NCT06245135 TIME™ at Home Randomized Controlled Trial
| NCT ID | NCT06245135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Toronto |
| Condition | Mobility Limitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-07-19 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. adult defined as age 18 years or older; 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; Exclusion Criteria: 1. involvement in another formal exercise or rehabilitation program in the next 2 months; 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 Inclusion criteria: 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: 1\. Is a paid personal support worker.
Contact & Investigator
Nancy Salbach, PhD
PRINCIPAL INVESTIGATOR
University of Toronto
Frequently Asked Questions
Who can join the NCT06245135 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mobility Limitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06245135 currently recruiting?
Yes, NCT06245135 is actively recruiting participants. Contact the research team at timestudy@utoronto.ca for enrollment information.
Where is the NCT06245135 trial being conducted?
This trial is being conducted at Edmonton, Canada, Winnipeg, Canada, Ottawa, Canada, Toronto, Canada.
Who is sponsoring the NCT06245135 clinical trial?
NCT06245135 is sponsored by University of Toronto. The principal investigator is Nancy Salbach, PhD at University of Toronto. The trial plans to enroll 200 participants.