StrokeNCT03122626
Does a Group, Task-oriented Community-based Exercise Program Improve Everyday Function in People With Stroke?
A study testing Together in Movement and Exercise (TIME) Program in people with Stroke and Balance, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Balance, Mobility Limitation
- What is being tested?
- Together in Movement and Exercise (TIME) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 2 Feb 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto, Department of Physical Therapy
Toronto, Ontario, M5G 1V7
About this study
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
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.
Read more
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
- Being tested
- Together in Movement and Exercise (TIME) Program
- Keywords
- stroke, community-based exercise program, task-oriented exercise, group exercise program, healthcare-recreation partnership, randomized controlled pilot trial, mixed methods
- Medical subject headings
- Stroke, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Together in Movement and Exercise (TIME) ProgramBehavioural
The TIME program is an evidence-based, standardized, progressive, licensed exercise program developed by physical therapists at the Toronto Rehabilitation Institute-University Health Network.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Index of Physical and Social Outcome (SIPSO)
10-item, self-report questionnaire. 2 subscales: physical function (5 items), social function (5 items)
Measured: 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.
Measured: Change from baseline to 3 months.
Secondary outcomes (43)
Barthel Index
10-item, self-report or objective measure to assess level of independence in ability to perform basic activities of daily living
Measured: 5 Baseline, 3 months, 6 months, and 12 months
EuroQol five dimensions questionnaire
5-item, self report questionnaire to assess health utility
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Number of homecare services
Monthly details of services used
Measured: Monthly, Months 1-12
Type of homecare services
Monthly details of services used
Measured: Monthly, Months 1-12
Blood Pressure
Systolic/Diastolic Pressure
Measured: Baseline, 3 months, 6 months, and 12 months
Heart Rate
Heart rate
Measured: 0.5 minutes
Mobility aid type
Types of mobility aids used
Measured: Baseline, 3 months, 6 months, and 12 months
Mobility aid number
Number of mobility aids used
Measured: Baseline, 3 months, 6 months, and 12 months
Stroke characteristic
Date, side and type of stroke
Measured: Baseline
Stroke characteristic date
Date of stroke
Measured: Baseline
Stroke side
Side of brain in which stroke occured
Measured: Baseline
Stroke type
The type of stroke
Measured: Baseline
Sociodemographic data-age
Age in years
Measured: Baseline
Sociodemographic data-sex
Sex
Measured: Baseline
Height
Height in meters
Measured: Baseline, 3 months, 6 months, and 12 months
Weight
Weight in Kg
Measured: Baseline, 3 months, 6 months, and 12 months
Sociodemographic data-employment
Employment Status
Measured: Baseline
Education level
Years of education
Measured: Baseline
Personal income
Category of personal income
Measured: 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
Measured: Baseline
Co-intervention type
Type of co-intervention
Measured: Monthly (1-12 months)
Co-intervention frequency
Frequency of co-intervention
Measured: 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
Measured: 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.
Measured: Baseline, 3 months, 6 months, and 12 months
Time per week spent caregiving
Time in hours
Measured: 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
Measured: Bi-weekly (1-3 months)
Intervention fidelity-activity checklist
TIME Program activities at Recreation Site-Completed by Fitness Instructors
Measured: Bi-weekly (1-3 months)
Intervention feasibility-attendance sheet
TIME Program attendance at Recreation Site-Completed by Fitness Instructors
Measured: Bi-weekly (1-3 months)
PT Evaluation form
Evaluation conducted by Physical Therapist healthcare partner regarding the adherence to protocol
Measured: Weekly (1-3 months)
Adverse events
Adverse events occurring during the TIME exercise program; completed by fitness instructors
Measured: Weekly (1-3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start2 Feb 2017
- Primary completion28 Feb 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2-group randomized controlled trial in which participants are assigned to immediate or delayed participation in a community exercise program
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Heart and Stroke Foundation of Canada, University of Western Ontario, Canada, Ontario Stroke Network, Institute for Clinical Evaluative Sciences
- Responsible party
- Principal investigator, Dr. Nancy Salbach, University of Toronto
- Investigators
- Nancy Salbach, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122626
- Sponsor's protocol ID
- G-16-00013979
- Status last verified
- Jan 2021
- First submitted
- 10 Apr 2017
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37645234Aravind 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.
PubMed 35459194
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03122626
- Acronym / sponsor ID
- G-16-00013979
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Heart and Stroke Foundation of Canada, University of Western Ontario, Canada, Ontario Stroke Network, Institute for Clinical Evaluative Sciences
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A 2-group randomized controlled trial in which participants are assigned to immediate or delayed participation in a community exercise program
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Together in Movement and Exercise (TIME) ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Together in Movement and Exercise (TIME) ProgramThe TIME program is an evidence-based, standardized, progressive, licensed exercise program developed by physical therapists at the Toronto Rehabilitation Institute-University Health Network. | Behavioural | Experimental Group |
Primary outcome
Subjective Index of Physical and Social Outcome (SIPSO)
Time frame: Change from baseline to 3 months.
10-item, self-report questionnaire. 2 subscales: physical function (5 items), social function (5 items)
Nottingham Extended Activities of Daily Living (NEADL)
Time frame: Change from baseline to 3 months.
22-item, self-report performance of instrumental ADL in 4 categories: mobility, kitchen, domestic, and leisure.
43 secondary outcomes
Barthel Index
Time frame: 5 Baseline, 3 months, 6 months, and 12 months
EuroQol five dimensions questionnaire
Time frame: Baseline, 3 months, 6 months, and 12 months
Stroke Impact Scale
Time frame: Baseline, 3 months, 6 months, and 12 months
Berg Balance Test
Time frame: Baseline, 3 months, 6 months, and 12 months
Activities-specific Balance Confidence (ABC) Scale
Time frame: Baseline, 3 months, 6 months, and 12 months
30-second Timed Sit-to-stand Test
Time frame: Baseline, 3 months, 6 months, and 12 months
6-Minute Walk Test
Time frame: Baseline, 3 months, 6 months, and 12 months
10-metre Walk Test
Time frame: Baseline, 3 months, 6 months, and 12 months
Life Space Assessment questionnaire
Time frame: Baseline, 3 months, 6 months, and 12 months
Canadian Study of Health and Aging-Clinical Frailty Scale
Time frame: Baseline, 3 months, 6 months, and 12 months
Trail Making Test
Time frame: Baseline, 3 months, 6 months, and 12 months
Geriatric Depression Scale-Short Version
Time frame: Baseline, 3 months, 6 months, and 12 months
Occurrence of injurious falls
Time frame: Monthly, Months 1-12
Number of healthcare services utilized
Time frame: 12 months
Type of healthcare services utilized
Time frame: 12 months
Number of homecare services
Time frame: Monthly, Months 1-12
Type of homecare services
Time frame: Monthly, Months 1-12
Blood Pressure
Time frame: Baseline, 3 months, 6 months, and 12 months
Heart Rate
Time frame: 0.5 minutes
Mobility aid type
Time frame: Baseline, 3 months, 6 months, and 12 months
Mobility aid number
Time frame: Baseline, 3 months, 6 months, and 12 months
Stroke characteristic
Time frame: Baseline
Stroke characteristic date
Time frame: Baseline
Stroke side
Time frame: Baseline
Stroke type
Time frame: Baseline
Sociodemographic data-age
Time frame: Baseline
Sociodemographic data-sex
Time frame: Baseline
Height
Time frame: Baseline, 3 months, 6 months, and 12 months
Weight
Time frame: Baseline, 3 months, 6 months, and 12 months
Sociodemographic data-employment
Time frame: Baseline
Education level
Time frame: Baseline
Personal income
Time frame: Baseline
Charlson Comorbidity Index
Time frame: Baseline
Co-intervention type
Time frame: Monthly (1-12 months)
Co-intervention frequency
Time frame: Monthly (1-12 months)
Caregiver Assistance Scale
Time frame: Baseline, 3 months, 6 months, and 12 months
Rand
Time frame: Baseline, 3 months, 6 months, and 12 months
Time per week spent caregiving
Time frame: Baseline, 3 months, 6 months, and 12 months
Costs report
Time frame: Bi-weekly (1-3 months)
Intervention fidelity-activity checklist
Time frame: Bi-weekly (1-3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Derived from this study: PubMed 37645234Aravind 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.
- Derived from this study: PubMed 35459194Aravind 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Salbach, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Together in Movement and Exercise (TIME) Program in people with Stroke and Balance, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Index of Physical and Social Outcome (SIPSO) (time frame: Change from baseline to 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03122626, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.