Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05369741 |
Other study ID # |
41592 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 22, 2022 |
Est. completion date |
July 31, 2022 |
Study information
Verified date |
May 2023 |
Source |
University of Toronto |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Balance and mobility limitations can lead to increased difficulty with everyday function and
increased dependence on caregivers. Adults with balance and mobility limitations need access
to safe and beneficial exercise programs to maintain or improve their health. Task-oriented
exercise programs designed for adults with balance and mobility limitations incorporating a
healthcare-community partnership, are safe and feasible to implement in the community
setting. In this model, trained fitness instructors deliver the exercise program, and a
registered healthcare professional in a healthcare partner role provides ongoing support
through class visits, email communication with instructors, and program referrals. One
example is Together in Movement and Exercise (TIME™) program which was developed by physical
therapists at the Toronto Rehabilitation Institute, University Health Network (TRI-UHN).
Research has shown that the in-person TIME™ program has the potential to improve everyday
function, independence, and social participation in people with neurological conditions.
Virtual delivery of these programs is needed to address barriers to attending in-person
exercise programs. Barriers can include inadequate access to transportation, inclement
weather, distance to community centres, and community centre closures during pandemic
situations.
This is a before-and-after study to evaluate the potential benefit, safety, and feasibility
of the virtual TIME™ program (called at TIME™ at Home), delivered using a group-based, 8-week
program format, among people with balance and mobility limitations. Also, the aim is to
describe the experiences of participants, caregivers, healthcare partners, and program
facilitators and coordinators with the program to make recommendations for improvement.
Description:
Balance and mobility limitations can adversely affect everyday functioning and accelerate
dependence on caregivers leading to institutionalization. Previous literature has suggested
that a group, task-oriented community-based exercise program (CBEP), targeting balance and
mobility (i.e., capacity for walking, transfers, sit-to-stand, stairs), implemented through
an innovative healthcare-community partnership (CBEP-HCP), has the potential to improve
everyday function, independence and social participation in persons with stroke. The Together
in Movement and Exercise (TIME™) program is a licensed, group, task-oriented community-based
exercise program incorporating a healthcare-community partnership for adults with balance and
mobility limitations. Physical therapists at the Toronto Rehabilitation Institute, University
Health Network (TRI-UHN), developed the TIME™ program. Trained fitness instructors deliver
the exercise program face-to-face (in-person) in community centres and a healthcare
professional who serves as a healthcare partner provides ongoing support. The program has
been offered in over 50 community centres across Canada.
Virtual delivery of CBEP-HCPs is needed to address barriers to attending in-person exercise
programs among people with balance and mobility limitations. Barriers can include inadequate
access to transportation, inclement weather, distance to community centres, and community
centre closures during pandemic situations.
During the COVID-19 pandemic, the investigators used an iterative process to develop an
online version of the TIME™ program, called TIME™ at Home. TIME™ at Home is a standardized,
community-based program licensed by the UHN involving the delivery of video-based
task-oriented exercises. The exercises in the video were adapted from the classic in-person
TIME™ program and were considered safe for people with balance and mobility limitations to
perform at home. In addition to a warm-up and cool-down, the video shows a physical therapist
and an occupational therapist performing each exercise at two difficulty levels. Participants
are asked to self-pace and self-select the difficulty level that feels right for them. A
trained facilitator at a community organization streams the video for people with balance and
mobility limitations using Zoom.
The TIME™ at Home program, due to its virtual nature, has potential to improve exercise
participation in remote and isolated settings. Unlike the in-person program, it does not
require participants to be physically present at a community centre, thus eliminating some
common barriers like lack of (adaptive) transportation, difficulty with transportation during
inclement weather, long travel times to community centres from rural settings, and inadequate
building access. The program can be delivered at home with minimal equipment. Also, the
program involves showing standardized exercise videos developed by physical therapists and
occupational therapists at TRI-UHN which prevents the need to train fitness instructors to
deliver the program. Therefore, TIME™ at Home has potential for reducing barriers encountered
with delivering in-person standardized exercise programs in community-based settings.
Pilot research to date on the TIME™ at Home Program (Virtual Program)
Program developers at TRI-UHN in collaboration with our research group have evaluated the
feasibility of components of the virtual TIME™ at Home Program in partnership with the
Multiple Sclerosis Society of Canada and Abilities Centre in Whitby (Ontario). Findings
support the safety of delivering TIME™ at Home using a drop-in format. The safety,
feasibility, and potential benefit of a group-based format, class visits from a healthcare
partner, and a post-class social time to facilitate social support, have not been
comprehensively evaluated.
Thus, the study objectives are:
1. To evaluate the feasibility, safety, and potential to improve everyday functioning,
lower extremity strength, functional mobility, balance self-efficacy, mood, caregiver
mood, and perceived health status, of an 8-week, group, virtual, task-oriented community
exercise program called TIME™ at Home, among people with balance and mobility
limitations.
2. To describe the experiences of exercise participants, caregivers, healthcare partners,
and program facilitators and coordinators with TIME™ at Home (using qualitative data
collection and analyses).