Recruiting

TIME™

Sponsor:

University of Toronto

Code:

NCT06245135

Conditions

Mobility Limitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TIME at Home

Study Details

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

Conditions

Mobility Limitation

Study ID

NCT06245135

Start date

Jul 19, 2024

Status verified date

Dec, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TIME at Home

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.

no intervention: Waitlist

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

Interventions

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Renato Barbosa dos Santos, MSc

416-946-7579timestudy@utoronto.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2G5

Contacts

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0T6

Contacts

Bruyère Research Institute

Recruiting

Ottawa, Ontario, Canada, K1N 5C8

Contacts

University of Toronto

Recruiting

Toronto, Ontario, Canada, M5G 1V7

Contacts

Renato Barbosa dos Santos, MSc

(416) 946-7579timestudy@utoronto.ca

Principal Investigator:

Nancy Salbach, PhD

More Information

Sponsor

University of Toronto

Last update posted

Dec 30, 2024

Last verified

Dec, 2024

Keywords

  • Virtual Exercise
  • Community-based Exercise
  • Mobility
  • Balance
  • Randomized Controlled Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2024-12-30.