Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 26, 2023
Date Accepted: Jun 8, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
eHealth-Based Adaptive Exercise Intervention for Increasing Physical Activity in Persons with Spinal Cord Injury: Study Protocol for a Sequential Multiple Assignment Randomized Trial (SMART)
ABSTRACT
Background:
Participation 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.
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. Two groups of participants will undergo 3-week and 6-week M2M interventions at the first phase. Participants who did not achieve the desired adherence rate (>95% of video watch minutes) will be re-randomized into M2M Live (switch) or individualized behavioral coaching (augmented with the M2M program). The study will primarily assess rates of recruitment/enrollment, adherence and retention, timing to identify non-responders, data completeness, and of outcomes (physical activity, exercise self-efficacy, range of motion). The study will qualitatively evaluate acceptability to the study using semi-structured exit interviews among participants who complete the pilot study.
Results:
Recruitment procedures started on June 22. All data are expected to be collected by April 2023. Full trial results are expected to be published by October 2023. Secondary analyses of data will be subsequently published.
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. Clinical Trial: NCT04726891
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