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Mobility LimitationNCT05369741

TIME™ at Home Feasibility Study: Evaluation of a Virtually Delivered, Community-based, Task-oriented Exercise Program

A study testing TIME™ at Home in people with Mobility Limitation and Balance Impairment, run by University of Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mobility Limitation, Balance Impairment
What is being tested?
TIME™ at Home
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesCanada
Study dates
22 Jan 2022to 31 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Difficulty with balance and mobility;
  • Age ≥ 18 years;
  • Ability to walk a minimum of 10 metres (with walking aids if used) without assistance and supervision from another person;
  • Ability to stand up from and sit down onto a chair independently (without supervision);
  • Ability to maintain balance while exercising in standing (e.g., marching on the spot) holding onto the back of a chair or a sturdy countertop;
  • Ability to speak and read English to understand informed consent and follow instructions for study procedures;
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  • Availability of reliable Internet access at home;
  • Availability of an electronic device (laptop computer, tablet, or smartphone) to view the online exercise classes;
  • Availability of an email address to receive and click on a Zoom link;
  • Access to an armchair or chair of standard height (43-45 cm, 17-18 inches seat height), for the Timed 'Up and Go' test (a performance-based test); and
  • Availability of a caregiver or study partner who can be with the exercise participant for 2 Zoom-based evaluations during which they will be asked a few questions related to their health and will do a test of leg strength and walking
  • Assist the exercise participant to live independently at home by providing help with basic and/or instrumental activities of daily living (doing groceries, cleaning, managing finances, making meals, etc.) at least once a week; and
  • Able to speak and read English

Who cannot join

  • Current or planned involvement in another formal exercise or rehabilitation program for the duration of the study;
  • Conditions or symptoms preventing participation in exercise (e.g., unstable cardiovascular disease, significant back or joint pain);
  • Cognitive impairment, defined by score of <11/15 on 5-minute Montreal Cognitive Assessment (MoCA) - telephone version;
  • Ability to stand on one leg for more than 10 seconds without using any support; and
  • Severe hearing or visual impairment, that would hinder participation and safety in the virtual exercise program, operationalized as follows:
  • I'd like to ask you about your vision. If you were to watch a video with a therapist showing exercises during a Zoom call, would you have any difficulty seeing the therapist, wearing glasses or contact lenses if you use them? If Yes: exclude. If No: pass the screen.
  • I'd like to ask you about your hearing. If you were to watch a video with a therapist showing exercises during a Zoom call, would you have any difficulty hearing the therapist? If Yes: exclude. If No: pass the screen.
  • Paid personal support workers

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • March of Dimes Canada (Halifax)

    Halifax, Nova Scotia, B3L 2C2

  • March of Dimes Canada (Toronto)

    Toronto, Ontario, M5S 1W8

Other trials in Canada

About this study

Official title: Feasibility and Potential Benefits of a Virtually Delivered, Community-based, Task-oriented Exercise Program (TIME™ at Home) for People With Balance and Mobility Limitations

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.

Read the detailed 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).
Being tested
TIME™ at Home
Keywords
Community-based exercise program, Stroke, Multiple Sclerosis, Age-related mobility changes, Brain injury, Virtual exercise program
Medical subject headings
Mobility Limitation, Stroke, Multiple Sclerosis, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIME™ at HomeOther

    Components of each 1.5-hour session:

    1. Pre-class social time (15 min): Unstructured - introductions, safety, and technology troubleshoot, and social interactions if time allows
    2. Exercise video (1 hour pre-recorded): a) 10-minute seated warm up; b) 40-minute functional exercises in standing, with standardized progressions and variations. Exercises are selected from the original, in-person TIME™ program and are deemed safe to perform at home by rehabilitation experts; and c) 10-minute seated cool down
    3. Post-class social time (15 min): Structured and unstructured social interactions
    4. Facilitators: A live virtual facilitator assisted by a co-facilitator to stream video, provide verbal encouragement and technology support
    5. Healthcare partner e-visits: A registered healthcare professional will make 2-3 e-visits. They will observe the class and engage with participants during the post-class social time and debrief with facilitators.
Study groups in NCT05369741
Study groupRoleWhat they receive
TIME™ at HomeExperimentalTIME™ at Home is a licensed, pre-recorded video-based, group, community exercise program. One program will have a maximum of 10 participants registered. March of Dimes Canada will run two programs. A 1.5-hour session will be hosted by two facilitators using Zoom twice a week for 8 weeks, starting with the Level 1 video (beginner level). All participants will switch to the Level 2 video (advanced level) mid-program.
Receives: Other: TIME™ at Home

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Subjective Index of Physical and Social Outcome for exercise participants

    Self-report measure of everyday functioning, scoring range 0-40, higher scores are better.

    Measured: 0 and 8 weeks

Secondary outcomes (14)
  1. Change in Activities-Specific Balance Confidence scale for exercise participants

    Self-report measure of balance self-efficacy, scoring range 0-100, higher scores are better.

    Measured: 0 and 8 weeks

  2. Change in EuroQuol Visual Analogue Scale for exercise participants

    Self-report measure of perceived health status, scoring range 0-100, higher scores are better

    Measured: 0 and 8 weeks

  3. Change in Center for Epidemiological Studies Depression scale for caregiver

    Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

    Measured: 0 week and 8 weeks

  4. Change in 30-second sit to stand test (30STS) for exercise participants

    A performance-based test which measures lower extremity strength and dynamic balance. It is measured by the number of times a person comes to a full standing position from a chair in 30 seconds.

    Measured: 0 and 8 weeks

  5. Change in Timed Up and Go (TUG) test for exercise participants

    A performance-based test which measures functional mobility. The time taken to stand in seconds from a standard chair, walk 3 metres, turn around, return to the chair, and sit down is documented.

    Measured: 0 and 8 weeks

  6. Change in Center for Epidemiological Studies Depression scale for exercise participants

    Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

    Measured: 0 and 8 weeks

  7. Feasibility outcome: adverse events

    0% of the participants will report a serious adverse event, defined as an event that leads to death, a life-threatening adverse event, inpatient hospitalization or a persistent or significant disability or incapacity that lasts more than 48 hours and limits activities of daily living

    Measured: 8 weeks

  8. Feasibility outcome: acceptability of the facilitator

    90% of the participants will report that the facilitator was encouraging

    Measured: 4 and 8 weeks

  9. Feasibility outcome: acceptability of the social component

    60% of the participants will report participating in the social time before and after the exercise video

    Measured: 4 and 8 weeks

  10. Feasibility outcome: acceptability of the healthcare partner

    80% of the participants will report they found the healthcare partner e-visits useful

    Measured: 8 weeks

  11. Feasibility outcome: acceptability of the Level 2 video

    80% of the participants will find the video easy to understand and follow

    Measured: 8 weeks

  12. Feasibility: intervention fidelity

    Checklist completed by a member of the research team

    Measured: Week 5 and 8

  13. Feasibility: Healthcare partner feedback questionnaire

    To describe the program experiences

    Measured: Week 2, 5 and 8

  14. Feasibility outcome: attendance

    70% of the participants will attend at least 75% of the classes (i.e., 12)

    Measured: Each class, i.e. twice a week for eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2022
  2. Study start22 Jan 2022
  3. Primary completion31 Jul 2022
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05369741
Sponsor's protocol ID
41592
Status last verified
May 2023
First submitted
28 Apr 2022
Last updated
18 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barbosa Dos Santos R, Kaur N, Nelson M, Catizzone M, Sheehy L, Munce S, Inness EL, Salbach NM. Feasibility, safety, and potential benefit of a virtual, community-based, task-oriented exercise program (TIMETM at Home) for people with balance and mobility limitations: a pre-post feasibility study. Disabil Rehabil. 2026 Jan;48(2):450-469. doi: 10.1080/09638288.2025.2538757. Epub 2025 Jul 31.

    PubMed 40741863

Questions about this trial

What is this clinical trial studying?

A study testing TIME™ at Home in people with Mobility Limitation and Balance Impairment, run by University of Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Subjective Index of Physical and Social Outcome for exercise participants (time frame: 0 and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05369741, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.

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