TIME™ at Home Randomized Controlled Trial

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

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

Study Overview

• Status: Recruiting
• Conditions: Mobility Limitation
• Intervention / Treatment: Behavioral: TIME at Home

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy Salbach, PhD; Phone Number: 416-946-8558; Email: nancy.salbach@utoronto.ca
• Study Contact Backup: Name: Renato Barbosa dos Santos, MSc; Phone Number: 416-946-7579; Email: timestudy@utoronto.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G5
      • Recruiting
      • University of Alberta
      • Contact: Doyeon Hwang, MScPH; Phone Number: (825) 975-4800; Email: rehab.timestudy@ualberta.ca
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0T6
      • Recruiting
      • University of Manitoba
      • Contact: Roheema Ewesesan, MD; Phone Number: (204) 787-8015; Email: Roheema.Ewesesan@umanitoba.ca
  • Ontario
    • Ottawa, Ontario, Canada, K1N 5C8
      • Recruiting
      • Bruyere Research Institute
      • Contact: Asefeh Memarian, MSc; Phone Number: (613) 562-6262 ext. 1419; Email: amemarian@bruyere.org
    • Toronto, Ontario, Canada, M5G 1V7
      • Recruiting
      • University of Toronto
      • Contact: Renato Barbosa dos Santos, MSc; Phone Number: (416) 946-7579; Email: timestudy@utoronto.ca
      • Principal Investigator: Nancy Salbach, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: Waitlist; Individuals in the waitlist control group will receive the TIME at Home program following the final 5-month evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Program delivery cost	Cost ($) for community organizations to run the TIME at Home program in the Experimental group	2 months (immediately post-intervention)
Cost ($) of exercise participation	Cost ($) for a participant in the Experimental group to participate in the TIME at Home program	2 months (immediately post-intervention)
Amount ($) 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)
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)

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: University of Manitoba; University Health Network, Toronto; University of Alberta; Heart and Stroke Foundation of Canada; Bruyere Research Institute; March of Dimes, Canada
• Investigators: Principal Investigator: Nancy Salbach, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Balance; Randomized Controlled Trial; Mobility; Virtual Exercise; Community-based Exercise
• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: 45343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The anonymized data collected during the study, the trial protocol, statistical analysis plan, and informed consent form, will be shared with qualified researchers engaging in REB-approved independent scientific research, upon request to the research team.
• IPD Sharing Time Frame: After the study ends.
• IPD Sharing Access Criteria: Please contact the research team
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No