{ "abstract": "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 .", "abstract_shown": true, "affiliations": [ "Cardiac Neurodevelopmental Center - CNC Necker, National Reference Center for Complex Congenital Heart Diseases M3C, APHP, Université Paris Cité, Hôpital Necker-Enfants Malades, Paris, France", "French National Institute of Health and Medical Research, PhyMedExp, Cardiac Neurodevelopmental Research Group, Inserm U1046, Montpellier, France", "Unit of Pediatric and Congenital Cardiology, Montpellier University Hospital, Montpellier, France", "Department of Pediatric and Congenital Cardiology, National Reference Centre for Complex Congenital Heart Disease, Bordeaux, France", "Department of Congenital Heart Defects and Pediatric Cardiology, TUM University Hospital, Deutsches Herzzentrum München, Munich, Germany", "INSERM U1045, University of Bordeaux, IHU Liryc Institut des Maladies du Rythme Cardiaque, Pessac, France", "Epidemiology and Clinical Research Department, Montpellier University Hospital, Montpellier, France", "Public Health Department, Bordeaux University Hospital, Bordeaux, France", "Public Health Department, Medical Information Unit, CHU Bordeaux, Bordeaux, France", "Bordeaux Population Health, INSERM U1219, Bordeaux, France", "USMR, CHU de Bordeaux, Bordeaux, France", "Pediatric cardiology, University Hospital Centre Bordeaux, Pessac, France", "Le Hillot Cardiac Rehabilitation Center, Bordeaux, France", "Division of Pediatric Cardiology, Department of Pediatrics, Cliniques universitaires Saint-Luc, Brussels, Belgium", "UCLouvain, Louvain-la-Neuve, Belgium", "Montpellier University Hospital, Montpellier, France", "Pediatric Cardiology, University Hospital of Montpellier, Montpellier, France", "U1046 PhyMedExp, National Institute of Health and Medical Research, Montpellier, France", "Patient Association Petit Coeur de Beurre, La Garenne Colombes, France", "Patient Association Petit Coeur de Beurre, Paris, France", "Department of Congenital Heart Defects and Pediatric Cardiology, Deutsches Herzzentrum München, Munich, Germany", "TUM University Hospital, Munich, Germany", "Clinical Research and Innovation Department, Bordeaux University Hospital, Bordeaux, France", "M3C Cardiologie Pediatrique, Hôpital Universitaire Necker-Enfants Malades, Paris, France", "University Hospital of Montpellier, Montpellier, France", "Department of Pediatric and Congenital Cardiology, George Washington University School of Medicine & Health Sciences, Heart & Lung Center — Children’s National Hospital, Washington, DC, USA", "University of Bordeaux, Talence, France" ], "article_type": null, "arxiv": null, "author_total": 24, "authors": [ { "affs": [ 0, 1, 2 ], "name": "Johanna Calderon", "orcid": "0000-0002-2644-6858" }, { "affs": [ 0, 1, 3 ], "name": "Sylvie Martins" }, { "affs": [ 4 ], "name": "Alfred Hager" }, { "affs": [ 3, 5 ], "name": "Lauriane Cornuault" }, { "affs": [ 3 ], "name": "Cecile Jore" }, { "affs": [ 3, 5 ], "name": "Mathieu Andrianoely" }, { "affs": [ 6 ], "name": "Marie-Christine Picot" }, { "affs": [ 7 ], "name": "Florence Francis" }, { "affs": [ 8, 9 ], "name": "Florence Saillour" }, { "affs": [ 10 ], "name": "Marion Kret", "orcid": "0009-0003-9982-3903" }, { "affs": [ 11 ], "name": "Anne Cécile Huby", "orcid": "0009-0000-8845-3861" }, { "affs": [ 3, 12 ], "name": "Marion Audie" }, { "affs": [ 3 ], "name": "Pierre-Marie Duboue" }, { "affs": [ 13, 14 ], "name": "Jelena Hubrechts", "orcid": "0000-0001-6719-2746" }, { "affs": [ 15 ], "name": "Gregoire De La Villeon" }, { "affs": [ 16, 17 ], "name": "Marie Vincenti" }, { "affs": [ 18 ], "name": "Gaelle Marguin" }, { "affs": [ 18, 19 ], "name": "Gwladys Desmure" }, { "affs": [ 20, 21 ], "name": "Julia Hock" }, { "affs": [ 22 ], "name": "David Schmitz" }, { "affs": [ 23 ], "name": "Damien Bonnet" }, { "affs": [ 13, 14 ], "name": "Stephane Moniotte" }, { "affs": [ 24 ], "name": "Sophie Guillaumont" }, { "affs": [ 25, 26 ], "name": "Pascal Amedro" } ], "bibtex": "https://research.draconitic.com/paper/7hdn3mk4mz0h5.bib", "cited_by": 0, "doi": "10.1136/bmjopen-2026-120953", "fulltext_url": null, "id": "7hdn3mk4mz0h5", "issns": [ "2044-6055" ], "landing_url": "https://hal.science/hal-05780114v1", "language": "en", "licence": "CC-BY-4.0", "licence_label": "CC BY 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "hal", "0.sdv" ], [ "openalex", "2713|Congenital Heart Disease Studies" ] ], "openalex": "W7220366518", "pdf_url": "https://hal.science/hal-05780114/document", "pmcid": null, "pmid": null, "published": "2026-10-05", "publisher": "BMJ Publishing Group", "ris": "https://research.draconitic.com/paper/7hdn3mk4mz0h5.ris", "sources": [ { "first_seen": "2026-10-30T12:18:01Z", "native_id": "hal-05780114", "source": "hal", "url": "https://hal.science/hal-05780114v1" }, { "first_seen": "2026-10-30T12:19:44Z", "native_id": "10.1136/bmjopen-2026-120953", "source": "crossref", "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-120953" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2713|Congenital Heart Disease Studies", "subfield": "epidemiology-public-health" } ], "title": "Home-based neuro-cardiac rehabilitation in congenital heart disease: the QUALINEURO-REHAB trial study protocol", "title_text": "Home-based neuro-cardiac rehabilitation in congenital heart disease: the QUALINEURO-REHAB trial study protocol", "type": "peer-reviewed", "updated_at": "2026-10-30T12:19:44Z", "url": "https://research.draconitic.com/paper/7hdn3mk4mz0h5", "venue": "BMJ Open", "versions": [] }