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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245135
• Other study ID #: 45343
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: University of Toronto
• Contact: Michelle Legasto-Mulvale, MSc
• Phone: 416-946-7579
• Email: timestudy[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
University of Toronto	Bruyere Research Institute, Heart and Stroke Foundation of Canada, March of Dimes, Canada, University Health Network, Toronto, University of Alberta, University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	7-item Berg balance scale (7BBS)	Score from 0 to 28 points on 7-item performance-based measure	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	30-second sit-to-stand test (30STS)	Number of stands completed in 30 seconds	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	Timed 'up and go' (TUG) test	Time in seconds, taken to stand up from a standard armchair, walk a distance of 3 metres, turn around, walk back to the chair, and sit down again	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	3-metre walk test (3mWT, comfortable pace)	Comfortable walking speed in metres/second based on time taken to walk 3 metres	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	3-metre walk test (3mWT, fast pace)	Fast walking speed in metres/second based on time taken to walk 3 metres	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	2-minute step test (2ST)	Number of times the knee reaches the required height in 2 minutes	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	Activities-specific balance confidence (ABC) scale	Score from 0 to 100 points on the 16-item self-report scale	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	Center for epidemiological studies depression (CES-D) scale	Score from 0 to 60 points on the 20-item self-report scale	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	PROMIS v2.0 Social Isolation short form	Score from 0 to 20 points on the 4-item self-report scale	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	EuroQoL-5D-5L visual analog scale (EQ-VAS)	Score from 0 to 100 points on the visual analog scale	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	Caregiver Assistance Scale (CAS)	Score from 0 to 102 points on the 17-item self-report scale, completed by caregiver	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	Center for epidemiological studies depression (CES-D) scale-Caregiver	Score from 0 to 60 points on the 20-item self-report scale, completed by caregiver	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	Activities-specific balance confidence (ABC) scale-Caregiver	Score from 0 to 100 points on the 16-item self-report scale, completed by caregiver	0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary	Program delivery cost	Cost ($) for community organizations to run the TIME at Home program in the Experimental group	2 months (immediately post-intervention)
Secondary	Cost ($) of exercise participation	Cost ($) for a participant in the Experimental group to participate in the TIME at Home program	2 months (immediately post-intervention)
Secondary	Amount ($) willing to pay to register for TIME at Home	Amount ($) that participants in the Experimental group would be willing to pay out-of-pocket to receive the program	2 months (immediately post-intervention)
Secondary	Quality-adjusted life-years (QALYs)	Scores on the EQ-5D-5L convert to a single index value used to calculate quality-adjusted life-years (QALYs)	2 months (immediately post-intervention)