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NCT Number: NCT06245135

TIME™ at Home Randomized Controlled 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

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Key information

Conditions

Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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:

  • 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;
  • 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;
  • To assess the cost-effectiveness of the TIME™ at Home program from a societal perspective; and
  • To explore exercise participants', caregivers' and program providers' experiences during the intervention phase.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • able to stand up from and sit down onto a chair independently, without supervision;
  • 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;
  • 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;
  • able to speak and read English to understand informed consent and follow instructions for study procedures and exercises;

Exclusion criteria

  • 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);
  • severe visual impairment;
  • severe hearing impairment

Caregivers

Inclusion criteria

  • 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;
  • able to speak and read English.

Exclusion criteria

  • Is a paid personal support worker.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

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

Secondary outcomes

  1. 7-item Berg balance scale (7BBS)

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Score from 0 to 28 points on 7-item performance-based measure

  2. 30-second sit-to-stand test (30STS)

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Number of stands completed in 30 seconds

  3. Timed 'up and go' (TUG) test

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    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

  4. 3-metre walk test (3mWT, comfortable pace)

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Comfortable walking speed in metres/second based on time taken to walk 3 metres

  5. 3-metre walk test (3mWT, fast pace)

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Fast walking speed in metres/second based on time taken to walk 3 metres

  6. 2-minute step test (2ST)

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Number of times the knee reaches the required height in 2 minutes

  7. Activities-specific balance confidence (ABC) scale

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Score from 0 to 100 points on the 16-item self-report scale

  8. Center for epidemiological studies depression (CES-D) scale

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Score from 0 to 60 points on the 20-item self-report scale

  9. PROMIS v2.0 Social Isolation short form

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Score from 0 to 20 points on the 4-item self-report scale

  10. EuroQoL-5D-5L visual analog scale (EQ-VAS)

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Score from 0 to 100 points on the visual analog scale

  11. Caregiver Assistance Scale (CAS)

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Score from 0 to 102 points on the 17-item self-report scale, completed by caregiver

  12. Center for epidemiological studies depression (CES-D) scale-Caregiver

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Score from 0 to 60 points on the 20-item self-report scale, completed by caregiver

  13. Activities-specific balance confidence (ABC) scale-Caregiver

    Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

    Score from 0 to 100 points on the 16-item self-report scale, completed by caregiver

  14. Program delivery cost

    Time frame: 2 months (immediately post-intervention)

    Cost ($) for community organizations to run the TIME at Home program in the Experimental group

  15. Cost ($) of exercise participation

    Time frame: 2 months (immediately post-intervention)

    Cost ($) for a participant in the Experimental group to participate in the TIME at Home program

  16. Amount ($) willing to pay to register for TIME at Home

    Time frame: 2 months (immediately post-intervention)

    Amount ($) that participants in the Experimental group would be willing to pay out-of-pocket to receive the program

  17. Quality-adjusted life-years (QALYs)

    Time frame: 2 months (immediately post-intervention)

    Scores on the EQ-5D-5L convert to a single index value used to calculate quality-adjusted life-years (QALYs)

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy Salbach, PhD

CONTACT

[email protected]

416-946-8558

Renato Barbosa dos Santos, MSc

CONTACT

[email protected]

416-946-7579

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Bruyère Health Research Institute.
  • Heart and Stroke Foundation of Canada
  • March of Dimes, Canada
  • University Health Network, Toronto
  • University of Alberta
  • University of Manitoba

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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