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

NCT03122626 | Completed

• 1 other identifier: G-16-00013979
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (43)

• Barthel Index

  5 Baseline, 3 months, 6 months, and 12 months

• EuroQol five dimensions questionnaire

  Baseline, 3 months, 6 months, and 12 months

• Stroke Impact Scale

  Baseline, 3 months, 6 months, and 12 months

• Berg Balance Test

  Baseline, 3 months, 6 months, and 12 months

• Activities-specific Balance Confidence (ABC) Scale

  Baseline, 3 months, 6 months, and 12 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Wait-listed Control Group

NO INTERVENTION

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.

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Toronto, Department of Physical Therapy

Toronto, Ontario, M5G 1V7, Canada

Location

Related Publications (2)

• Aravind G, Bashir K, Cameron JI, Bayley MT, Teasell RW, Howe JA, Tee A, Jaglal SB, Hunter S, Salbach NM. What matters to program partners when implementing a community-based exercise program for people post-stroke? A theory-based qualitative study and cost analysis. Front Rehabil Sci. 2023 Aug 14;4:1064206. doi: 10.3389/fresc.2023.1064206. eCollection 2023.

  PMID: 37645234 DERIVED

• 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.

  PMID: 35459194 DERIVED

MeSH Terms

Conditions

Stroke; Mobility Limitation

Interventions

Movement; Exercise; Time

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity; Physical Phenomena

Study Officials

• Nancy Salbach, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be unaware of group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 21, 2017
• Study Start: February 2, 2017
• Primary Completion: February 28, 2019
• Study Completion: May 30, 2019
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)