Feasibility, Usability, and Safety of ParaGym, an Intelligent Mobile Exercise App for Individuals With Paraplegia: Protocol for a Pilot Block-Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Exercise is crucial for individuals with paraplegia to reduce the risk of secondary diseases and improve independence and quality of life. However, numerous barriers such as inadequate accessibility restrict their participation in exercise programs. Digital exercise apps can help overcome these barriers. Personalization is considered a crucial feature of mobile exercise apps, as people with paraplegia have individual requirements regarding exercise programs depending on their level of impairment. Despite the increasing popularity of mobile exercise apps, there are none available that target the individual needs of this cohort. The ParaGym mobile exercise app prototype was designed to automatically tailor exercise sessions to the individual needs of users with paraplegia. OBJECTIVE This study aims to evaluate the feasibility, usability, safety, and preliminary effectiveness of the ParaGym mobile exercise app prototype. METHODS This pilot block-randomized controlled feasibility trial will include 45 adult participants with paraplegia. Eligible participants will be block randomized to either the intervention or waitlist control group. 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. Participants will record all exercise sessions conducted with the app as well as additional exercise sessions conducted during the study period using exercise diaries. The primary outcomes include feasibility, usability, and safety. Feasibility will be assessed through semistructured interviews, study adherence, and retention rates. Usability will be measured using the System Usability Scale. Safety will be determined by the occurrence of adverse events. Secondary outcomes include the effects of the intervention on peak exercise capacity (VO<sub>2</sub> peak); handgrip strength; independence, which will be measured using the Spinal Cord Independence Measure III (SCIM III); and health-related quality of life, which will be measured using the Short Form–36 Health Survey (SF-36). RESULTS Recruitment commenced in November 2022. Overall, 12 participants were enrolled at the time of submission. Data collection commenced in January 2023, with completion expected 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. Thereafter, the app should be adapted according to the findings of this trial. Future trials with an updated version of the app should aim for a larger sample size, longer intervention duration, and more diverse target group. In the long term, a fully marketable version of the ParaGym app should be implemented. This would increase the access to personalized, independent, and evidence-based exercise training for this cohort and, in the future, other people who use wheelchairs. CLINICALTRIAL German Clinical Trials Register DRKS00030370; https://drks.de/search/de/trial/DRKS00030370 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/45652