Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-07-19
2026-03-31
Brief Summary
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The main questions the trial aims to answer are:
1. Will there be improvements in physical and mental health outcomes, and caregiver mood and assistance, following participation in the TIME™ at Home exercise program that are greater than in the waitlist control group?
2. Will level of mobility limitation, sex, or gender influence the experiences of people in the exercise program?
3. What will be the costs of the TIME™ at Home exercise program for the organization delivering the program, and the people who are in the exercise program?
Participants and their caregivers will be asked to complete 3 evaluations using Zoom at study entry and 2 and 5 months later.
* Participants will complete tests of balance and walking and questionnaires.
* Caregivers will only complete questionnaires.
After the first evaluation, participants will be randomly assigned to either participate in:
* the 8-week TIME™ at Home exercise program from their homes using Zoom, or
* to wait 5 months (waitlist control group) before beginning the 8-week TIME™ at Home exercise program
Detailed Description
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The objectives of the TIME™ at Home randomized controlled trial are:
1. To estimate the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) compared to a waitlist control on improving everyday function (primary outcome), mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, and caregiver confidence in care-recipient balance (secondary outcomes) in community-dwelling adults with mobility limitations;
2. To determine whether level of mobility limitation, sex, or gender, modifies the effect of the TIME™ at Home program compared to a waitlist control in improving everyday function;
3. To assess the cost-effectiveness of the TIME™ at Home program from a societal perspective; and
4. To explore exercise participants', caregivers' and program providers' experiences during the intervention phase.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TIME at Home
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.
TIME at Home
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.
Waitlist
Individuals in the waitlist control group will receive the TIME at Home program following the final 5-month evaluation.
No interventions assigned to this group
Interventions
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TIME at Home
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.
Eligibility Criteria
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Inclusion Criteria
2. mobility limitations (eg, need to use a walking aid, difficulty stepping onto curbs, ramps, stairs, or walk on uneven surfaces);
3. living independently in the community (in own home or assisted living settings);
4. able to walk a minimum of 10 metres independently (with walking aids if used) without assistance and/or supervision from another person;
5. able to stand up from and sit down onto a chair independently, without supervision;
6. able to maintain balance while exercising in standing (e.g., marching on the spot) holding onto the back of a chair or a sturdy countertop;
7. has a study partner (e.g., caregiver, family member or friend) willing to be present, at minimum, during the first evaluation in the home via Zoom;
8. able to speak and read English to understand informed consent and follow instructions for study procedures and exercises;
1. caregiver defined as an individual who helps the exercise participant to live at home by providing support and assistance with at least one basic (e.g., self-care) and/or instrumental activity of daily living (e.g., doing groceries, cleaning, managing finances, making meals, doing laundry, etc.) at least once a week;
2. able to speak and read English.
Exclusion Criteria
2. previous participation in the TIME at Home exercise program;
3. health conditions or symptoms preventing participation in exercise;
4. cognitive impairment, defined as a score of \<11/15 on the 5-minute Montreal Cognitive Assessment (MoCA);
5. severe visual impairment;
6. severe hearing impairment
Caregivers
1\. Is a paid personal support worker.
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
March of Dimes, Canada
OTHER
Heart and Stroke Foundation of Canada
OTHER
University of Alberta
OTHER
University of Manitoba
OTHER
Bruyère Health Research Institute.
OTHER
University of Toronto
OTHER
Responsible Party
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Dr. Nancy Salbach
Professor
Principal Investigators
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Nancy Salbach, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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University of Alberta
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Bruyère Research Institute
Ottawa, Ontario, Canada
University of Toronto
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Doyeon Hwang, MScPH
Role: primary
Roheema Ewesesan, MD
Role: primary
Asefeh Memarian, MSc
Role: primary
Renato Barbosa dos Santos, MSc
Role: primary
References
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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.
Other Identifiers
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45343
Identifier Type: -
Identifier Source: org_study_id