Neuro-cardiac rehabilitation for children and young adults with complex congenital heart disease
Official title: 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
Run by University Hospital, Bordeaux · NCT05670132 · Data updated 2026-11-12
This program will test whether a 12-week home-based neuro-cardiac rehabilitation program can improve quality of life, mental health, and exercise capacity in 8–25-year-olds with complex congenital heart disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 25 Years |
| Sex | All |
| Enrollment | 192 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Brussels and 5 other locations) |
| Status | Recruiting |
| Started | June 3, 2024 |
| Main results expected | June 3, 2028 |
| Study ends | June 3, 2028 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT05670132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are medically stable children, adolescents, and young adults aged 8–25 with moderate-to-great complexity congenital heart disease who had cardiac surgery or catheter intervention in their first year of life.
✕Probably not a fit
Patients with unstable or severe heart failure, significant hypoxaemia, pulmonary hypertension, low systolic ventricular function (EF <50%), or those requiring oxygen therapy are excluded and unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicentre, randomized two-arm trial compares a 12-week integrated neuro-cardiac rehabilitation program to standard cardiology follow-up in young people with rare or complex congenital heart disease. The intervention combines home-based adaptive physical exercise, telehealth parent and child psychoeducation, computerized cognitive training, and periodic in-person reinforcement sessions. Outcomes include patient-reported health-related quality of life (primary outcome), neurodevelopmental and mental health measures, and cardiopulmonary exercise testing, with primary analyses at 12 months post-enrolment. Participants are aged 8–25 and have moderate-to-great complexity CHD and prior early-life cardiac intervention(s).
Why it matters
Potential benefit: If effective, the program could meaningfully improve long-term quality of life, mental health, and physical fitness for young people with complex CHD.
How similar studies have gone: Individual components such as exercise training and cognitive rehabilitation have shown benefits in related populations, but a combined neuro-cardiac program for rare CHD is novel and not yet widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient with a CHD of moderate to great complexity as defined in the 2019 AHA/ACC guidelines (Appendix 2)85. 2. History of cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life. 3. Age between 8 and 25 years at the time of enrolment. 4. Parental or legal guardian's consent for minors (\<18 years) and personal consent for adults. 5. Social security affiliation (for France only) Exclusion Criteria: 1. Unstable and/or severe heart failure: severe heart failure (class IV NYHA functional class), recent decompensated heart failure requiring hospitalisation and/or any significant change in medication (\< 3 months before enrolment), systolic ventricle dysfunction (left ventricle or systemic ventricle ejection fraction \< 50%)82. 2. Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest \<85%, and/or SpO2 at exercise \<80%, and/or patient requiring oxygen therapy. 3. Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology83. 4. Significant systolic right ventricle (sRV) hypertension (sRV pressure \> 50% of systemic systolic pressure). 5. Uncontrolled arrhythmia: symptomatic treated or untreated arrhythmia at rest and/or exercise, treated arrhythmia with sustained supraventricular or ventricular tachycardia on ECG monitoring or during exercise and/or CPET, occurrence or aggravation of any supraventricular or ventricular arrhythmia during exercise and/or CPET. 6. Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and/or CPET. 7. Uncontrolled arterial hypertension at rest (e.g. if the blood pressure at rest during the consultation \>140/90 mmHg in adults, \>95th percentile in children84). 8. Acute or recent (\< 3 months) myocarditis and pericarditis. 9. Symptomatic aortic or sub-aortic stenosis (mean gradient \> 50 mmHg). 10. Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient \> 20 mmHg. 11. Dilatation of the aorta (aortic root \> 40 mm in adults, \> 2 Z-score in children85 (http://www.parameterz.com/sites/aortic-root) except in the case of repaired congenital heart disease with dilatation of the aorta inherent in the malformation and without significant risk of aortic dissection (tetralogy of Fallot, pulmonary atresia with VSD, transposition of the great arteries, truncus arteriosus, double outlet right ventricle, or single ventricle). 12. Severe hypertrophic obstructive cardiomyopathy. 13. Acute systemic illness. 14. Recent (\<3 months) intracardiac thrombus, embolism, or thrombophlebitis. 15. Inability to follow instructions and/or complete the questionnaires, as determined by the investigator. 16. Absolute contraindications for CPET: fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or haemodynamic compromise, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction, and patients with mental impairment leading to inability to cooperate. 17. Inability to undergo the physical intervention: inability to physically exercise, any invasive medical intervention occurring within 6 months preceding the enrolment or scheduled during the 12-month study period (such as cardiac surgery, catheter-based intervention, orthopaedic surgery, chemotherapy for cancer, or any other significant medical treatment or intervention, as determined by the investigator). 18. Patient with a previously diagnosed or suspected severe psychiatric disorder (major depression with or without suicidal ideation, psychotic diagnoses, severe anxiety /panic disorders) requiring hospitalization and/or continuous specialized care by a psychiatrist, as determined by the investigator. 19. Patients who benefited from a cardiac rehabilitation within the 12 months preceding the enrolment. 20. Patients who benefited from a computerized executive function or attention training such as Cogmed Working Memory Program within the 12 months preceding the enrolment. 21. For female patients: pregnancy, pregnancy plan, or breastfeeding woman following questioning of the patient. 22. Patients deprived of liberty due to an ongoing legal procedure, adult's patient under guardianship or curatorship or unable to personally express their consent. 23. Any other clinical and/or pharmacological treatment that is believed to interfere with the study or the optimal clinical care. 24. Initiation or total withdrawal of psychotropic medication (i.e., any psychotropic medication including methylphenidate, benzodiazepines, and mood stabilizers) within the 6 months preceding the enrolment. 25. Patient participating or wishing to participate in any interventional clinical research (drug trial, medical device, non-drug trial).
Where it's running
-
Saint-Luc University Hospital
Brussels, Belgium Recruiting -
Hôpital Necker-Enfants malades (AP-HP)
Paris, France, France Recruiting -
University Hospital of Montpellier - Arnaud de Villeneuve Hospital
Montpellier, France Recruiting -
Saint-Pierre Institute
Palavas-les-Flots, France Recruiting -
University Hospital of Bordeaux - Haut-Levêque Hospital
Pessac, France Recruiting -
Deutsches Herzzentrum München
München, Germany Not yet recruiting
Study contacts
- Principal investigator: Pascal AMEDRO, MD,PhD — University Hospital, Bordeaux
- Study coordinator: Pascal AMEDRO, MD,PhD
- Email: pascal.amedro@chu-bordeaux.fr
- Phone: 05 57 65 61 09
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.