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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

TIME at Home
Behavioral
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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: TIME at HomeExperimental treatment 1 intervention

Group B: WaitlistNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months

Score from 0 to 20 points, 5-item self-report scale measuring everyday functioning

Time frame