Evidence map›Paper›PMID 42833711›Full record

ArticleBMJ open2026

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

Johanna Calderon, Sylvie Martins, Alfred Hager, Lauriane Cornuault, Cecile Jore, Mathieu Andrianoely, Marie-Christine Picot, Florence Francis, Florence Saillour, Marion Kret and 15 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05670132 (Impact of a Neuro-cardiac Rehabilitation Program on the Quality of Life of Children, Adolescents, and Young Adults With Congenital Heart Disease), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05670132 narecruitingnot on this map

Impact of a Neuro-cardiac Rehabilitation Program on the Quality of Life of Children, Adolescents, and Young Adults With Congenital Heart Disease: the Multicentre Randomized Controlled QUALINEUROREHAB Trial

TypeinterventionalSponsorUniversity Hospital, BordeauxRan2024 to 2028Enrolled192ConditionsCongenital Heart DiseaseArmsNeurocardiac rehabilitation program, Standard of care
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Johanna CalderonCardiac Neurodevelopmental Center - CNC Necker, National Reference Center for Complex Congenital Heart Diseases M3C, APHP, Université Paris Cité, Hôpital Necker-Enfants Malades, Paris, France johanna.calderon@inserm.fr.ORCID http://orcid.org/0000-0002-2644-6858
Sylvie MartinsCardiac Neurodevelopmental Center - CNC Necker, National Reference Center for Complex Congenital Heart Diseases M3C, APHP, Université Paris Cité, Hôpital Necker-Enfants Malades, Paris, France.
Alfred HagerDepartment of Congenital Heart Defects and Pediatric Cardiology, TUM University Hospital, Deutsches Herzzentrum München, Munich, Germany.
Lauriane CornuaultDepartment of Pediatric and Congenital Cardiology, National Reference Centre for Complex Congenital Heart Disease, Bordeaux, France.
Cecile JoreDepartment of Pediatric and Congenital Cardiology, National Reference Centre for Complex Congenital Heart Disease, Bordeaux, France.
Mathieu AndrianoelyDepartment of Pediatric and Congenital Cardiology, National Reference Centre for Complex Congenital Heart Disease, Bordeaux, France.
Marie-Christine PicotEpidemiology and Clinical Research Department, Montpellier University Hospital, Montpellier, France.
Florence FrancisPublic Health Department, Bordeaux University Hospital, Bordeaux, France.
Florence SaillourPublic Health Department, Medical Information Unit, CHU Bordeaux, Bordeaux, France.
Marion KretUSMR, CHU de Bordeaux, Bordeaux, France.ORCID http://orcid.org/0009-0003-9982-3903
Anne Cécile HubyPediatric cardiology, University Hospital Centre Bordeaux, Pessac, France.ORCID http://orcid.org/0009-0000-8845-3861
Marion AudieDepartment of Pediatric and Congenital Cardiology, National Reference Centre for Complex Congenital Heart Disease, Bordeaux, France.
Pierre-Marie DuboueDepartment of Pediatric and Congenital Cardiology, National Reference Centre for Complex Congenital Heart Disease, Bordeaux, France.
Jelena HubrechtsDivision of Pediatric Cardiology, Department of Pediatrics, Cliniques universitaires Saint-Luc, Brussels, Belgium.ORCID http://orcid.org/0000-0001-6719-2746
Gregoire De La VilleonMontpellier University Hospital, Montpellier, France.
Marie VincentiPediatric Cardiology, University Hospital of Montpellier, Montpellier, France.
Gaelle MarguinPatient Association Petit Coeur de Beurre, La Garenne Colombes, France.
Gwladys DesmurePatient Association Petit Coeur de Beurre, La Garenne Colombes, France.
Julia HockDepartment of Congenital Heart Defects and Pediatric Cardiology, Deutsches Herzzentrum München, Munich, Germany.
David SchmitzClinical Research and Innovation Department, Bordeaux University Hospital, Bordeaux, France.
Damien BonnetM3C Cardiologie Pediatrique, Hôpital Universitaire Necker-Enfants Malades, Paris, France.
Stephane MoniotteDivision of Pediatric Cardiology, Department of Pediatrics, Cliniques universitaires Saint-Luc, Brussels, Belgium.
Sophie GuillaumontUniversity Hospital of Montpellier, Montpellier, France.
Pascal AmedroDepartment of Pediatric and Congenital Cardiology, George Washington University School of Medicine & Health Sciences, Heart & Lung Center - Children's National Hospital, Washington, DC, USA.
QUALINEURO-REHAB study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNeurodevelopmental 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.

Indexed as

Exercise TherapyHeart Defects, CongenitalHome Care ServicesAdolescentAdultChildExecutive FunctionExerciseFemaleHumansMaleMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicResearch DesignYoung AdultCongenital heart diseaseDevelopmental neurology & neurodisabilityPatient Reported Outcome MeasuresPhysical FitnessPsychosocial Intervention

Identifiers

PMID42833711
PMCPMC13646947

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.