TIME™ at Home Randomized Controlled Trial (NCT06245135)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (9 items).
Location: University of Alberta — Edmonton, Alberta
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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: 1\. Is a paid personal support worker.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- University of Alberta — Edmonton, Alberta
- University of Manitoba — Winnipeg, Manitoba
- Bruyère Research Institute — Ottawa, Ontario
- University of Toronto — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.