TIME™ at Home Randomized Controlled Trial

University of Toronto

Status: Enrolling

Conditions: Mobility Limitation

Treatments: Behavioral: TIME at Home

Study type: Interventional

Funder types: Other

Identifiers

NCT06245135

45343

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

TIME at Home

Experimental group

Description:

TIME at Home is a virtual, group, task-oriented exercise program targeting balance and mobility. A community organization delivers two 1.5-hour sessions per week, for 8 weeks using Zoom.

Treatment:

Behavioral: TIME at Home

Waitlist

No Intervention group

Description:

Individuals in the waitlist control group will receive the TIME at Home program following the final 5-month evaluation.