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

Cristine Schmidt; Sandra Magalhães; Priscilla Gois Basilio; Marisol Gouveia; Manuel Teixeira; Cláudio Santos; Aida Isabel Tavares; João Pedro Ferreira; Fernando Ribeiro; Mário Santos

doi:10.1016/j.repc.2023.05.013

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

Rev Port Cardiol. 2024 Mar;43(3):149-158. doi: 10.1016/j.repc.2023.05.013. Epub 2023 Sep 15.

[Article in English, Portuguese]

Affiliations

¹ Surgery and Physiology Department, Faculty of Medicine, University of Porto, Portugal; Research Center in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, Portugal; Laboratory for Integrative and Translational Research in Population Health (ITR), Porto, Portugal.
² Department of Physical and Rehabilitation Medicine, Centro Hospitalar Universitário de Santo António (CHUdSA), Porto, Portugal.
³ Research Center in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, Portugal.
⁴ iBiMED - Institute of Biomedicine, Department of Medical Sciences, University of Aveiro, Portugal.
⁵ CEISUC - Centre for Health Studies and Research, University of Coimbra, Coimbra, Portugal; ISEG, UL - Lisbon School of Economics and Management, University of Lisbon, Portugal.
⁶ Cardiovascular R&D Centre - UnIC@RISE, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Portugal; Université de Lorraine, Inserm, Centre d'Investigations Cliniques, Plurithématique 14-33, and Inserm U1116, CHRU Nancy, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
⁷ iBiMED - Institute of Biomedicine, School of Health Sciences, University of Aveiro, Aveiro, Portugal.
⁸ Cardiology Service, Centro Hospitalar Universitário de Santo António (CHUdSA), Porto, Portugal; UMIB, Instituto de Ciências Biomédicas Abel Salazar, University of Porto, Portugal; Laboratory for Integrative and Translational Research in Population Health (ITR), Porto, Portugal. Electronic address: mariossantos001@gmail.com.

PMID: 37716466
DOI: 10.1016/j.repc.2023.05.013

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 combination of endurance [(at 60%-80% of peak oxygen uptake (VO₂peak)] and resistance training (elastic bands). Those allocated to the home-based program will start with 4-5 supervised ExT sessions to familiarize themselves with the training protocol and then will continue the remaining sessions at home. The primary endpoint is the change in VO₂peak at the end of the 12-week program. Secondary outcomes include alterations in circulating biomarkers, physical fitness, physical activity, quality of life, diet, psychological wellbeing, dyspnea, and cost-effectiveness analyses.

Results: Patients are currently being recruited for the study. The study started in November 2019 and data collection is anticipated to be completed by December 2022. This is the first study in 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 regarding CR.

Keywords: Cardiac rehabilitation; Heart failure; Home-based; Insuficiência cardíaca; Programa domiciliário; Reabilitação cardíaca.

Publication types

Randomized Controlled Trial
Pragmatic Clinical Trial

MeSH terms

Adult
Cardiac Rehabilitation*
Exercise Therapy
Heart Failure* / therapy
Humans
Quality of Life
Single-Blind Method