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Completed

NCT Number: NCT03122626

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

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.

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Key information

Conditions

Stroke Activities of Daily Living Balance Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mobility Limitation Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto, Department of Physical Therapy

Toronto, Ontario, M5G 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Together in Movement and Exercise (TIME) Program

Behavioral

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

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. Barthel Index

    Time frame: 5 Baseline, 3 months, 6 months, and 12 months

    10-item, self-report or objective measure to assess level of independence in ability to perform basic activities of daily living

  2. EuroQol five dimensions questionnaire

    Time frame: Baseline, 3 months, 6 months, and 12 months

    5-item, self report questionnaire to assess health utility

  3. Stroke Impact Scale

    Time frame: Baseline, 3 months, 6 months, and 12 months

    59-item, self-report, 8 scales: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, participation.

  4. Berg Balance Test

    Time frame: Baseline, 3 months, 6 months, and 12 months

    14-items, objective measure designed to assess static balance and fall risk in adult populations

  5. Activities-specific Balance Confidence (ABC) Scale

    Time frame: Baseline, 3 months, 6 months, and 12 months

    16-item, self-report; level of confidence in doing activities without losing balance or becoming unsteady

  6. 30-second Timed Sit-to-stand Test

    Time frame: Baseline, 3 months, 6 months, and 12 months

    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

  7. 6-Minute Walk Test

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Maximum distance walked in 6 minutes (standard encouragement each minute) on a straight 30-metre path.

  8. 10-metre Walk Test

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Time taken to walk the middle 10 m of a 14-m walkway at a comfortable and maximum pace

  9. Life Space Assessment questionnaire

    Time frame: Baseline, 3 months, 6 months, and 12 months

    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

  10. Canadian Study of Health and Aging-Clinical Frailty Scale

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Indicates level of frailty of an individual based on impairments in mobility, function and self-rated health

  11. Trail Making Test

    Time frame: Baseline, 3 months, 6 months, and 12 months

    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.

  12. Geriatric Depression Scale-Short Version

    Time frame: Baseline, 3 months, 6 months, and 12 months

    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.

  13. Occurrence of injurious falls

    Time frame: Monthly, Months 1-12

    Participants are provided monthly falls calendar, coordinator contacts monthly to obtain details of any falls

  14. Number of healthcare services utilized

    Time frame: 12 months

    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

  15. Type of healthcare services utilized

    Time frame: 12 months

    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

  16. Number of homecare services

    Time frame: Monthly, Months 1-12

    Monthly details of services used

  17. Type of homecare services

    Time frame: Monthly, Months 1-12

    Monthly details of services used

  18. Blood Pressure

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Systolic/Diastolic Pressure

  19. Heart Rate

    Time frame: 0.5 minutes

    Heart rate

  20. Mobility aid type

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Types of mobility aids used

  21. Mobility aid number

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Number of mobility aids used

  22. Stroke characteristic

    Time frame: Baseline

    Date, side and type of stroke

  23. Stroke characteristic date

    Time frame: Baseline

    Date of stroke

  24. Stroke side

    Time frame: Baseline

    Side of brain in which stroke occured

  25. Stroke type

    Time frame: Baseline

    The type of stroke

  26. Sociodemographic data-age

    Time frame: Baseline

    Age in years

  27. Sociodemographic data-sex

    Time frame: Baseline

    Sex

  28. Height

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Height in meters

  29. Weight

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Weight in Kg

  30. Sociodemographic data-employment

    Time frame: Baseline

    Employment Status

  31. Education level

    Time frame: Baseline

    Years of education

  32. Personal income

    Time frame: Baseline

    Category of personal income

  33. Charlson Comorbidity Index

    Time frame: Baseline

    16-item scale to predict mortality. 8 items are given 1 point each, 8 other receive a score depending on the severity of condition

  34. Co-intervention type

    Time frame: Monthly (1-12 months)

    Type of co-intervention

  35. Co-intervention frequency

    Time frame: Monthly (1-12 months)

    Frequency of co-intervention

  36. Caregiver Assistance Scale

    Time frame: Baseline, 3 months, 6 months, and 12 months

    17-item, caregiver self-report Indicates assistance provided to the care recipient in basic and instrumental ADLs and treatment-related activities

  37. Rand

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Emotional well-being and Energy/Fatigue Score, 9-item, self-report; Caregiver's perceived emotional status and energy levels over the past 4 weeks.

  38. Time per week spent caregiving

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Time in hours

  39. Costs report

    Time frame: Bi-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

  40. Intervention fidelity-activity checklist

    Time frame: Bi-weekly (1-3 months)

    TIME Program activities at Recreation Site-Completed by Fitness Instructors

  41. Intervention feasibility-attendance sheet

    Time frame: Bi-weekly (1-3 months)

    TIME Program attendance at Recreation Site-Completed by Fitness Instructors

  42. PT Evaluation form

    Time frame: Weekly (1-3 months)

    Evaluation conducted by Physical Therapist healthcare partner regarding the adherence to protocol

  43. Adverse events

    Time frame: Weekly (1-3 months)

    Adverse events occurring during the TIME exercise program; completed by fitness instructors

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2017
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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