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

NCT05369741 | Completed

• 1 other identifier: 41592
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mobility Limitation; Balance Impairment

Keywords

Community-based exercise program; Stroke; Multiple Sclerosis; Age-related mobility changes; Brain injury; Virtual exercise program

Outcome Measures

Primary Outcomes (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.

  0 and 8 weeks

Secondary Outcomes (14)

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

  0 and 8 weeks

• Change in EuroQuol Visual Analogue Scale for exercise participants

  0 and 8 weeks

• Change in Center for Epidemiological Studies Depression scale for caregiver

  0 week and 8 weeks

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

  0 and 8 weeks

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

  0 and 8 weeks

Study Arms (1)

TIME™ at Home

EXPERIMENTAL

TIME™ 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.

Other: TIME™ at Home

Interventions

TIME™ at Home OTHER

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.

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:

• 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

You may not qualify if:

• 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.
• 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
• Paid personal support workers

Sponsors & Collaborators

• University of Toronto: lead
• March of Dimes, Canada: collaborator

Study Sites (2)

March of Dimes Canada (Halifax)

Halifax, Nova Scotia, B3L 2C2, Canada

Location

March of Dimes Canada (Toronto)

Toronto, Ontario, M5S 1W8, Canada

Location

Related Publications (1)

• 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. 2025 Jul 31:1-20. doi: 10.1080/09638288.2025.2538757. Online ahead of print.

  PMID: 40741863 DERIVED

MeSH Terms

Conditions

Mobility Limitation; Stroke; Multiple Sclerosis; Brain Injuries

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Nancy Salbach, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physical Therapy, Rehabilitation Sciences Institute

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 11, 2022
• Study Start: January 22, 2022
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)