Rationale and design of a Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) in people with physical/mobility disabilities: a type 1 hybrid design effectiveness trial

• Published in: BMJ open 2019-03, Vol.9 (3), p.e023538-e023538
• Main Authors: Rimmer, James H, Mehta, Tapan, Wilroy, Jereme, Lai, Byron, Young, Hui-Ju, Kim, Yumi, Pekmezi, Dorothy, Thirumalai, Mohanraj
• Format: Article
• Language: English
• Subjects: Clinical trials; Diabetes; Disability; Disabled Persons - rehabilitation; Exercise; Exercise Therapy - methods; Handicapped accessibility; Home Care Services; Humans; Internet; Intervention; Lifestyles; Medical research; Nutrition; Participation; People with disabilities; Physical fitness; Quality of Life; Randomized Controlled Trials as Topic; Rehabilitation Centers; Rehabilitation Medicine; Self Report; Telemedicine; Usability
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2018-023538

IntroductionRates of physical inactivity among people with physical disabilities are substantially higher than in the general population and access to home-based tailored exercise programmes is almost non-existent. Using a theory-driven eHealth platform, an innovative exercise programme referred to as movement-to-music (M2M) will be delivered as a customised, home-based exercise intervention for adults with mobility disabilities.Methods and analysisParticipants are being recruited for this type 1 hybrid design based effectiveness trial through outpatient clinics at a large rehabilitation centre and randomised to one of three groups: (1) M2M, (2) M2M plus social networking (M2Mplus) and (3) attention control (AC). The intervention includes a 12-week adoption phase, 12-week transition phase and 24-week maintenance phase, at which the collection of objective measures on exercise, fitness and self-reported measures on health will be obtained at the start of each phase and at follow-up. The study compares the effectiveness of M2M and M2Mplus in increasing physical activity (primary outcome), adherence, fitness and physical functioning compared with the AC group and examines the mediators and moderators of the treatment effect.Ethics and disseminationThe Institutional Review Board of The University of Alabama at Birmingham granted full approval: (IRB-160923002). Dissemination of findings will include publication in peer-reviewed journals, presentations at regional, national and/or international meetings, and the National Center on Health, Physical Activity and Disability (NCHPAD, www.nchpad.org). This study will strengthen our understanding of the potential benefits of eHealth exercise interventions for people with physical disabilities and build on strategies that aim to recruit larger samples in exercise trials.Trial registration number NCT03024320; Pre-results.