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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
33
The TIME program is an evidence-based, standardized, progressive, licensed exercise program developed by physical therapists at the Toronto Rehabilitation Institute-University Health Network.
University of Toronto, Department of Physical Therapy
Toronto, Ontario, Canada
Subjective Index of Physical and Social Outcome (SIPSO)
10-item, self-report questionnaire. 2 subscales: physical function (5 items), social function (5 items)
Time frame: 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.
Time frame: Change from baseline to 3 months.
Barthel Index
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
EuroQol five dimensions questionnaire
5-item, self report questionnaire to assess health utility
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Number of homecare services
Monthly details of services used
Time frame: Monthly, Months 1-12
Type of homecare services
Monthly details of services used
Time frame: Monthly, Months 1-12
Blood Pressure
Systolic/Diastolic Pressure
Time frame: Baseline, 3 months, 6 months, and 12 months
Heart Rate
Heart rate
Time frame: 0.5 minutes
Mobility aid type
Types of mobility aids used
Time frame: Baseline, 3 months, 6 months, and 12 months
Mobility aid number
Number of mobility aids used
Time frame: Baseline, 3 months, 6 months, and 12 months
Stroke characteristic
Date, side and type of stroke
Time frame: Baseline
Stroke characteristic date
Date of stroke
Time frame: Baseline
Stroke side
Side of brain in which stroke occured
Time frame: Baseline
Stroke type
The type of stroke
Time frame: Baseline
Sociodemographic data-age
Age in years
Time frame: Baseline
Sociodemographic data-sex
Sex
Time frame: Baseline
Height
Height in meters
Time frame: Baseline, 3 months, 6 months, and 12 months
Weight
Weight in Kg
Time frame: Baseline, 3 months, 6 months, and 12 months
Sociodemographic data-employment
Employment Status
Time frame: Baseline
Education level
Years of education
Time frame: Baseline
Personal income
Category of personal income
Time frame: 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
Time frame: Baseline
Co-intervention type
Type of co-intervention
Time frame: Monthly (1-12 months)
Co-intervention frequency
Frequency of co-intervention
Time frame: 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
Time frame: 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.
Time frame: Baseline, 3 months, 6 months, and 12 months
Time per week spent caregiving
Time in hours
Time frame: 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
Time frame: Bi-weekly (1-3 months)
Intervention fidelity-activity checklist
TIME Program activities at Recreation Site-Completed by Fitness Instructors
Time frame: Bi-weekly (1-3 months)
Intervention feasibility-attendance sheet
TIME Program attendance at Recreation Site-Completed by Fitness Instructors
Time frame: Bi-weekly (1-3 months)
PT Evaluation form
Evaluation conducted by Physical Therapist healthcare partner regarding the adherence to protocol
Time frame: Weekly (1-3 months)
Adverse events
Adverse events occurring during the TIME exercise program; completed by fitness instructors
Time frame: Weekly (1-3 months)
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