TIME™ at Home Randomized Controlled Trial
ConditionMobility Limitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Toronto
About this trial
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
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- TIME at Home
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Toronto
Lead sponsor
University Health Network, Toronto
Collaborator
March of Dimes, Canada
Collaborator
Heart and Stroke Foundation of Canada
Collaborator
University of Alberta
Collaborator
University of Manitoba
Collaborator
Bruyère Health Research Institute.
Collaborator
Source ClinicalTrials.gov