TIME™ at Home Feasibility Study: Evaluation of a Virtually Delivered,

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

CompletedNot a drug-phase studyMS (type not specified)NCT05369741

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • TIME™ at Home

What it measured

Main measures

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

    0 and 8 weeks

    Physical function

Other measures (14)

  • Change in Activities-Specific Balance Confidence scale for exercise participants

    0 and 8 weeks

    Walking and mobilityPhysical function

  • Change in EuroQuol Visual Analogue Scale for exercise participants

    0 and 8 weeks

    Physical function

  • Change in Center for Epidemiological Studies Depression scale for caregiver

    0 week and 8 weeks

    Mood and sleep

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

    0 and 8 weeks

    Walking and mobilityPhysical function

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

    0 and 8 weeks

    Walking and mobilityPhysical function

  • Change in Center for Epidemiological Studies Depression scale for exercise participants

    0 and 8 weeks

    Physical functionMood and sleep

  • Feasibility outcome: adverse events

    8 weeks

    SafetyFeasibility

  • Feasibility outcome: acceptability of the facilitator

    4 and 8 weeks

    Feasibility

  • Feasibility outcome: acceptability of the social component

    4 and 8 weeks

    Physical functionFeasibility

  • Feasibility outcome: acceptability of the healthcare partner

    8 weeks

    Feasibility

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

Inclusion Criteria for Exercise Participants (Self-report): * 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; * 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 Exclusion Criteria for Exercise Participants: * 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: 1. 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. 2. 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. Inclusion Criteria for Caregivers: * 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 Exclusion Criteria for Caregivers: • Paid personal support workers

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jan 2022

    2. Main results due

      Jul 2022

    3. Finished

      Jul 2022

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