Mind and body rehab program aims to boost quality of life in heart disease survivors
NCT ID NCT05670132
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This trial tests a 12-week neurocardiac rehabilitation program for children, adolescents, and young adults with moderate to complex congenital heart disease. The program combines home-based physical exercise, telehealth psychoeducation for parents and children, and computerized cognitive training. Researchers will compare quality of life, cognitive skills, and mental health outcomes between those who receive the program and those who receive standard care over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Neurocardiac rehabilitation program (home-based adaptive exercise, telehealth psychoeducation, computerized cognitive training)
- What this could lead to
- If it works, this program could become a standard holistic rehab approach to improve quality of life, mental health, and cognitive skills in young people with congenital heart disease.
- What could go wrong
- This is a relatively small trial (192 participants) testing a complex intervention, so results may not generalize widely. The program requires significant commitment from families, and benefits may vary.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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8 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Deutsches Herzzentrum München
NOT_YET_RECRUITINGMünchen, D-80636, Germany
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Hôpital Necker-Enfants malades (AP-HP)
RECRUITINGParis, France, 75015, France
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Saint-Luc University Hospital
RECRUITINGBrussels, Belgium
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Saint-Pierre Institute
RECRUITINGPalavas-les-Flots, 34250, France
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University Hospital of Bordeaux - Haut-Levêque Hospital
RECRUITINGPessac, 33604, France
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University Hospital of Montpellier - Arnaud de Villeneuve Hospital
RECRUITINGMontpellier, 34295, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A new roadmap to transplant: could standardizing care save more congenital heart patients?
- Virtual counseling may help mothers facing a fetal heart defect
- A tiny plug in the lung arteries may offer a gentler path for children with heart defects
- Can a blood filter tame the inflammatory storm after pediatric heart surgery?
- Heart surgery in childhood: a hidden impact on speech and memory?