Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06245135

TIME™ at Home Randomized Controlled Trial

Led by University of Toronto · Updated on 2024-12-30

200

Participants Needed

4

Research Sites

84 weeks

Total Duration

On this page

Sponsors

U

University of Toronto

Lead Sponsor

U

University Health Network, Toronto

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

TIME™ at Home Randomized Controlled Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Have mobility limitations such as needing a walking aid or difficulty stepping onto curbs, ramps, stairs, or uneven surfaces
  • Living independently in the community, either in own home or assisted living
  • Able to walk at least 10 metres independently, with or without walking aids, without help 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 by holding onto a chair or sturdy countertop
  • Have a study partner (caregiver, family member, or friend) willing to be present at the first evaluation via Zoom
  • Able to speak and read English to understand consent and follow study instructions
  • Caregiver must provide support with at least one basic or instrumental daily living activity weekly
  • Caregiver able to speak and read English
Not Eligible

You will not qualify if you...

  • Currently involved in another formal exercise or rehabilitation program within the next 2 months
  • Previously participated in the TIME at Home exercise program
  • Have health conditions or symptoms that prevent exercise participation
  • Cognitive impairment with a score below 11 out of 15 on the 5-minute Montreal Cognitive Assessment (MoCA)
  • Severe visual impairment
  • Severe hearing impairment
  • Caregiver is a paid personal support worker

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

University of Alberta

Edmonton, Alberta, Canada, T6G 2G5

Actively Recruiting

2

University of Manitoba

Winnipeg, Manitoba, Canada, R3E 0T6

Actively Recruiting

3

Bruyère Research Institute

Ottawa, Ontario, Canada, K1N 5C8

Actively Recruiting

4

University of Toronto

Toronto, Ontario, Canada, M5G 1V7

Actively Recruiting

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Research Team

R

Renato Barbosa dos Santos, MSc

CONTACT

N

Nancy Salbach, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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