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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
| March of Dimes, Canada | OTHER |
| Heart and Stroke Foundation of Canada | OTHER |
| University of Alberta |
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The goal of this randomized controlled trial is to compare the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) with a waitlist control in community-dwelling adults with balance and mobility limitations.
The main questions the trial aims to answer are:
Participants and their caregivers will be asked to complete 3 evaluations using Zoom at study entry and 2 and 5 months later.
After the first evaluation, participants will be randomly assigned to either participate in:
Mobility limitations are highly prevalent, limit everyday functioning, and increase the need for caregiver assistance in people with chronic health conditions, such as stroke, and multiple sclerosis. While community exercise programs have been shown to improve physical and mental health, older adults with mobility limitations face numerous challenges with attending in-person community exercise programs. Challenges relate to the availability and cost of transportation, inclement weather, inadequate building access, program cost, risk of infection, and pandemic-related program closures. In addition, caregivers commonly need to provide transportation, which can take time away from paid employment and other daily activities. Some recreation centres do not have the funding to operate exercise programs for people with balance and mobility limitations that require instructors with specialized skills and a high level of exercise supervision.
The objectives of the TIME™ at Home randomized controlled trial are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIME at Home | Experimental | TIME at Home is a virtual, group, task-oriented exercise program targeting balance and mobility. A community organization delivers two 1.5-hour sessions per week, for 8 weeks using Zoom. |
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| Waitlist | No Intervention | Individuals in the waitlist control group will receive the TIME at Home program following the final 5-month evaluation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIME at Home | Behavioral | Sessions involve a 15-minute pre-video safety check and social time; streaming a 1-hour pre-recorded exercise video; and a 15-minute post-video social time. Two trained facilitators run each class, with a maximum group size of 10 people. The 1-hour exercise videos include a seated warm-up and cooldown, and 40 minutes of functional, self-paced exercises. In the video, 2 healthcare professionals demonstrate a lower and higher difficulty level of each exercise. The program starts with a level 1 video and switches to a level 2 video midway. A registered healthcare professional, called the healthcare partner, visits select classes and serves as a resource to participants and facilitators. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months | Score from 0 to 20 points, 5-item self-report scale measuring everyday functioning | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 7-item Berg balance scale (7BBS) | Score from 0 to 28 points on 7-item performance-based measure | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| 30-second sit-to-stand test (30STS) |
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Inclusion Criteria:
Exclusion Criteria:
Caregivers
Inclusion criteria:
Exclusion criteria:
1. Is a paid personal support worker.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renato Barbosa dos Santos, MSc | Contact | 416-946-7579 | timestudy@utoronto.ca | |
| Nancy Salbach, PhD | Contact | 416-946-8558 | nancy.salbach@utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nancy Salbach, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Recruiting | Edmonton | Alberta | T6G 2G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40721264 | Derived | Salbach NM, Jones CA, Barclay R, Sveistrup H, Sheehy L, Bayley MT, Inness EL, Legasto-Mulvale JM, Barbosa Dos Santos R, Fung J, Moineddin R, Teasell RW, Catizzone M, Hovanec N, Cameron JI, Munce S, O'Neil J, Jaglal SB, Aravind G, Su TT, Hanson HM. Short-term effects of a virtual, community-based, task-oriented group exercise programme incorporating a healthcare-community partnership compared to a waitlist control on increasing everyday function among adults with mobility limitations: protocol for the TIME at Home randomised controlled trial. BMJ Open. 2025 Jul 28;15(7):e102694. doi: 10.1136/bmjopen-2025-102694. |
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The anonymized data collected during the study, the trial protocol, statistical analysis plan, and informed consent form, will be shared with qualified researchers engaging in REB-approved independent scientific research, upon request to the research team.
After the study ends.
Please contact the research team
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| University of Manitoba | OTHER |
| Bruyère Health Research Institute. | OTHER |
Parallel assignment
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Single: Outcomes Assessor
|
Number of stands completed in 30 seconds
| 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| Timed 'up and go' (TUG) test | Time in seconds, taken to stand up from a standard armchair, walk a distance of 3 metres, turn around, walk back to the chair, and sit down again | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| 3-metre walk test (3mWT, comfortable pace) | Comfortable walking speed in metres/second based on time taken to walk 3 metres | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| 3-metre walk test (3mWT, fast pace) | Fast walking speed in metres/second based on time taken to walk 3 metres | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| 2-minute step test (2ST) | Number of times the knee reaches the required height in 2 minutes | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| Activities-specific balance confidence (ABC) scale | Score from 0 to 100 points on the 16-item self-report scale | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| Center for epidemiological studies depression (CES-D) scale | Score from 0 to 60 points on the 20-item self-report scale | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| PROMIS v2.0 Social Isolation short form | Score from 0 to 20 points on the 4-item self-report scale | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| EuroQoL-5D-5L visual analog scale (EQ-VAS) | Score from 0 to 100 points on the visual analog scale | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| Caregiver Assistance Scale (CAS) | Score from 0 to 102 points on the 17-item self-report scale, completed by caregiver | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| Center for epidemiological studies depression (CES-D) scale-Caregiver | Score from 0 to 60 points on the 20-item self-report scale, completed by caregiver | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| Activities-specific balance confidence (ABC) scale-Caregiver | Score from 0 to 100 points on the 16-item self-report scale, completed by caregiver | 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) |
| Program delivery cost | Cost ($) for community organizations to run the TIME at Home program in the Experimental group | 2 months (immediately post-intervention) |
| Cost ($) of exercise participation | Cost ($) for a participant in the Experimental group to participate in the TIME at Home program | 2 months (immediately post-intervention) |
| Amount ($) willing to pay to register for TIME at Home | Amount ($) that participants in the Experimental group would be willing to pay out-of-pocket to receive the program | 2 months (immediately post-intervention) |
| Quality-adjusted life-years (QALYs) | Scores on the EQ-5D-5L convert to a single index value used to calculate quality-adjusted life-years (QALYs) | 2 months (immediately post-intervention) |
| University of Manitoba | Recruiting | Winnipeg | Manitoba | R3E 0T6 | Canada |
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| Bruyère Research Institute | Recruiting | Ottawa | Ontario | K1N 5C8 | Canada |
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| University of Toronto | Recruiting | Toronto | Ontario | M5G 1V7 | Canada |
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