be a slight possibility of falling during the training, but we will take every precaution to prevent this from happening. In the unlikely event that you become physically ill or injured as a result of participating in this study, necessary medical treatment will be made available to you as usual. The McGill University Health Centre, the MUHC Research Institute, the Richardson Hospital, and the investigator would not be able to offer compensation in the unlikely event of an injury resulting from your participation in this research study. However, you are not giving up any of your legal rights by signing this consent and agreeing to participate to this study.
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Furthermore, the investigator can terminate your participation in the project without your consent, if in his/her opinion it would be harmful for you to continue. We will communicate to you any information or relevant results that may affect your participation. Confidentiality Any personal information you provide (name, address, and health information) as well as any relevant information to this research project that might be collected from your medical file (such as concomitant health conditions including supporting laboratory and clinical data) will be kept strictly confidential. This information will be kept safe in a locked filing cabinet within a secure space in a locked office in the Division of Clinical Epidemiology at Royal Victoria Hospital. We will put all the information into a computer and remove your name and any personal information. Then we will assign your file a number, your name will not be on the forms. The information for the program will be in the form of statistical table and later on summarized into graphs. No information from any individual will be released. The results of this research may be presented at meetings or in publications but your identity will not be disclosed. Your name will not appear in any publication or report from this study. In the future, the information we gather may be used by other researchers to answer additional research questions about elderly and for this reason all data will be kept for 15 years. I agree to allow the data collected from this study to be used for future health research about the elderly, as long as I am not personally identified, and the same conditions concerning confidentiality and storage of data agreed to for the present study are adhered to. Yes No Voluntary Participation and Right to Withdraw Your participation in this project is voluntary. You have the right to leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. Compensation You will not be paid to participate in this research study, but you will be reimbursed for your travel expenses, up to an amount of $35.00 per visit. Contact Information The person in charge of the research project is Dr. Nancy Mayo. The research coordinator is Sabrina Figueiredo, who can be reached at 514-934-1934 ext. 36906. She is available to answer any questions you may have about the study. If you have any questions about your rights as a participant in a research project, you can call the Patient Ombudsman of the Royal Victoria Hospital at 514-934-1934 ext. 35655.
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STUDY TITLE: Nordic Walking for Frail Elderly: A Randomized Pilot Trial INVESTIGATORS: Nancy E. Mayo BSc PT, MSc, PhD. COLLABORATORS: Sara Ahmed, BSc PT, MSc, PhD; Allen Huang, MD; Dr. R Ludman, MD; Ms Nancy Cox, BSc PT; Ms Sabrina Figueiredo, BSc PT, MSc candidate. STUDY COORDINATOR: Ms Sabrina Figueiredo, BSc PT, MSc candidate SPONSORS: Pete Edwards and The American Nordic www.skiwalking.com; Canadian Nordic Walking Association
Walking
System,
Statement of consent I, __________________________ have reviewed the material in the consent form. I have discussed the above information with the researcher and I have had the opportunity to ask further questions. I consent to participate in this study. _________________________________ (Printed) name of participant _________________________________ Signature of participant
_________________________ date of signature
_________________________________ (Printed) name of person reading consent
_________________________________ Signature
_________________________ date of signature
15/12/2009
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Formulaire de consentement TITRE DU PROJET: La marche nordique pour les personnes âgées fragiles: Un projet pilote randomisé. CHERCHEURS: Nancy E. Mayo BSc PT, MSc, PhD. ASSOCIÉS : Sara Ahmed, BSc PT, MSc, PhD; Allen Huang, MD; R Ludman, MD., Nancy Cox, BSc PT, Sabrina Figueiredo, BSc PT, MSc candidate COORDONATRICE: Sabrina Figueiredo, BSc PT, MSc candidate COMMANDITAIRES: Pete Edwards & The American Nordic Walking System www.skiwalking.com Introduction L‟indépendance fonctionnelle de beaucoup de personnes âgées est compromise. La diminution de leur fonction physique au niveau de leur balance statique et dynamique, la diminution de leur force musculaire et leur diminution de leur fonction visuel, ce qui affecte leur qualité de marcher en sécurité. Même s‟il y a plusieurs exercices de réadaptation qui visent à augmenter la mobilité, à ce jour, aucun de ces programmes de réadaptation n‟ont utilisé les bâtons de marche comme outil dans un programme de réadaptation intégré. Des études ont prouvé que la marche nordique peut augmenter la forme physique sans effort supplémentaire. Les personnes peuvent donc s‟exercer plus longtemps sans la sensation de fatigue. Ces études ont toues été réalisé à l‟intérieur d‟une population en santé et d‟âge moyen. L‟objectif de notre étude est d‟examiné pour voir si un groupe de personnes âgées pourraient augmenter leur forme physique en utilisant la marche nordique au lieu de d‟un programme de marche habituel. Nous sommes un groupe de chercheurs de l‟Université McGill, du Centre de Santé de l‟Université McGill et de l‟hôpital Richardson. Nous sommes intéressé a étudié les bénéfices potentiels de la marche nordique. Si vous consentez à y participer, vous serez assigné au hasard à un des deux groupes. Ces deux groupes consistent en (1) un programme de réadaptation sur le sol et (2) un programme de réadaptation avec des bâtons de marche. Que vous soyez dans un groupe ou dans l‟autre, des vous recevrez un programme de d‟exercice. Les séances d‟exercice (avec ou sans pôles) comprennent des étirements, des entraînements à la marche, des exercices de mobilisation et des périodes de repos. Ces exercices seront ajoutés à
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votre thérapie courante à l‟Hôpital de jour en gériatrie de l‟Hôpital Royal Victoria ou de l‟Hôpital Richardson. Notre intervention ne remplacera pas les soins que vous obtenez habituellement. Durant une période de 8 semaines, un(e) thérapeute de la recherche vous guidera et vous supervisera tout au long des sessions d‟entraînement individuelles qui dureront 20 minutes chaque. Il y aura 2 sessions par semaine. Bénéfices Au cours de cette étude, nous comparerons les avantages de ces deux programmes d‟exercices. Il n‟est pas certain que votre entraînement vous apportera des bénéfices. Pour la durée du programme d‟exercice vous aurez un suivi médical complet. De plus, les résultats de cette étude permettront d‟aider d‟autres individus ultérieurement. Déroulement du programme Nous vous invitons à participer à cette étude parce que vous êtes un patient à l‟Hôpital de jour en gériatrie de l‟Hôpital Royal Victoria ou à l‟Hôpital Richardson. Si vous acceptez de participer, voici ce qui vous attend : 5.
Vous participerez à deux sessions de 20 minutes (incluant de la marche, des étirements et des exercices de mobilité) chacune par semaine (avec ou sans pôles) et ce, pendant 8 semaines. Vous participerez à 16 entraînements au total. Le ou la thérapeute de la recherche supervisera attentivement vos sessions et ajustera l‟intensité des exercices selon vos besoins et votre confort.
6.
Si vous êtes choisi dans le groupe avec pôles, une thérapeute de la recherche entraînée à ce programme vous montrera comment utiliser les pôles de façon appropriés.
7.
Lors de votre première, deuxième et huitième semaine, dans votre centre de réhabilitation respective, le ou la thérapeute de la recherche évaluera votre vitesse de marche et votre endurance à marcher pendant six minutes, l‟évaluation « gait speed », ainsi qu‟un questionnaire simple. Vous répondrez également à des questionnaires écrits. Nous évaluerons aussi votre balance physique et nous vous demanderons comment vous vous sentez dans ce programme. Vous répondrez également à des questions sur votre niveau de douleur, votre équilibre, votre peur de tomber, votre participation à vos activités habituelles et sur votre qualité de vie en général. L‟évaluation entière devrait durer environ une heure.
8.
Nous aimerions également vous posez des questions sur vos informations démographiques ou médicales et consulter votre dossier médical, pour savoir information sur votre état de santé et examen physique et résultats de laboratoire que vous pourriez avoir subis à votre hôpital.
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Risque et inconvénients. Vous ne courez pas de risques sérieux en acceptant de participer à cette étude. S‟il arrivait que vous ressentiez quelque inconfort ou douleur qu‟il soit, nous vous apporterons les soins nécessaires. Si ces malaises devaient persister, nous, le groupe de chercheurs, aviserons l‟hôpital immédiatement. Il y a un faible risque de tomber lors des entraînements, cependant nous veillerons à prendre toutes les précautions nécessaires afin d‟éviter une chute. Si jamais, vous deviez être blessé ou avoir des problèmes physiques dû à votre participation à cette étude, les traitements médicaux nécessaires seront disponibles. L‟Université McGill, le Centre de Santé de l‟Université McGill, l‟hôpital Richardson ainsi que les chercheurs ne pourra pas vous offrir une compensation si jamais vous souffrez d‟une blessure dû à votre participation dans l‟étude. Cependant, vous n‟abonner pas vos droits légaux en signant ce formulaire de consentement et en acceptant de participer à cette étude. En outre, le chercheur peut mettre fin à votre participation sans votre consentement, s‟il a des raisons de croire qu‟il serait dangereux pour vous de continuer. Toutes informations ou résultats pouvant affecter votre participation vous sera également transmises. Confidentialité Vos informations personnelles (nom, adresse, information médicale) ou toutes informations nécessaires à cette étude provenant de votre dossier médical (information sur votre état de historique médical, examen physique, résultats de laboratoire), toutes ces informations seront traitées de façon confidentielle. Votre dossier sera identifié par un numéro et seulement le personnel autorisé aura accès aux dossiers. Les dossiers seront gardés dans des filières verrouillées dans un bureau qui lui aussi est verrouillé dans la Division d‟épidémiologie clinique de l‟hôpital Royal Victoria dont l‟accès est sécurisé par un code d‟entrée électronique. Toutes l‟information collectées sera introduites dans un ordinateur, ce faisant, votre information personnel ne sera pas transférée, seulement votre numéro de dossier. Ces données seront utilisées pour préparer des tables et des graphiques statistiques pour tous les participants. Aucune donnée personnelle ne sera publiée de façon individuelle. Les résultats de cette étude pourraient être présentés lors de conférences ou publiés dans des revues scientifiques, mais aucune identification individuelle ne sera diffusée. Ultérieurement, l‟information que nous recueillons pour être utiliser par d‟autres chercheurs pour répondre à des questions additionnelles sur les personnes âgées, pour cette raison, les données seront gardées pendant 15 ans. Je permets que les donnés collectées pour cette étude soient utilisées dans autres études futures sur la santé des personnes âgées, en autant qu‟on ne puisse pas m`identifier personnellement. Les même conditions par rapport à la confidentialité et la conservation des données de cette étude s‟appliqueraient aussi aux autres études futures. Oui
Non
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Participation volontaire et droit de se retirer de l’étude Votre participation à ce projet est entièrement volontaire et vous pouvez décider de vous retirer de l‟étude à n‟importe quel moment. Si vous décidez de ne pas participer à cette étude ou de vous retirer avant la fin, cela n‟affectera pas vos soins de santé. Compensation Vous ne recevrez aucune compensation pour votre participation à l‟étude. Cependant, vous serez remboursé pour vos dépenses de voyagement, un montant maximal de $35.00 par visite.
Personnes ressources La personne en charge du projet de recherche est Dr. Nancy Mayo. Sabrina Figueiredo, la coordonnatrice de l‟étude peut être rejointe au (514) 934-1934 poste 36906. Elle est disponible pour répondre à vos questions concernant l‟étude. Si vous avez des questions concernant vos droits en tant que participant à ce projet d‟étude, vous pouvez parler à l‟ombudsman des patients au (514) 934-1934 poste 35655.
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TITRE DU PROJET: La marche nordique pour les personnes âgées fragiles: Un projet pilote randomisé. CHERCHEURS: Nancy E. Mayo BSc PT, MSc, PhD. ASSOCIÉS : Sara Ahmed, BSc PT, MSc, PhD; Allen Huang, MD; R Ludman, MD., Nancy Cox, BSc PT, Sabrina Figueiredo, BSc PT, MSc candidate COORDONNATRICE: Sabrina Figueiredo, BSc PT, MSc candidate COMMANDITAIRES: Pete Edwards & The American Nordic Walking System www.skiwalking.com
Déclaration du participant Je, ai lu le dépliant d‟informations sur l‟étude. J‟ai discuté de cette information avec l‟équipe de recherche et j‟ai eu l‟occasion de poser des questions. Je consens à prendre part à cette étude.
___________________________________________ Nom du patient (lettres moulées) ___________________________________________ Signature du patient
______________________ date
________________________________________ Nom du témoin (lettres moulées)
___________________________________________ Signature du témoin
______________________ date
15/12/2009
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