Rehabbing with Peloton: Commercially Available Fitness mHealth for Cardiac Rehabilitation among Individuals Recovering from Transcatheter Aortic Valve Replacement - ABSTRACT The proposed project is a resubmission by two promising Early-Stage Investigators as multiple principal investigators (PAR-22-189). The overall goal of this multi-phase proposal is to prepare for (R61) and execute (R33) a randomized clinical trial testing the effectiveness of Rehabbing with Peloton for improving physical activity among patients receiving transcatheter aortic valve replacement (TAVR) and evaluating the implementation of the intervention for future scalability. Despite ample evidence of the benefits of cardiac rehabilitation, only a small fraction of TAVR patients participate, which is thought to be a combination of missed referral opportunities coupled with patient-borne challenges including transportation, scheduling, and physical access to facilities. Participation in cardiac rehabilitation is particularly low among women and racial and ethnic minorities, as well as those with lower socioeconomic status, and/or living in rural areas, contributing to disproportionate morbidity and mortality burden in these patients. Overseeing cardiac rehabilitation content on commercially available fitness platforms (such as the Peloton mobile app) may be an excellent format for ensuring rehabilitation-appropriate modules while reaching TAVR patients currently under-referred and underusing cardiac rehabilitation. In our preliminary work, we engaged TAVR patients and cardiologists to develop the Rehabbing with Peloton intervention. RWP is an 8-week intervention in which TAVR patients engage with the Peloton app (not the fitness bike) to promote physical activity. RWP is a clinically reviewed, pre-set user account controlled by the research team that includes specific modules focusing on walking, strength exercises, yoga breathwork, and stretching, areas of exercise training previously used in home-based cardiac rehabilitation. Building on our previous multidisciplinary research, this proposal describes an innovative type II effectiveness-implementation hybrid randomized control trial of TAVR patients comparing RWP to attention control, controlling for technology. We will dedicate the R61 phase of the project to milestone-driven startup of the trial to successfully start recruitment by month 9 of the project. During the R33 phase, we will randomize N=200 individuals receiving TAVR from the University of Colorado Hospital Heart and Vascular Center to RWP or attention control. At baseline, post-intervention (8 weeks), and follow-up (12 months), we will assess participants’ physical activity (smartwatch accelerometer measured daily steps) and secondary outcomes of interest including functional capacity (Duke Activity Status Index; VO2max), quality of life (Kansas City Cardiomyopathy Questionnaire), and cardiovascular health status (Life Essential 8). The aims of the study are to test the efficacy of RWP on physical activity at 8 weeks (Aim 1) and secondary outcomes (Aim 2). We will use mixed methodologies to evaluate the implementation of RWP using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework (Aim 3). Overall, this research will provide insight into the use of commercial mHealth to deliver CR to a population disproportionately excluded from CR.
