TIMEâ„¢ at Home Randomized Controlled Trial

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 (TIMEâ„¢ 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 TIMEâ„¢ 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 TIMEâ„¢ 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 TIMEâ„¢ at Home exercise program from their homes using Zoom, or
* to wait 5 months (waitlist control group) before beginning the 8-week TIMEâ„¢ at Home exercise program

Conditions

• Mobility Limitation

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• University Health Network, Toronto

  collaborator OTHER

• March of Dimes, Canada

  collaborator OTHER

• Heart and Stroke Foundation of Canada

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• Bruyère Health Research Institute.

  collaborator OTHER

• University of Toronto

  lead OTHER

Principal Investigators

• Nancy Salbach, PhD · University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-19

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• Canada

Study Locations