Abstract
BACKGROUND: To compare the effects of a 12-week prehabilitation (PREHAB) program vs usual care (UC) on functional capacity in adults listed for heart transplantation. Secondary aims included comparing peak oxygen uptake ( V˙ O(2)peak), frailty, physical activity, mental health, cognitive function, quality of life (QoL), and dietary habits. METHODS: A multicentre randomized controlled trial was conducted. Participants were randomized to PREHAB or UC. The 12-week PREHAB program included twice weekly high-intensity interval training sessions on an upright cycle ergometer, a stress management course, and a nutrition workshop. The primary outcome was functional capacity (6-minute walk test distance) from baseline to 12 weeks of follow-up. Secondary outcomes included changes in V˙ O(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 84 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 dropout throughout the trial included the following: receiving a transplant; medication and device contraindications; commitment and travel constraints; and lack of interest. PREHAB showed potential for improvements in the 6-minute walk test distance (Baseline [B]: 343 ± 120; follow-up [FU]: 465 m), V˙ O(2)peak (B: 14.9 ± 0.1; FU: 15.8 ± 0.4 mL/kg/min), and QoL measured 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 heart transplantation proved challenging. Given wait-time limitations, future research should examine alternative PREHAB programming, offered sooner following listing, that addresses reported barriers to participation. CLINICAL TRIAL REGISTRATION: NCT02957955.