Home- versus centre-based EXercise InTervention in patients with Heart Failure (EXIT-HF trial): A pragmatic randomized controlled trial

Abstract

Introduction: The limited accessibility and the lack of adherence explain, in part, the low proportion of heart failure (HF) patients undergoing exercise-based cardiac rehabilitation (CR) programs. Home-based programs showed to be as effective and less costly than centre-based ones and might address those obstacles. Whether the evidence from international studies can be applied to our population is still unclear. Objectives: To compare the clinical and economic impact of a home-based versus centre-based CR intervention in HF patients. Methods: This is a single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial. Adult HF patients (n=120) will be randomized to either a centre-based or home-based CR program. In both groups’ patients will participate in a 12-week combined CR program with 2 sessions per week. Exercise training (ExT) protocol consists of a combinationof endurance [(at 60%---80% of peak oxygen uptake (VO2peak)] and resistance training (elasticbands). Those allocated to the home-based program will start with 4---5 supervised ExT ses-sions to familiarize themselves with the training protocol and then will continue the remainingsessions at home. The primary endpoint is the change in VO2peak at the end of the 12-weekprogram. Secondary outcomes include alterations in circulating biomarkers, physical fitness,physical activity, quality of life, diet, psychological wellbeing, dyspnea, and cost-effectivenessanalyses.Results: Patients are currently being recruited for the study. The study started in November2019 and data collection is anticipated to be completed by December 2022. This is the first studyin Portugal comparing the traditional CR program with a home-based program in HF patients.Our study results will better inform healthcare professionals who care for HF patients regardingCR.