Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation— Addressing Clinical Needs (the PREHAB HTx Study)

Background To compare the effects of a 12-week PREHAB program and usual care (UC) on functional capacity in adults listed for heart transplantation (HTx). Secondary aims including comparing peak oxygen uptake (VO 2 peak), frailty, physical activity, mental health, cognitive function, quality of life (QoL), and dietary habits. Methods A multi-center RCT. Participants were randomized to prehabilitation (PREHAB) or UC. The 12-week PREHAB program included twice weekly high-intensity interval training (HIIT) sessions on an upright cycle ergometer, a stress management course, and a nutrition workshop. The primary outcome was functional capacity (6-minute walk test [6MWT] distance) from baseline to 12 weeks' follow-up. Secondary outcomes included changes in VO 2 peak, frailty, physical activity, severity of anxiety, depression, and stress, cognitive function, QoL, and dietary habits. Results Trial recruitment began in October 2018 and closed, due to the COVID-19 pandemic, in October 2020. Of 128 patients screened, 17 were recruited (age: 44±9 years, 71% male) and 4 were randomized (PREHAB=2, UC=2). Both patients completed PREHAB, and 1 patient completed UC. Reasons for drop-out throughout the trial included: transplanted, medication and device contraindications, commitment and travel constraints, and lack of interest. PREHAB showed potential for improvements in 6MWT distance (Baseline [B]: 427, Follow-up [FU]: 465 m), VO 2 peak (B: 14.9±0.1, FU: 15.8±0.4 mL/kg/min) and QoL using the Minnesota Living with Heart Failure Questionnaire (B: 41±33, FU: 26±1 points). Conclusions Recruitment for and completion of PREHAB for patients listed for HTx proved challenging. Given wait-time limitations, future research should examine alternative PREHAB programming offered sooner following listing which addresses reported barriers to participation.