Clinical trial NCT06245135: TIME™ at Home Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mobility Limitation
Keywords: Virtual Exercise
Community-based Exercise
Mobility
Balance
Randomized Controlled Trial
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: March of Dimes, Canada
name: Heart and Stroke Foundation of Canada
name: University of Alberta
name: University of Manitoba
name: Bruyere Research Institute
First posted: 2024-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary outcomes:
measure: 7-item Berg balance scale (7BBS)
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: 30-second sit-to-stand test (30STS)
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: Timed 'up and go' (TUG) test
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: 3-metre walk test (3mWT, comfortable pace)
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: 3-metre walk test (3mWT, fast pace)
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: 2-minute step test (2ST)
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: Activities-specific balance confidence (ABC) scale
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: Center for epidemiological studies depression (CES-D) scale
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: PROMIS v2.0 Social Isolation short form
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: EuroQoL-5D-5L visual analog scale (EQ-VAS)
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: Caregiver Assistance Scale (CAS)
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: Center for epidemiological studies depression (CES-D) scale-Caregiver
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: Activities-specific balance confidence (ABC) scale-Caregiver
timeFrame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
measure: Program delivery cost
timeFrame: 2 months (immediately post-intervention)
measure: Cost ($) of exercise participation
timeFrame: 2 months (immediately post-intervention)
measure: Amount ($) willing to pay to register for TIME at Home
timeFrame: 2 months (immediately post-intervention)
measure: Quality-adjusted life-years (QALYs)
timeFrame: 2 months (immediately post-intervention)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Ottawa
country: Canada
facility: Bruyère Research Institute
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Nancy Salbach, PhD
role: PRINCIPAL_INVESTIGATOR
References: