TIME™ at Home Randomized Controlled Trial

NCT06245135 | Recruiting DMC

• 1 other identifier: 45343
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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:

• 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 7-item Berg balance scale (7BBS)

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

• 30-second sit-to-stand test (30STS)

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

• Timed 'up and go' (TUG) test

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

• 3-metre walk test (3mWT, comfortable pace)

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

• 3-metre walk test (3mWT, fast pace)

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

Study Arms (2)

TIME at Home

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

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

Interventions

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.

TIME at Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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
• 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.
• \. Is a paid personal support worker.

Sponsors & Collaborators

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

Study Sites (4)

University of Alberta

Edmonton, Alberta, T6G 2G5, Canada

RECRUITING

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

RECRUITING

Bruyère Research Institute

Ottawa, Ontario, K1N 5C8, Canada

RECRUITING

University of Toronto

Toronto, Ontario, M5G 1V7, Canada

RECRUITING

Related Publications (1)

• Salbach NM, Jones CA, Barclay R, Sveistrup H, Sheehy L, Bayley MT, Inness EL, Legasto-Mulvale JM, Barbosa Dos Santos R, Fung J, Moineddin R, Teasell RW, Catizzone M, Hovanec N, Cameron JI, Munce S, O'Neil J, Jaglal SB, Aravind G, Su TT, Hanson HM. Short-term effects of a virtual, community-based, task-oriented group exercise programme incorporating a healthcare-community partnership compared to a waitlist control on increasing everyday function among adults with mobility limitations: protocol for the TIME at Home randomised controlled trial. BMJ Open. 2025 Jul 28;15(7):e102694. doi: 10.1136/bmjopen-2025-102694.

  PMID: 40721264 DERIVED

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy Salbach, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renato Barbosa dos Santos, MSc

CONTACT

416-946-7579; timestudy@utoronto.ca

Nancy Salbach, PhD

CONTACT

416-946-8558; nancy.salbach@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single: Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel assignment

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 7, 2024
• Study Start: July 19, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study ends.
• Access Criteria: Please contact the research team

Locations

CA (4)