Clinical trial NCT03122626: Does a Group, Task-oriented Community-based Exercise Program Improve Everyday Function in People With Stroke?
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Balance
Mobility Limitation
Activities of Daily Living
Keywords: stroke
community-based exercise program
task-oriented exercise
group exercise program
healthcare-recreation partnership
randomized controlled pilot trial
mixed methods
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Heart and Stroke Foundation of Canada
name: University of Western Ontario, Canada
name: Ontario Stroke Network
name: Institute for Clinical Evaluative Sciences
First posted: 2017-04-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2-group randomized controlled trial in which participants are assigned to immediate or delayed participation in a community exercise program
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Subjective Index of Physical and Social Outcome (SIPSO)
timeFrame: Change from baseline to 3 months.
measure: Nottingham Extended Activities of Daily Living (NEADL)
timeFrame: Change from baseline to 3 months.
Secondary outcomes:
measure: Barthel Index
timeFrame: 5 Baseline, 3 months, 6 months, and 12 months
measure: EuroQol five dimensions questionnaire
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Stroke Impact Scale
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Berg Balance Test
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Activities-specific Balance Confidence (ABC) Scale
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: 30-second Timed Sit-to-stand Test
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: 6-Minute Walk Test
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: 10-metre Walk Test
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Life Space Assessment questionnaire
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Canadian Study of Health and Aging-Clinical Frailty Scale
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Trail Making Test
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Geriatric Depression Scale-Short Version
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Occurrence of injurious falls
timeFrame: Monthly, Months 1-12
measure: Number of healthcare services utilized
timeFrame: 12 months
measure: Type of healthcare services utilized
timeFrame: 12 months
measure: Number of homecare services
timeFrame: Monthly, Months 1-12
measure: Type of homecare services
timeFrame: Monthly, Months 1-12
measure: Blood Pressure
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Heart Rate
timeFrame: 0.5 minutes
measure: Mobility aid type
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Mobility aid number
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Stroke characteristic
timeFrame: Baseline
measure: Stroke characteristic date
timeFrame: Baseline
measure: Stroke side
timeFrame: Baseline
measure: Stroke type
timeFrame: Baseline
measure: Sociodemographic data-age
timeFrame: Baseline
measure: Sociodemographic data-sex
timeFrame: Baseline
measure: Height
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Weight
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Sociodemographic data-employment
timeFrame: Baseline
measure: Education level
timeFrame: Baseline
measure: Personal income
timeFrame: Baseline
measure: Charlson Comorbidity Index
timeFrame: Baseline
measure: Co-intervention type
timeFrame: Monthly (1-12 months)
measure: Co-intervention frequency
timeFrame: Monthly (1-12 months)
measure: Caregiver Assistance Scale
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Rand
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Time per week spent caregiving
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Costs report
timeFrame: Bi-weekly (1-3 months)
measure: Intervention fidelity-activity checklist
timeFrame: Bi-weekly (1-3 months)
measure: Intervention feasibility-attendance sheet
timeFrame: Bi-weekly (1-3 months)
measure: PT Evaluation form
timeFrame: Weekly (1-3 months)
measure: Adverse events
timeFrame: Weekly (1-3 months)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto, Department of Physical Therapy
state: Ontario
Study officials:
affiliation: University of Toronto
name: Nancy Salbach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aravind G, Bashir K, Cameron JI, Howe JA, Jaglal SB, Bayley MT, Teasell RW, Moineddin R, Zee J, Wodchis WP, Tee A, Hunter S, Salbach NM. Community-based exercise programs incorporating healthcare-community partnerships to improve function post-stroke: feasibility of a 2-group randomized controlled trial. Pilot Feasibility Stud. 2022 Apr 22;8(1):88. doi: 10.1186/s40814-022-01037-9.