Does a Group, Task-oriented Community-based Exercise Program Improve Everyday Function in People With Stroke?

Study Overview
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Brief Summary
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After a stroke, people find it difficult to perform everyday activities independently, like getting dressed, preparing meals, and shopping, limiting their independence and requiring the assistance of a family member, friend or a home care worker. Losing one's independence can decrease quality of life. Functional exercise classes run by physical therapists where people with stroke practice getting in and out of a chair, stepping, and walking, can improve the ability to balance, walk, and do everyday activities. These classes are not commonly available in community centres, mainly because fitness instructors do not receive training in how to run exercise classes for people with stroke. Therefore there is a need to make these functional exercise programs available in local community centres. The objective of this project is to test procedures for running a large study to see whether people with stroke improve their ability to do everyday activities after participating in functional group exercise classes for 12 weeks in local community centres. If ability to do everyday activities improves, the investigators wish to see if the improvement is still present 3, 6 and 9 months later. Physical therapists at a nearby hospital will teach fitness instructors how to run the exercise class, help out during the classes, and answer questions by email or phone. Before conducting the larger Canada-wide study, it is important to determine the interest in such a program, the acceptability of the evaluations and the costs associated with the program, the degree of improvements resulting from the program, and if fitness instructors are able to run the program as planned. In Toronto, London and Pembroke, Canada, managers at a hospital and a nearby recreation centre have agreed to help run the exercise program. A recruiter will ask people with stroke who can walk and are being discharged home from the hospital whether they can be called about the study. People with stroke and a caregiver who agree to participate in the study will complete four evaluations when they enter the study, and 3, 6, and 12 months later. At each evaluation, people with stroke will perform tests of balance and walking, and complete questionnaires about their mood, participation in valued activities, and quality of life. After the first evaluation, the investigators will use a process like flipping a coin, to see if the person with stroke will begin the exercise program immediately or 12 months later. The investigators will call people each month to ask if a fall occurred. The investigators will interview exercise participants, family members and hospital/recreation staff at the end of the study to ask about the experiences. This project is unique because the program combines the expert knowledge and skills of physical therapists and fitness instructors. The exercise program involves practicing everyday movements, making the exercises easy for fitness instructors and people with stroke to learn. Each exercise has multiple levels of difficulty so the instructor can adapt exercises to how the person is feeling. The exercise program does not require expensive equipment (e.g. chairs, stepping stools) and therefore can be offered in most community centres. Finally, an extensive network of hospitals providing stroke care and community centres run by recreation organizations exists in Canada. Thus, if this program is beneficial, it could easily be made widely available. With the number of Canadians living with the consequences of stroke increasing every year, access to a functional exercise programs in local community centres will improve their ability to function and live independently in the community and reduce the burden on family or caregivers and on the healthcare system.

Official Title
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Increasing Access to Community-based Task-oriented Exercise Programs Through Healthcare-recreation Partnerships to Improve Function Post-stroke: Feasibility of a 2-group Randomized Controlled Trial Protocol

Conditions
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Stroke, Balance, Mobility Limitation, Activities of Daily Living

Intervention / Treatment
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* Behavioral: Together in Movement and Exercise (TIME) Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of stroke recorded in the health record; Age ≥ 18 years; Living at home for at least 3 months; Ability to walk a minimum of 10 metres with or without walking aids without assistance from another person; Ability to follow verbal instructions or demonstrations of the exercises; Ability to speak and read English; and Willingness to obtain medical clearance from a healthcare provider and sign a liability waiver. Exclusion Criteria: Self-reported involvement in another formal exercise or rehabilitation program; Conditions or symptoms preventing participation in exercise (e.g., unstable cardiovascular disease, significant joint pain); Cognitive or behavioural deficits that would prevent cooperation within a group; Self-reported ability to walk more than 20 minutes without a seated rest; and Self-reported ability to manage environmental barriers (curbs, ramps, and stairs) with relative ease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 2-group randomized controlled trial in which participants are assigned to immediate or delayed participation in a community exercise program
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The intervention is a group, task-oriented exercise program involving two 1-hour exercise classes per week for 12 weeks. The class involves a seated warm-up, repetitive, progressive practice of functional balance and mobility tasks, and a seated cool down. The warm-up consists of active range-of-motion exercises, aerobic exercise, leg loading, stretching, and sit-to-stand training. The cool-down involves exercises with an emphasis on stretching and relaxation. Tasks are organized in a 3-station circuit completed by participants grouped by overall ability: Superstation 1: walking, aerobic training, and wall work (standing and reaching, wall push-ups); Superstation 2: standing weight shifts, coordinated with stepping and lunging; and Superstation 3: tap-ups, step-ups, and heel/toe raises, hamstring curls, marching-on-the-spot, and mini-squats. Participants are instructed to be physically active by walking in their neighbourhood, practicing the program exercises, or using the stairs. | Behavioral: Together in Movement and Exercise (TIME) Program<br>* The TIME program is an evidence-based, standardized, progressive, licensed exercise program developed by physical therapists at the Toronto Rehabilitation Institute-University Health Network.<br>|
| No Intervention: Wait-listed Control Group<br>The control group will receive usual care which will be monitored and is expected to consist of provision of a home exercise program and information on community resources according to current best practices. At the end of the study period, participants in the control group will be offered to participate in the 3-month exercise program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Index of Physical and Social Outcome (SIPSO) | 10-item, self-report questionnaire. 2 subscales: physical function (5 items), social function (5 items) | Change from baseline to 3 months. | 
| Nottingham Extended Activities of Daily Living (NEADL) | 22-item, self-report performance of instrumental ADL in 4 categories: mobility, kitchen, domestic, and leisure. | Change from baseline to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index | 10-item, self-report or objective measure to assess level of independence in ability to perform basic activities of daily living | 5 Baseline, 3 months, 6 months, and 12 months | 
| EuroQol five dimensions questionnaire | 5-item, self report questionnaire to assess health utility | Baseline, 3 months, 6 months, and 12 months | 
| Stroke Impact Scale | 59-item, self-report, 8 scales: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, participation. | Baseline, 3 months, 6 months, and 12 months | 
| Berg Balance Test | 14-items, objective measure designed to assess static balance and fall risk in adult populations | Baseline, 3 months, 6 months, and 12 months | 
| Activities-specific Balance Confidence (ABC) Scale | 16-item, self-report; level of confidence in doing activities without losing balance or becoming unsteady | Baseline, 3 months, 6 months, and 12 months | 
| 30-second Timed Sit-to-stand Test | Number of full sit-to-stands as possible in 30 seconds starting from a sitting position in a chair of standard height (43.2 cm) with no arm-rests | Baseline, 3 months, 6 months, and 12 months | 
| 6-Minute Walk Test | Maximum distance walked in 6 minutes (standard encouragement each minute) on a straight 30-metre path. | Baseline, 3 months, 6 months, and 12 months | 
| 10-metre Walk Test | Time taken to walk the middle 10 m of a 14-m walkway at a comfortable and maximum pace | Baseline, 3 months, 6 months, and 12 months | 
| Life Space Assessment questionnaire | 6-item, self-report. Indicate zones of the home, the neighborhood and the community that have been accessed in the past 3 days; the frequency of visit to these places and the use of auxiliary devices/ assistance | Baseline, 3 months, 6 months, and 12 months | 
| Canadian Study of Health and Aging-Clinical Frailty Scale | Indicates level of frailty of an individual based on impairments in mobility, function and self-rated health | Baseline, 3 months, 6 months, and 12 months | 
| Trail Making Test | Trails A consists of paper with circled numbers (from 1-25). Participants connect circles in numerical order as fast as possible. Trails B consists of paper with circled numbers and letters. Participants connect numbers and letters in order, alternating between numbers and letters. | Baseline, 3 months, 6 months, and 12 months | 
| Geriatric Depression Scale-Short Version | 15-item, self-report. Response options are yes or no. Depressive responses are assigned a score of 1 point. Item-level scores are summed to yield a total score that is used to classify the level of depressive symptoms. | Baseline, 3 months, 6 months, and 12 months | 
| Occurrence of injurious falls | Participants are provided monthly falls calendar, coordinator contacts monthly to obtain details of any falls | Monthly, Months 1-12 | 
| Number of healthcare services utilized | Primary care, Outpatient care, Inpatient care, Community care; Data are routinely collected and can be obtained from the Institute of Clinical and Evaluative Sciences (ICES) 6 months following the study end date | 12 months | 
| Type of healthcare services utilized | Primary care, Outpatient care, Inpatient care, Community care; Data are routinely collected and can be obtained from the Institute of Clinical and Evaluative Sciences (ICES) 6 months following the study end date | 12 months | 
| Number of homecare services | Monthly details of services used | Monthly, Months 1-12 | 
| Type of homecare services | Monthly details of services used | Monthly, Months 1-12 | 
| Blood Pressure | Systolic/Diastolic Pressure | Baseline, 3 months, 6 months, and 12 months | 
| Heart Rate | Heart rate | 0.5 minutes | 
| Mobility aid type | Types of mobility aids used | Baseline, 3 months, 6 months, and 12 months | 
| Mobility aid number | Number of mobility aids used | Baseline, 3 months, 6 months, and 12 months | 
| Stroke characteristic | Date, side and type of stroke | Baseline | 
| Stroke characteristic date | Date of stroke | Baseline | 
| Stroke side | Side of brain in which stroke occured | Baseline | 
| Stroke type | The type of stroke | Baseline | 
| Sociodemographic data-age | Age in years | Baseline | 
| Sociodemographic data-sex | Sex | Baseline | 
| Height | Height in meters | Baseline, 3 months, 6 months, and 12 months | 
| Weight | Weight in Kg | Baseline, 3 months, 6 months, and 12 months | 
| Sociodemographic data-employment | Employment Status | Baseline | 
| Education level | Years of education | Baseline | 
| Personal income | Category of personal income | Baseline | 
| Charlson Comorbidity Index | 16-item scale to predict mortality. 8 items are given 1 point each, 8 other receive a score depending on the severity of condition | Baseline | 
| Co-intervention type | Type of co-intervention | Monthly (1-12 months) | 
| Co-intervention frequency | Frequency of co-intervention | Monthly (1-12 months) | 
| Caregiver Assistance Scale | 17-item, caregiver self-report Indicates assistance provided to the care recipient in basic and instrumental ADLs and treatment-related activities | Baseline, 3 months, 6 months, and 12 months | 
| Rand | Emotional well-being and Energy/Fatigue Score, 9-item, self-report; Caregiver's perceived emotional status and energy levels over the past 4 weeks. | Baseline, 3 months, 6 months, and 12 months | 
| Time per week spent caregiving | Time in hours | Baseline, 3 months, 6 months, and 12 months | 
| Costs report | Self-reported costs for implementing one 12-week exercise program will be estimated for; healthcare system: salary of physical therapist train and provide consultation to fitness instructors; recreation provider: salary of fitness instructors and program coordinators, marketing, room booking, overhead, and equipment; and program participant: registration fee, transportation, personal health aides, unpaid caregiver's lost salary | Bi-weekly (1-3 months) | 
| Intervention fidelity-activity checklist | TIME Program activities at Recreation Site-Completed by Fitness Instructors | Bi-weekly (1-3 months) | 
| Intervention feasibility-attendance sheet | TIME Program attendance at Recreation Site-Completed by Fitness Instructors | Bi-weekly (1-3 months) | 
| PT Evaluation form | Evaluation conducted by Physical Therapist healthcare partner regarding the adherence to protocol | Weekly (1-3 months) | 
| Adverse events | Adverse events occurring during the TIME exercise program; completed by fitness instructors | Weekly (1-3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, community-based exercise program, task-oriented exercise, group exercise program, healthcare-recreation partnership, randomized controlled pilot trial, mixed methods