Clinical Trial

TIME™ at Home Randomized Controlled Trial

Recruiting
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Record status
This record was last updated December 30, 2024 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-01-29; most recent amendment 2024-12-24.
Status change: Not Yet Recruiting → Recruiting 2024-08-02
Trial Details
NCT Number NCT06245135
Lead Sponsor University of Toronto
Collaborators: University Health Network, Toronto, March of Dimes, Canada, Heart and Stroke Foundation of Canada, University of Alberta, University of Manitoba, Bruyère Health Research Institute.
Conditions Mobility Limitation
Enrollment 200 participants
Start Date 2024-07-19
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2024-12-30