TIME™ at Home Randomized Controlled Trial

Mobility Limitation Clinical Trial

Official title: 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

Status Not yet recruiting

Clinical 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 (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

Clinical Trial Description

Mobility limitations are highly prevalent, limit everyday functioning, and increase the need for caregiver assistance in people with chronic health conditions, such as stroke, and multiple sclerosis. While community exercise programs have been shown to improve physical and mental health, older adults with mobility limitations face numerous challenges with attending in-person community exercise programs. Challenges relate to the availability and cost of transportation, inclement weather, inadequate building access, program cost, risk of infection, and pandemic-related program closures. In addition, caregivers commonly need to provide transportation, which can take time away from paid employment and other daily activities. Some recreation centres do not have the funding to operate exercise programs for people with balance and mobility limitations that require instructors with specialized skills and a high level of exercise supervision.

The objectives of the TIME™ at Home randomized controlled trial are:

1. To estimate the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) compared to a waitlist control on improving everyday function (primary outcome), mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, and caregiver confidence in care-recipient balance (secondary outcomes) in community-dwelling adults with mobility limitations;

2. To determine whether level of mobility limitation, sex, or gender, modifies the effect of the TIME™ at Home program compared to a waitlist control in improving everyday function;

3. To assess the cost-effectiveness of the TIME™ at Home program from a societal perspective; and

4. To explore exercise participants', caregivers' and program providers' experiences during the intervention phase. ;

Related Conditions & MeSH terms

• Mobility Limitation

• NCT number: NCT06245135
• Study type: Interventional
• Source: University of Toronto
• Contact: Michelle Legasto-Mulvale, MSc
• Phone: 416-946-7579
• Email: timestudy@utoronto.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Completion date: March 2026