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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Activities of Daily Living; Mobility Limitation; Balance
• Intervention / Treatment: Behavioral: Together in Movement and Exercise (TIME) Program

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1V7
      • University of Toronto, Department of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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.	Behavioral: Together 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.
No Intervention: Wait-listed Control Group; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index	10-item, self-report or objective measure to assess level of independence in ability to perform basic activities of daily living	5 Baseline, 3 months, 6 months, and 12 months
EuroQol five dimensions questionnaire	5-item, self report questionnaire to assess health utility	Baseline, 3 months, 6 months, and 12 months
Stroke Impact Scale	59-item, self-report, 8 scales: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, participation.	Baseline, 3 months, 6 months, and 12 months
Berg Balance Test	14-items, objective measure designed to assess static balance and fall risk in adult populations	Baseline, 3 months, 6 months, and 12 months
Activities-specific Balance Confidence (ABC) Scale	16-item, self-report; level of confidence in doing activities without losing balance or becoming unsteady	Baseline, 3 months, 6 months, and 12 months
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	Baseline, 3 months, 6 months, and 12 months
6-Minute Walk Test	Maximum distance walked in 6 minutes (standard encouragement each minute) on a straight 30-metre path.	Baseline, 3 months, 6 months, and 12 months
10-metre Walk Test	Time taken to walk the middle 10 m of a 14-m walkway at a comfortable and maximum pace	Baseline, 3 months, 6 months, and 12 months
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	Baseline, 3 months, 6 months, and 12 months
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	Baseline, 3 months, 6 months, and 12 months
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.	Baseline, 3 months, 6 months, and 12 months
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.	Baseline, 3 months, 6 months, and 12 months
Occurrence of injurious falls	Participants are provided monthly falls calendar, coordinator contacts monthly to obtain details of any falls	Monthly, Months 1-12
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	12 months
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	12 months
Number of homecare services	Monthly details of services used	Monthly, Months 1-12
Type of homecare services	Monthly details of services used	Monthly, Months 1-12
Blood Pressure	Systolic/Diastolic Pressure	Baseline, 3 months, 6 months, and 12 months
Heart Rate	Heart rate	0.5 minutes
Mobility aid type	Types of mobility aids used	Baseline, 3 months, 6 months, and 12 months
Mobility aid number	Number of mobility aids used	Baseline, 3 months, 6 months, and 12 months
Stroke characteristic	Date, side and type of stroke	Baseline
Stroke characteristic date	Date of stroke	Baseline
Stroke side	Side of brain in which stroke occured	Baseline
Stroke type	The type of stroke	Baseline
Sociodemographic data-age	Age in years	Baseline
Sociodemographic data-sex	Sex	Baseline
Height	Height in meters	Baseline, 3 months, 6 months, and 12 months
Weight	Weight in Kg	Baseline, 3 months, 6 months, and 12 months
Sociodemographic data-employment	Employment Status	Baseline
Education level	Years of education	Baseline
Personal income	Category of personal income	Baseline
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	Baseline
Co-intervention type	Type of co-intervention	Monthly (1-12 months)
Co-intervention frequency	Frequency of co-intervention	Monthly (1-12 months)
Caregiver Assistance Scale	17-item, caregiver self-report Indicates assistance provided to the care recipient in basic and instrumental ADLs and treatment-related activities	Baseline, 3 months, 6 months, and 12 months
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.	Baseline, 3 months, 6 months, and 12 months
Time per week spent caregiving	Time in hours	Baseline, 3 months, 6 months, and 12 months
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	Bi-weekly (1-3 months)
Intervention fidelity-activity checklist	TIME Program activities at Recreation Site-Completed by Fitness Instructors	Bi-weekly (1-3 months)
Intervention feasibility-attendance sheet	TIME Program attendance at Recreation Site-Completed by Fitness Instructors	Bi-weekly (1-3 months)
PT Evaluation form	Evaluation conducted by Physical Therapist healthcare partner regarding the adherence to protocol	Weekly (1-3 months)
Adverse events	Adverse events occurring during the TIME exercise program; completed by fitness instructors	Weekly (1-3 months)

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: University Health Network, Toronto; University of Western Ontario, Canada; Institute for Clinical Evaluative Sciences; Heart and Stroke Foundation of Canada; Ontario Stroke Network
• Investigators: Principal Investigator: Nancy Salbach, PhD, University of Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: stroke; community-based exercise program; task-oriented exercise; group exercise program; healthcare-recreation partnership; randomized controlled pilot trial; mixed methods
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Mobility Limitation
• Other Study ID Numbers: G-16-00013979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No