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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03122626
Enrollment
33
Registered
2017-04-21
Start date
2017-02-02
Completion date
2019-05-30
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activities of Daily Living, Balance, Mobility Limitation, Stroke

Keywords

stroke, community-based exercise program, task-oriented exercise, group exercise program, healthcare-recreation partnership, randomized controlled pilot trial, mixed methods

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.

Interventions

BEHAVIORALTogether in Movement and Exercise (TIME) Program

The TIME program is an evidence-based, standardized, progressive, licensed exercise program developed by physical therapists at the Toronto Rehabilitation Institute-University Health Network.

Sponsors

University Health Network, Toronto
CollaboratorOTHER
Heart and Stroke Foundation of Canada
CollaboratorOTHER
University of Western Ontario, Canada
CollaboratorOTHER
Ontario Stroke Network
CollaboratorOTHER
Institute for Clinical Evaluative Sciences
CollaboratorOTHER
University of Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors will be unaware of group assignment

Intervention model description

A 2-group randomized controlled trial in which participants are assigned to immediate or delayed participation in a community exercise program

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Stroke Impact ScaleBaseline, 3 months, 6 months, and 12 months59-item, self-report, 8 scales: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, participation.
Berg Balance TestBaseline, 3 months, 6 months, and 12 months14-items, objective measure designed to assess static balance and fall risk in adult populations
Activities-specific Balance Confidence (ABC) ScaleBaseline, 3 months, 6 months, and 12 months16-item, self-report; level of confidence in doing activities without losing balance or becoming unsteady
30-second Timed Sit-to-stand TestBaseline, 3 months, 6 months, and 12 monthsNumber 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
6-Minute Walk TestBaseline, 3 months, 6 months, and 12 monthsMaximum distance walked in 6 minutes (standard encouragement each minute) on a straight 30-metre path.
10-metre Walk TestBaseline, 3 months, 6 months, and 12 monthsTime taken to walk the middle 10 m of a 14-m walkway at a comfortable and maximum pace
Life Space Assessment questionnaireBaseline, 3 months, 6 months, and 12 months6-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
Canadian Study of Health and Aging-Clinical Frailty ScaleBaseline, 3 months, 6 months, and 12 monthsIndicates level of frailty of an individual based on impairments in mobility, function and self-rated health
Trail Making TestBaseline, 3 months, 6 months, and 12 monthsTrails 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.
Geriatric Depression Scale-Short VersionBaseline, 3 months, 6 months, and 12 months15-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.
Occurrence of injurious fallsMonthly, Months 1-12Participants are provided monthly falls calendar, coordinator contacts monthly to obtain details of any falls
Number of healthcare services utilized12 monthsPrimary 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
Type of healthcare services utilized12 monthsPrimary 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
Number of homecare servicesMonthly, Months 1-12Monthly details of services used
Type of homecare servicesMonthly, Months 1-12Monthly details of services used
Blood PressureBaseline, 3 months, 6 months, and 12 monthsSystolic/Diastolic Pressure
Heart Rate0.5 minutesHeart rate
Mobility aid typeBaseline, 3 months, 6 months, and 12 monthsTypes of mobility aids used
Mobility aid numberBaseline, 3 months, 6 months, and 12 monthsNumber of mobility aids used
Stroke characteristicBaselineDate, side and type of stroke
Stroke characteristic dateBaselineDate of stroke
Stroke sideBaselineSide of brain in which stroke occured
Stroke typeBaselineThe type of stroke
Sociodemographic data-ageBaselineAge in years
Sociodemographic data-sexBaselineSex
HeightBaseline, 3 months, 6 months, and 12 monthsHeight in meters
WeightBaseline, 3 months, 6 months, and 12 monthsWeight in Kg
Sociodemographic data-employmentBaselineEmployment Status
Education levelBaselineYears of education
Personal incomeBaselineCategory of personal income
Charlson Comorbidity IndexBaseline16-item scale to predict mortality. 8 items are given 1 point each, 8 other receive a score depending on the severity of condition
Co-intervention typeMonthly (1-12 months)Type of co-intervention
Co-intervention frequencyMonthly (1-12 months)Frequency of co-intervention
Caregiver Assistance ScaleBaseline, 3 months, 6 months, and 12 months17-item, caregiver self-report Indicates assistance provided to the care recipient in basic and instrumental ADLs and treatment-related activities
RandBaseline, 3 months, 6 months, and 12 monthsEmotional well-being and Energy/Fatigue Score, 9-item, self-report; Caregiver's perceived emotional status and energy levels over the past 4 weeks.
Time per week spent caregivingBaseline, 3 months, 6 months, and 12 monthsTime in hours
Costs reportBi-weekly (1-3 months)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
Barthel Index5 Baseline, 3 months, 6 months, and 12 months10-item, self-report or objective measure to assess level of independence in ability to perform basic activities of daily living
Intervention feasibility-attendance sheetBi-weekly (1-3 months)TIME Program attendance at Recreation Site-Completed by Fitness Instructors
PT Evaluation formWeekly (1-3 months)Evaluation conducted by Physical Therapist healthcare partner regarding the adherence to protocol
Adverse eventsWeekly (1-3 months)Adverse events occurring during the TIME exercise program; completed by fitness instructors
Intervention fidelity-activity checklistBi-weekly (1-3 months)TIME Program activities at Recreation Site-Completed by Fitness Instructors
EuroQol five dimensions questionnaireBaseline, 3 months, 6 months, and 12 months5-item, self report questionnaire to assess health utility

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026