TIME™ at Home Randomized Controlled Trial

Official title

Short-term Effects of a Virtual, Community-based, Task-oriented Group Exercise Program Compared to a Waitlist Control in Increasing Function Among Adults With Balance and Mobility Limitations: The TIME™ at Home Randomized Controlled Trial

Overview

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

Detailed description

Mobility limitations are highly prevalent, limit everyday functioning, and increase the need for caregiver assistance in people with chronic health conditions, such as stroke, and multiple sclerosis. While community exercise programs have been shown to improve physical and mental health, older adults with mobility limitations face numerous challenges with attending in-person community exercise programs. Challenges relate to the availability and cost of transportation, inclement weather, inadequate building access, program cost, risk of infection, and pandemic-related program closures. In addition, caregivers commonly need to provide transportation, which can take time away from paid employment and other daily activities. Some recreation centres do not have the funding to operate exercise programs for people with balance and mobility limitations that require instructors with specialized skills and a high level of exercise supervision.

The objectives of the TIME™ at Home randomized controlled trial are:

1. To estimate the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) compared to a waitlist control on improving everyday function (primary outcome), mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, and caregiver confidence in care-recipient balance (secondary outcomes) in community-dwelling adults with mobility limitations; 2. To determine whether level of mobility limitation, sex, or gender, modifies the effect of the TIME™ at Home program compared to a waitlist control in improving everyday function; 3. To assess the cost-effectiveness of the TIME™ at Home program from a societal perspective; and 4. To explore exercise participants', caregivers' and program providers' experiences during the intervention phase.

Interventions

• Behavioral TIME at Home
  Sessions involve a 15-minute pre-video safety check and social time; streaming a 1-hour pre-recorded exercise video; and a 15-minute post-video social time. Two trained facilitators run each class, with a maximum group size of 10 people. The 1-hour exercise videos include a seated warm-up and cooldown, and 40 minutes of functional, self-paced exercises. In the video, 2 healthcare professionals demonstrate a lower and higher difficulty level of each exercise. The program starts with a level 1 vi

Primary outcome measures

• Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]

Secondary outcome measures (12)

• 7-item Berg balance scale (7BBS) [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• 30-second sit-to-stand test (30STS) [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• Timed 'up and go' (TUG) test [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• 3-metre walk test (3mWT, comfortable pace) [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• 3-metre walk test (3mWT, fast pace) [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• 2-minute step test (2ST) [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• Activities-specific balance confidence (ABC) scale [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• Center for epidemiological studies depression (CES-D) scale [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• PROMIS v2.0 Social Isolation short form [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• EuroQoL-5D-5L visual analog scale (EQ-VAS) [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• Caregiver Assistance Scale (CAS) [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]
• Center for epidemiological studies depression (CES-D) scale-Caregiver [Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)]

Eligibility criteria

Inclusion criteria

• adult defined as age 18 years or older;
• mobility limitations (eg, need to use a walking aid, difficulty stepping onto curbs, ramps, stairs, or walk on uneven surfaces);
• living independently in the community (in own home or assisted living settings);
• able to walk a minimum of 10 metres independently (with walking aids if used) without assistance and/or supervision 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 (e.g., marching on the spot) holding onto the back of a chair or a sturdy countertop;
• has a study partner (e.g., caregiver, family member or friend) willing to be present, at minimum, during the first evaluation in the home via Zoom;
• able to speak and read English to understand informed consent and follow instructions for study procedures and exercises;

Exclusion criteria

• involvement in another formal exercise or rehabilitation program in the next 2 months;
• previous participation in the TIME at Home exercise program;
• health conditions or symptoms preventing participation in exercise;
• cognitive impairment, defined as a score of <11/15 on the 5-minute Montreal Cognitive Assessment (MoCA);
• severe visual impairment;
• severe hearing impairment

Caregivers

Inclusion criteria

• caregiver defined as an individual who helps the exercise participant to live at home by providing support and assistance with at least one basic (e.g., self-care) and/or instrumental activity of daily living (e.g., doing groceries, cleaning, managing finances, making meals, doing laundry, etc.) at least once a week;
• able to speak and read English.

Exclusion criteria

1\. Is a paid personal support worker.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 4 centers

• University of Alberta — Edmonton
• University of Manitoba — Winnipeg
• Bruyère Research Institute — Ottawa
• University of Toronto — Toronto

Publications

• Salbach NM, Jones CA, Barclay R, Sveistrup H, Sheehy L, Bayley MT, Inness EL, Legasto-Mulvale JM, Barbosa Dos Santos R, Fung J, Moineddin R, Teasell RW, Catizzone M, Hovanec N, Cameron JI, Munce S, O'Neil J, Jaglal SB, Aravind G, Su TT, Hanson HM. Short-term effects of a virtual, community-based, task-oriented group exercise programme incorporating a healthcare-community partnership compared to a PMID 40721264

Identifiers

NCT: NCT06245135 · 45343

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗