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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122626
• Other study ID #: G-16-00013979
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: January 2021
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 30, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Activities of Daily Living
• Balance
• Mobility Limitation
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Toronto, Department of Physical Therapy	Toronto	Ontario

Sponsors (6)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	EuroQol five dimensions questionnaire	5-item, self report questionnaire to assess health utility	Baseline, 3 months, 6 months, and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Occurrence of injurious falls	Participants are provided monthly falls calendar, coordinator contacts monthly to obtain details of any falls	Monthly, Months 1-12
Secondary	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
Secondary	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
Secondary	Number of homecare services	Monthly details of services used	Monthly, Months 1-12
Secondary	Type of homecare services	Monthly details of services used	Monthly, Months 1-12
Secondary	Blood Pressure	Systolic/Diastolic Pressure	Baseline, 3 months, 6 months, and 12 months
Secondary	Heart Rate	Heart rate	0.5 minutes
Secondary	Mobility aid type	Types of mobility aids used	Baseline, 3 months, 6 months, and 12 months
Secondary	Mobility aid number	Number of mobility aids used	Baseline, 3 months, 6 months, and 12 months
Secondary	Stroke characteristic	Date, side and type of stroke	Baseline
Secondary	Stroke characteristic date	Date of stroke	Baseline
Secondary	Stroke side	Side of brain in which stroke occured	Baseline
Secondary	Stroke type	The type of stroke	Baseline
Secondary	Sociodemographic data-age	Age in years	Baseline
Secondary	Sociodemographic data-sex	Sex	Baseline
Secondary	Height	Height in meters	Baseline, 3 months, 6 months, and 12 months
Secondary	Weight	Weight in Kg	Baseline, 3 months, 6 months, and 12 months
Secondary	Sociodemographic data-employment	Employment Status	Baseline
Secondary	Education level	Years of education	Baseline
Secondary	Personal income	Category of personal income	Baseline
Secondary	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
Secondary	Co-intervention type	Type of co-intervention	Monthly (1-12 months)
Secondary	Co-intervention frequency	Frequency of co-intervention	Monthly (1-12 months)
Secondary	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
Secondary	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
Secondary	Time per week spent caregiving	Time in hours	Baseline, 3 months, 6 months, and 12 months
Secondary	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)
Secondary	Intervention fidelity-activity checklist	TIME Program activities at Recreation Site-Completed by Fitness Instructors	Bi-weekly (1-3 months)
Secondary	Intervention feasibility-attendance sheet	TIME Program attendance at Recreation Site-Completed by Fitness Instructors	Bi-weekly (1-3 months)
Secondary	PT Evaluation form	Evaluation conducted by Physical Therapist healthcare partner regarding the adherence to protocol	Weekly (1-3 months)
Secondary	Adverse events	Adverse events occurring during the TIME exercise program; completed by fitness instructors	Weekly (1-3 months)