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

Primary Purpose

Stroke, Balance, Mobility Limitation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Together in Movement and Exercise (TIME) Program
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, community-based exercise program, task-oriented exercise, group exercise program, healthcare-recreation partnership, randomized controlled pilot trial, mixed methods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Toronto, Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Wait-listed Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Barthel Index
10-item, self-report or objective measure to assess level of independence in ability to perform basic activities of daily living
EuroQol five dimensions questionnaire
5-item, self report questionnaire to assess health utility
Stroke Impact Scale
59-item, self-report, 8 scales: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, participation.
Berg Balance Test
14-items, objective measure designed to assess static balance and fall risk in adult populations
Activities-specific Balance Confidence (ABC) Scale
16-item, self-report; level of confidence in doing activities without losing balance or becoming unsteady
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
6-Minute Walk Test
Maximum distance walked in 6 minutes (standard encouragement each minute) on a straight 30-metre path.
10-metre Walk Test
Time taken to walk the middle 10 m of a 14-m walkway at a comfortable and maximum pace
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
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
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.
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.
Occurrence of injurious falls
Participants are provided monthly falls calendar, coordinator contacts monthly to obtain details of any falls
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
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
Number of homecare services
Monthly details of services used
Type of homecare services
Monthly details of services used
Blood Pressure
Systolic/Diastolic Pressure
Heart Rate
Heart rate
Mobility aid type
Types of mobility aids used
Mobility aid number
Number of mobility aids used
Stroke characteristic
Date, side and type of stroke
Stroke characteristic date
Date of stroke
Stroke side
Side of brain in which stroke occured
Stroke type
The type of stroke
Sociodemographic data-age
Age in years
Sociodemographic data-sex
Sex
Height
Height in meters
Weight
Weight in Kg
Sociodemographic data-employment
Employment Status
Education level
Years of education
Personal income
Category of personal income
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
Co-intervention type
Type of co-intervention
Co-intervention frequency
Frequency of co-intervention
Caregiver Assistance Scale
17-item, caregiver self-report Indicates assistance provided to the care recipient in basic and instrumental ADLs and treatment-related activities
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.
Time per week spent caregiving
Time in hours
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
Intervention fidelity-activity checklist
TIME Program activities at Recreation Site-Completed by Fitness Instructors
Intervention feasibility-attendance sheet
TIME Program attendance at Recreation Site-Completed by Fitness Instructors
PT Evaluation form
Evaluation conducted by Physical Therapist healthcare partner regarding the adherence to protocol
Adverse events
Adverse events occurring during the TIME exercise program; completed by fitness instructors

Full Information

First Posted
April 10, 2017
Last Updated
January 8, 2021
Sponsor
University of Toronto
Collaborators
University Health Network, Toronto, Heart and Stroke Foundation of Canada, University of Western Ontario, Canada, Ontario Stroke Network, Institute for Clinical Evaluative Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03122626
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
University Health Network, Toronto, Heart and Stroke Foundation of Canada, University of Western Ontario, Canada, Ontario Stroke Network, Institute for Clinical Evaluative Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A 2-group randomized controlled trial in which participants are assigned to immediate or delayed participation in a community exercise program
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be unaware of group assignment
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-listed Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Together in Movement and Exercise (TIME) Program
Intervention Description
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 Outcome Measure Information:
Title
Subjective Index of Physical and Social Outcome (SIPSO)
Description
10-item, self-report questionnaire. 2 subscales: physical function (5 items), social function (5 items)
Time Frame
Change from baseline to 3 months.
Title
Nottingham Extended Activities of Daily Living (NEADL)
Description
22-item, self-report performance of instrumental ADL in 4 categories: mobility, kitchen, domestic, and leisure.
Time Frame
Change from baseline to 3 months.
Secondary Outcome Measure Information:
Title
Barthel Index
Description
10-item, self-report or objective measure to assess level of independence in ability to perform basic activities of daily living
Time Frame
5 Baseline, 3 months, 6 months, and 12 months
Title
EuroQol five dimensions questionnaire
Description
5-item, self report questionnaire to assess health utility
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Stroke Impact Scale
Description
59-item, self-report, 8 scales: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, participation.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Berg Balance Test
Description
14-items, objective measure designed to assess static balance and fall risk in adult populations
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Activities-specific Balance Confidence (ABC) Scale
Description
16-item, self-report; level of confidence in doing activities without losing balance or becoming unsteady
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
30-second Timed Sit-to-stand Test
Description
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
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
6-Minute Walk Test
Description
Maximum distance walked in 6 minutes (standard encouragement each minute) on a straight 30-metre path.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
10-metre Walk Test
Description
Time taken to walk the middle 10 m of a 14-m walkway at a comfortable and maximum pace
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Life Space Assessment questionnaire
Description
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
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Canadian Study of Health and Aging-Clinical Frailty Scale
Description
Indicates level of frailty of an individual based on impairments in mobility, function and self-rated health
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Trail Making Test
Description
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.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Geriatric Depression Scale-Short Version
Description
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.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Occurrence of injurious falls
Description
Participants are provided monthly falls calendar, coordinator contacts monthly to obtain details of any falls
Time Frame
Monthly, Months 1-12
Title
Number of healthcare services utilized
Description
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
Time Frame
12 months
Title
Type of healthcare services utilized
Description
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
Time Frame
12 months
Title
Number of homecare services
Description
Monthly details of services used
Time Frame
Monthly, Months 1-12
Title
Type of homecare services
Description
Monthly details of services used
Time Frame
Monthly, Months 1-12
Title
Blood Pressure
Description
Systolic/Diastolic Pressure
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Heart Rate
Description
Heart rate
Time Frame
0.5 minutes
Title
Mobility aid type
Description
Types of mobility aids used
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Mobility aid number
Description
Number of mobility aids used
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Stroke characteristic
Description
Date, side and type of stroke
Time Frame
Baseline
Title
Stroke characteristic date
Description
Date of stroke
Time Frame
Baseline
Title
Stroke side
Description
Side of brain in which stroke occured
Time Frame
Baseline
Title
Stroke type
Description
The type of stroke
Time Frame
Baseline
Title
Sociodemographic data-age
Description
Age in years
Time Frame
Baseline
Title
Sociodemographic data-sex
Description
Sex
Time Frame
Baseline
Title
Height
Description
Height in meters
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Weight
Description
Weight in Kg
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Sociodemographic data-employment
Description
Employment Status
Time Frame
Baseline
Title
Education level
Description
Years of education
Time Frame
Baseline
Title
Personal income
Description
Category of personal income
Time Frame
Baseline
Title
Charlson Comorbidity Index
Description
16-item scale to predict mortality. 8 items are given 1 point each, 8 other receive a score depending on the severity of condition
Time Frame
Baseline
Title
Co-intervention type
Description
Type of co-intervention
Time Frame
Monthly (1-12 months)
Title
Co-intervention frequency
Description
Frequency of co-intervention
Time Frame
Monthly (1-12 months)
Title
Caregiver Assistance Scale
Description
17-item, caregiver self-report Indicates assistance provided to the care recipient in basic and instrumental ADLs and treatment-related activities
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Rand
Description
Emotional well-being and Energy/Fatigue Score, 9-item, self-report; Caregiver's perceived emotional status and energy levels over the past 4 weeks.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Time per week spent caregiving
Description
Time in hours
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Costs report
Description
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
Time Frame
Bi-weekly (1-3 months)
Title
Intervention fidelity-activity checklist
Description
TIME Program activities at Recreation Site-Completed by Fitness Instructors
Time Frame
Bi-weekly (1-3 months)
Title
Intervention feasibility-attendance sheet
Description
TIME Program attendance at Recreation Site-Completed by Fitness Instructors
Time Frame
Bi-weekly (1-3 months)
Title
PT Evaluation form
Description
Evaluation conducted by Physical Therapist healthcare partner regarding the adherence to protocol
Time Frame
Weekly (1-3 months)
Title
Adverse events
Description
Adverse events occurring during the TIME exercise program; completed by fitness instructors
Time Frame
Weekly (1-3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Salbach, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto, Department of Physical Therapy
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35459194
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.
Results Reference
derived

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

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