TIME™ at Home Randomized Controlled Trial
Short-term Effects of a Virtual, Community-based, Task-oriented Group Exercise Program Compared to a Waitlist Control in Increasing Function Among Adults With Balance and Mobility Limitations: The TIME™ at Home Randomized Controlled Trial
University of Toronto
200 participants
Jul 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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;
- 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 Criteria8
- 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
- \. Is a paid personal support worker.
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Interventions
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.
Locations(4)
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NCT06245135