TIME™ at Home Randomized Controlled Trial

NCT06245135 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Toronto

Phase

Not applicable

Started

2024-07-19

Last updated

2024-12-30

Condition(s) studied

Mobility Limitation

Investigational drug(s) / intervention(s)

TIME at Home

TIME at Home: 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months — 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Score from 0 to 20 points, 5-item self-report scale measuring everyday functioning

Trial sites (4)

Facility	City	Region	Status
University of Alberta	Edmonton	Alberta	Recruiting
University of Manitoba	Winnipeg	Manitoba	Recruiting
Bruyère Research Institute	Ottawa	Ontario	Recruiting
University of Toronto	Toronto	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06245135 on ClinicalTrials.gov ↗ ← All trials in Canada