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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Toronto
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Nottingham Extended Activities of Daily Living (NEADL)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Dr. Nancy Salbach
Professor
University of Toronto
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Nottingham Extended Activities of Daily Living (NEADL)
Time Frame: Change from baseline to 3 months.
22-item, self-report performance of instrumental ADL in 4 categories: mobility, kitchen, domestic, and leisure.
Subjective Index of Physical and Social Outcome (SIPSO)
Time Frame: Change from baseline to 3 months.
10-item, self-report questionnaire. 2 subscales: physical function (5 items), social function (5 items)
Secondary Outcomes
- Berg Balance Test(Baseline, 3 months, 6 months, and 12 months)
- Life Space Assessment questionnaire(Baseline, 3 months, 6 months, and 12 months)
- Number of healthcare services utilized(12 months)
- Number of homecare services(Monthly, Months 1-12)
- Stroke Impact Scale(Baseline, 3 months, 6 months, and 12 months)
- Trail Making Test(Baseline, 3 months, 6 months, and 12 months)
- Type of homecare services(Monthly, Months 1-12)
- 10-metre Walk Test(Baseline, 3 months, 6 months, and 12 months)
- Barthel Index(5 Baseline, 3 months, 6 months, and 12 months)
- EuroQol five dimensions questionnaire(Baseline, 3 months, 6 months, and 12 months)
- 30-second Timed Sit-to-stand Test(Baseline, 3 months, 6 months, and 12 months)
- Canadian Study of Health and Aging-Clinical Frailty Scale(Baseline, 3 months, 6 months, and 12 months)
- Stroke type(Baseline)
- Activities-specific Balance Confidence (ABC) Scale(Baseline, 3 months, 6 months, and 12 months)
- Geriatric Depression Scale-Short Version(Baseline, 3 months, 6 months, and 12 months)
- Heart Rate(0.5 minutes)
- Sociodemographic data-age(Baseline)
- Personal income(Baseline)
- Costs report(Bi-weekly (1-3 months))
- Intervention feasibility-attendance sheet(Bi-weekly (1-3 months))
- 6-Minute Walk Test(Baseline, 3 months, 6 months, and 12 months)
- Sociodemographic data-employment(Baseline)
- Intervention fidelity-activity checklist(Bi-weekly (1-3 months))
- Occurrence of injurious falls(Monthly, Months 1-12)
- Type of healthcare services utilized(12 months)
- Blood Pressure(Baseline, 3 months, 6 months, and 12 months)
- Mobility aid number(Baseline, 3 months, 6 months, and 12 months)
- Stroke characteristic date(Baseline)
- Stroke side(Baseline)
- Co-intervention frequency(Monthly (1-12 months))
- Rand(Baseline, 3 months, 6 months, and 12 months)
- Time per week spent caregiving(Baseline, 3 months, 6 months, and 12 months)
- PT Evaluation form(Weekly (1-3 months))
- Adverse events(Weekly (1-3 months))
- Mobility aid type(Baseline, 3 months, 6 months, and 12 months)
- Stroke characteristic(Baseline)
- Sociodemographic data-sex(Baseline)
- Height(Baseline, 3 months, 6 months, and 12 months)
- Weight(Baseline, 3 months, 6 months, and 12 months)
- Education level(Baseline)
- Charlson Comorbidity Index(Baseline)
- Co-intervention type(Monthly (1-12 months))
- Caregiver Assistance Scale(Baseline, 3 months, 6 months, and 12 months)