Home-based neuro-cardiac rehabilitation in congenital heart disease: the QUALINEURO-REHAB trial study protocol

INTRODUCTION: Neurodevelopmental impairments and physical deconditioning are the most common long-term morbidities in congenital heart disease (CHD). Holistic interventions including combined neuro-cardiac training may improve physical and mental health in youth with CHD. METHODS AND ANALYSIS: This is a European multicentre, two-arm randomised controlled study to test the efficacy of a home-based neuro-cardiac rehabilitation programme including physical activity and neuropsychological training versus the standard of care in children, adolescents and young adults with complex CHD. Patients aged 8-25 years who underwent infant surgical and/or catheter-based cardiac interventions will be randomly allocated to either an intervention group including a 12-week home-based cardiovascular rehabilitation and executive function training or to a control group. All participants will undergo a baseline assessment and a 12-month follow-up. The primary outcome is the difference in change in the Pediatric Quality of Life Inventory self-reported health-related quality of life score between baseline and final assessment for the intervention versus the control group. Secondary outcomes include standardised neuropsychological measures of executive function, social cognition and mental health. Cardiovascular secondary outcomes include cardiopulmonary fitness parameters such as maximum oxygen uptake, muscular strength and level of physical activity. Efficacy of the intervention will be evaluated by comparing within-subject group differences from baseline to 12-month follow-up, using an intention-to-treat analysis. ETHICS AND DISSEMINATION: The trial protocol was first approved by the sponsor's drawn National Ethics Committee (CPP Paris-III, number 2023-A00038-37) and registered on Clinicaltrial.gov (number NCT05670132). It was also approved by Ethics Committees in Germany (Technische Universitat Munchen, number 2023-276-S-KH) and Belgium (UCLouvain, number B4032025000116). TRIAL REGISTRATION NUMBER: NCT05670132.