TIME™ at Home Randomized Controlled Trial
Recruiting now · Not applicable
Conditions studied: Mobility Limitation
In brief
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: 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
Key facts
- Study ID
- NCT06245135
- Run by
- University of Toronto
- People needed
- 200
- Starts
- 2024-07-19
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2024-12-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- adult defined as age 18 years or older;
- mobility limitations (eg, need to use a walking aid, difficulty stepping onto curbs, ramps, stairs, or walk on uneven surfaces);
- living independently in the community (in own home or assisted living settings);
- able to walk a minimum of 10 metres independently (with walking aids if used) without assistance and/or supervision from another person;
- able to stand up from and sit down onto a chair independently, without supervision;
- 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;
- 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;
- able to speak and read English to understand informed consent and follow instructions for study procedures and exercises;
You may not qualify if…
- involvement in another formal exercise or rehabilitation program in the next 2 months;
- previous participation in the TIME at Home exercise program;
- health conditions or symptoms preventing participation in exercise;
- cognitive impairment, defined as a score of <11/15 on the 5-minute Montreal Cognitive Assessment (MoCA);
- severe visual impairment;
- severe hearing impairment
- Caregivers
- Inclusion criteria:
- 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;
- able to speak and read English.
- Exclusion criteria:
- Is a paid personal support worker.
Where it is running
- University of Alberta — Edmonton, Alberta, Canada (enrolling)
- University of Manitoba — Winnipeg, Manitoba, Canada (enrolling)
- Bruyère Research Institute — Ottawa, Ontario, Canada (enrolling)
- University of Toronto — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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