Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: People with Multiple Sclerosis (MS) face varying levels of disability and symptoms, thus requiring highly trained therapists and/or exercise trainers to design personalized exercise programs. However, for people living in geographically isolated communities, access to such trained professionals can be challenging due to a number of barriers associated with cost, access to transportation and travel distance. Generic mHealth exercise apps often fall short of what people with MS need to become physically active (i.e., exercise content that has been adapted to accommodate a wide range of functional limitations). Objective: This usability study describes the development process of the TEAMS (Tele-Exercise and Multiple Sclerosis) app, which is being used by people with MS in a large randomized controlled trial (RCT) to engage in home-based telerehabilitation. Methods: Twenty-one participants with disabilities (10 people with MS) were involved in the double iterative design, which included the simultaneous development of the app features and exercise content (exercise videos and articles). Framed within a user-centered design (UCD) approach, the development process included two stages: ground-level creation (focus group followed by early stage evaluations and developments), and proof of concept through two usability tests. Usability (effectiveness, usefulness, and satisfaction) was evaluated through a mixed methods approach. Results: Regarding app effectiveness, the second usability test resulted in an average of one problem per participant, a decrease of 53% compared to the initial usability test. Five themes were constructed from the qualitative data that related to usefulness and satisfaction: high perceived confidence for app usability, positive perceptions of exercise videos, viable exercise option at home, orientation and familiarity required for successful participation, and app issues. Participants acknowledged that the final app was ready to be delivered to the public after minor revisions. After including these revisions, the project team released the final app that is being used in the RCT. Conclusions: A multi-level user-centered development process resulted in an inclusive exercise program for people with MS operated through an easy-to-use app. The promotion of exercise through self-regulated mHealth programs requires a stakeholder-driven approach to app development. This ensures that app and content match the preferences and functional abilities of the end user (i.e., people with varying levels of MS).

Background: Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study. Objective: In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study. Methods: The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8” step, and a large-print 8” × 11” paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months. Results: The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021. Conclusions: This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study. Trial Registration: ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881 International Registered Report Identifier (IRRID): DERR1-10.2196/18415

People with physical disabilities (PWD) experience several unique challenges that prevent them from participating in onsite exercise programs. Although mobile apps can provide a ubiquitous channel for delivering convenient exercise services within the community, no exercise apps have been designed for people with disabilities who experience certain functional limitations. The aim of this study was to examine the usability of a mobile exercise app in PWD. A sequential explanatory mixed-method design was used to holistically test usability in 4 core areas: effectiveness (ie, ease of use), efficiency (ie, operation speed), perceived satisfaction, and usefulness. Participants completed 7 face-to-face usability tasks and 1 structured interview. Equipment included a computer tablet that came preinstalled with the exercise app. The app included exercise videos that focused on several components of fitness: aerobic capacity, muscular strength, functional strength or balance, and range of motion. The app contained 3 different versions of the exercise program: (1) a program for people with the ability to use the upper and lower limbs, (2) a seated program for people with the ability to use only upper limbs, and (3) a program designed for people with hemiparesis. The app also included educational resources in the form of infographics aimed at addressing key social cognitive theory constructs included social support, outcome expectancies, self-efficacy, and barriers or facilitators to exercising. Participant characteristics and quantitative usability data were descriptively reported. Qualitative data were analyzed using thematic analysis. A total of 12 PWD tested the usability of the exercise app and completed 96% (69/72) of the usability tasks on the first attempt. Operation speed varied among users, which prompted the development team to make minor revisions to the app. Qualitative results demonstrated 3 overarching themes: facilitates exercise adoption, positive experiences of videos, and easy to learn. Participants noted that the app circumvented several barriers to exercise associated with leaving the home (eg, inclement weather conditions, exacerbations of health conditions or disability symptoms, difficulties with transportation, and social support). The mobile exercise app provided a simple platform that was effective, useful, and appreciated by PWD. Participants also perceived the app as easy to use and felt it was a valuable tool for assisting PWD to obtain regular exercise. Study findings also offered insight into the participants' preferences for mobile exercise apps that can aid future research and development projects. Future exercise trials are needed to determine the true impact of mobile app technology on lifestyle physical activity in people with disabilities. Clinicaltrials.gov NCT03024320; https://clinicaltrials.gov/ct2/show/NCT03024320 (Archived by WebCite at http://www.webcitation.org/75hNLgRFH).