Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 1, 2023
Date Accepted: Mar 11, 2023
Feasibility, Usability and Safety of ParaGym, an Intelligent Mobile Exercise App for Individuals with Paraplegia: Protocol of a Pilot Block-Randomized Controlled Trial
ABSTRACT
Background:
Digital health apps are a promising opportunity to promote a healthy lifestyle and autonomy for individuals with paraplegia. Personalization to the user’s individual needs is considered a crucial feature of mobile fitness apps in general but even more for individuals with disabilities. The ParaGym mobile fitness app prototype has been designed to automatically tailor exercise sessions to the individual needs of users with paraplegia.
Objective:
The objective of this study is to evaluate the feasibility, usability, safety, and preliminary effectiveness of the ParaGym mobile exercise app prototype.
Methods:
The pilot block-randomized controlled feasibility trial will include 45 adult participants with paraplegia. Eligible participants will be block-randomized to intervention and waitlist-control groups, stratified by lesion level and completeness. Participants allocated to the intervention group will perform a 6-week exercise program using the ParaGym mobile exercise app, comprising three 35-minute exercise sessions per week. The waitlist-control group will continue their usual care and receive access to the app after study completion. All exercise sessions of both groups during the study period will be recorded by the participants using exercise diaries. Primary outcomes include feasibility, which will be assessed using semi-structured interviews, study adherence and retention rates, usability measured via the System Usability Scale (SUS) and safety determined as the occurrence of adverse events. Secondary outcomes include the effects of the intervention on peak exercise capacity (VO2peak), handgrip strength, independence using the Spinal Cord Independence Measure (SCIM), and health-related quality of life using the Short Form-36 Health Survey (SF-36).
Results:
Recruitment commenced in November 2022. 12 participants were already enrolled at the time of submission. Data collection commenced in January 2023 with expected completion in April 2023.
Conclusions:
To the best of our knowledge, this is the first study to assess the feasibility, usability, and safety of an intelligent mobile exercise app for individuals with paraplegia. Such an intelligent exercise app has the potential to increase access to personalized, independent, and evidence-based exercise training for this cohort and, in the future, for other wheelchair-dependent persons as well. Clinical Trial: German Clinical Trials Register DRKS00030370; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00030370
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