Background Wheelchair users live predominantly sedentary lifestyles and have a substantially higher risk for cardiometabolic disease and mortality compared to people without disabilities. Exercise training has been found to be effective in improving cardiometabolic health (CMH) outcomes among people without disabilities, but research on wheelchair users is limited and of poor quality. Objective The primary aim of this study is to examine the immediate and sustained effects of a 24-week, telehealth, movement-to-music cardiovascular (M2M-C) exercise program on core indicators of CMH among adult wheelchair users compared to an active control group. The secondary aim is to explore the beneficial effects of M2M-C exercises on cardiovascular capacity, physical activity, and quality of life. Intervention components include tailored exercises and remote performance monitoring, delivered via live videoconference training by a telecoach and asynchronous videos. Methods This study’s design is a parallel-arm randomized controlled trial enrolling 132 physically inactive adult wheelchair users with poor cardiometabolic profiles. The M2M-C intervention group involves 24 weeks of virtual live and monitored home exercise training (3×/wk, 15-40 min/session), followed by a 12-week maintenance period where participants have access to an online media library of exercise videos. The control group involves 36 weeks of self-guided exercise through access to a media library of exercise videos, including videos for range of motion, muscle strength, and balance. The primary outcomes are cardiometabolic indicators of health, and assessors are blinded. Results Recruitment procedures started in January 2024 with the first participant enrolled on March 18, 2024. All data are anticipated to be collected by November 2027, and the main results of the trial are anticipated to be published by February 2028. Secondary analyses of data will be subsequently published. A total of 16 participants have been recruited as of paper submission. Conclusions The knowledge obtained from this trial will provide evidence to inform exercise prescriptions aimed at improving CMH among adult wheelchair users. Trial Registration ClinicalTrials.gov NCT05606432; https://clinicaltrials.gov/study/NCT05606432 International Registered Report Identifier (IRRID) DERR1-10.2196/57423
BACKGROUND:Participating in an adequate amount of physical activity to acquire health benefits is challenging for people with spinal cord injury (SCI) due to personal and logistic barriers. Barriers in the built and social environments may include lack of transportation, lack of accessible facilities or programs, and lack of training among fitness personnel. Low self-efficacy, lack of self-regulation skills, and improper outcome expectations are examples of personal barriers. Current approaches to investigating physical activity programs in people with SCI have been limited to traditional "one-size-fits-all" design, which has yielded low adherence rates, high dropout rates, and participants not maintaining physical activity levels at follow-up.OBJECTIVE:The primary aim of this study is to test the feasibility of a tele-exercise program that applies an adaptive intervention design for 30 adults with SCI, targeting increases in adherence to the exercise program and physical activity participation.METHODS:The Sequential Multiple Assignment Randomized Trial for Home-based Exercise and Lifestyle Tele-Health (SMART-HEALTH) is a 12-week, home-based, movement-to-music (M2M) program. The goal of a SMART-designed study is to develop an adaptive intervention that modifies support provisions based on response levels. In SMART-HEALTH, 2 groups of participants will undergo 3-week and 6-week asynchronous M2M interventions in the first phase. Participants who did not achieve the desired adherence rate (≥95% of video watch minutes) will be rerandomized into M2M Live (switch) or individualized behavioral coaching (augmented with the asynchronous M2M program). The study will primarily assess rates of recruitment or enrollment, adherence and retention, timing to identify nonresponders, and scientific outcomes (eg, physical activity and exercise self-efficacy). The study will qualitatively evaluate the acceptability of the study using semistructured interviews among participants who complete the 12-week intervention.RESULTS:Recruitment procedures started in June 2022. All data are expected to be collected by September 2023. Full trial results are expected to be published by March 2024. Secondary analyses of data will be subsequently published. Results will include exercise adherence rates; changes in self-reported physical activity levels and blood pressure; and changes in secondary conditions including pain, sleep, and fatigue. Thematic analysis of semistructured interviews will include results on participant enjoyment and acceptability of SMART-HEALTH and inform modifications for future delivery of the program.CONCLUSIONS:This study will strengthen our understanding of the potential benefits of the tele-exercise intervention for people with SCI and build upon adaptive intervention design and its delivery strategies that aim to increase adoption and sustainable exercise behavior. This pilot trial will inform future SMART-designed studies and provide new and innovative strategies for investigating intervention effects on physical activity behavior in the SCI population.TRIAL REGISTRATION:ClinicalTrials.gov NCT04726891; https://classic.clinicaltrials.gov/ct2/show/NCT04726891.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/47665.
Background The Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) initiative is a large randomized controlled study that aims to overcome logistical barriers to exercise via telehealth for people with physical disabilities. However, at the start of the COVID-19 pandemic, enrollment was halted due to limited operations at the testing site, which included no onsite visits that involved participant data collection. In response to the limited operations, a modified data collection protocol was developed for virtual enrollment of study participants. Objective This paper presents feasibility data on using teleassessments to enroll people with mobility impairment into a home-based exercise trial. Methods The modified protocol replaced onsite enrollment and data collection visits with teleassessments using a computer tablet and testing equipment that was shipped to the participants’ home address prior to the synchronous teleassessments conducted by an exercise physiologist through Zoom. The participants were mailed a teleassessment toolkit that included a digital blood pressure cuff, spirometer, hand dynamometer, mini disc cone, and measuring tape (to complete standardized testing). The teleassessment measures included resting blood pressure and heart rate, forced vital capacity, grip strength, Five Times Sit to Stand, and Timed Up and Go. Feasibility metrics included technological effectiveness, efficiency, and safety. The technological effectiveness of the telehealth assessment was determined by the percentage of sessions completed without technical issues with ≥90% criteria set a priori. Efficiency was measured by a session duration of ≤2 hours. Safety was measured by the number of adverse events related to the teleassessments reported. Results Data from 36 participants were included in this feasibility study, and 34 (94%) participants completed all teleassessments without technical issues. For efficiency, the teleassessment sessions were completed in a mean time of 65 minutes and a maximum session length of 110 minutes. There were no adverse events reported to indicate concerns with the safety of teleassessments. Conclusions The modified teleassessment protocol, in response to COVID-19 restrictions, may be a feasible process for enrolling adults with mobility impairment into a home exercise trial who otherwise would have not been able to participate. Trial Registration ClinicalTrials.gov NCT03024320; https://clinicaltrials.gov/ct2/show/NCT03024320