Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)

NCT05670132 | Recruiting

• 1 other identifier: CHUBX 2021/66
• Study Type: interventional
• Target: 290
• Locations: 3 countries
• Sites: 5

Brief Summary

Remarkable progress in paediatric cardiology and surgery have led to the substantial increase of congenital heart disease (CHD) survivors. Long-term outcomes in rare and complex CHD have become a critical priority as three major sources of morbidity have been identified in this population: neurodevelopmental sequelae, mental health issues and reduced exercise capacity. These challenges adversely affect their quality of life and constitute a major public health issue. We seek to evaluate the efficacy of the first integrative and holistic program in Neuro-Cardiac Health associating physical and psychological rehabilitation for children with rare CHD compared to the standard of care. Children randomly assigned to the intervention will undergo a 12-week neuro-cardiac intervention including home-based adaptive physical exercise, telehealth parent and child psycho-education and child computerized cognitive training, as well in-person individual sessions of intervention reinforcement. Parents will be actively involved and will receive personalized feedback and educational resources. Children assigned to the control group will receive the standard of care in congenital cardiology. Post-intervention effects will be measured after 12-months on several outcomes including health-related quality of life (HRQoL), trained and untrained cognitive skills, mental health outcomes and cardiovascular/physical variables.

Conditions

Congenital Heart Disease

Keywords

Neuro-cardiac rehabilitation program; Quality of life

Outcome Measures

Primary Outcomes (1)

• Total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire

  Change in the self-reported total score of the PedsQL 4.0 questionnaire between baseline (Month 0) and the end of follow-up (Month 12) in both groups.

  between Month 0 and Month 12

Secondary Outcomes (19)

• Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL) for paediatric patients

  between Month 0 and Month 12

• Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)

  between Month 0 and Month 12

• Behaviour Rating Inventory of Executive Function (BRIEF) scale scores

  between Month 0 and Month 12

• Wisconsin Card Sorting Test scale score

  between Month 0 and Month 12

• Wechsler Intelligence Scale scores

  between Month 0 and Month 12

Study Arms (2)

Neurocardiac rehabilitation program

EXPERIMENTAL

The home-based neuro-cardiac rehabilitation program will consist of weekly sessions of neuro-cardiac training during 12 weeks at home. * The physical activity training consists of two 1-hour sessions of adapted physical activities per week supervised by an APA educator or equal. One weekly session is held in person, at home, and the second one in videoconference. All training sessions follow the same scheme with 30 minutes of bicycle training, adapted from high-intensity training (30-33), and 30 minutes of "free" adapted physical activities * The neuropsychological component will consist of 2 home-based weekly 25-minute sessions of computerized cognitive training via the new platform of CogMed (standard format) for the patient and 1 weekly 30/45-min teleconsultation session of neuropsychological feedback on every-day life emotional regulation and executive functioning applied to school and family life for either the parent (for ages 17 and younger) or young adults with CHD.

Other: Neurocardiac rehabilitation program

Standard of care

ACTIVE COMPARATOR

The control group will follow European recommendations for cardiology care (standard of care) without introducing any additional interventions for research purposes at the exception of primary (HRQoL questionnaires) and secondary outcomes

Other: Standard of care

Interventions

Neurocardiac rehabilitation program OTHER

Patients receiving a neurocardiac rehabilitation program for 12 weeks.

Neurocardiac rehabilitation program

Standard of care OTHER

No intervention during the neurocardiac rehabilitation program

Standard of care

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient with a CHD of moderate to great complexity as defined in the 2019 AHA/ACC guidelines (Appendix 2)85.
• History of cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life.
• Age between 8 and 25 years at the time of enrolment.
• Parental or legal guardian's consent for minors (\<18 years) and personal consent for adults.
• Social security affiliation (for France only)

You may not qualify if:

• 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.
• Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest \<85%, and/or SpO2 at exercise \<80%, and/or patient requiring oxygen therapy.
• Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology83.
• Significant systolic right ventricle (sRV) hypertension (sRV pressure \> 50% of systemic systolic pressure).
• 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.
• Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and/or CPET.
• 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).
• Acute or recent (\< 3 months) myocarditis and pericarditis.
• Symptomatic aortic or sub-aortic stenosis (mean gradient \> 50 mmHg).
• Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient \> 20 mmHg.
• 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 risk of aortic dissection (tetralogy of Fallot, pulmonary atresia with IVC, common trunk artery).
• Severe hypertrophic obstructive cardiomyopathy.
• Acute systemic illness.
• Recent (\<3 months) intracardiac thrombus, embolism, or thrombophlebitis.
• Inability to follow instructions and/or complete the questionnaires, as determined by the investigator.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

Saint-Luc University Hospital

Brussels, Belgium

NOT YET RECRUITING

University Hospital of Montpellier - Arnaud de Villeneuve Hospital

Montpellier, 34295, France

RECRUITING

Saint-Pierre Institute

Palavas-les-Flots, 34250, France

RECRUITING

University Hospital of Bordeaux - Haut-Levêque Hospital

Pessac, 33604, France

RECRUITING

Deutsches Herzzentrum München

München, D-80636, Germany

NOT YET RECRUITING

Related Publications (26)

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• Calderon J, Wypij D, Rofeberg V, Stopp C, Roseman A, Albers D, Newburger JW, Bellinger DC. Randomized Controlled Trial of Working Memory Intervention in Congenital Heart Disease. J Pediatr. 2020 Dec;227:191-198.e3. doi: 10.1016/j.jpeds.2020.08.038. Epub 2020 Aug 19.

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• Abassi H, Gavotto A, Picot MC, Bertet H, Matecki S, Guillaumont S, Moniotte S, Auquier P, Moreau J, Amedro P. Impaired pulmonary function and its association with clinical outcomes, exercise capacity and quality of life in children with congenital heart disease. Int J Cardiol. 2019 Jun 15;285:86-92. doi: 10.1016/j.ijcard.2019.02.069. Epub 2019 Mar 1.

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• Morales Mestre N, Reychler G, Goubau C, Moniotte S. Correlation Between Cardiopulmonary Exercise Test, Spirometry, and Congenital Heart Disease Severity in Pediatric Population. Pediatr Cardiol. 2019 Apr;40(4):871-877. doi: 10.1007/s00246-019-02084-5. Epub 2019 Mar 8.

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MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pascal AMEDRO, MD,PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal AMEDRO, MD,PhD

CONTACT

05 57 65 61 09; pascal.amedro@chu-bordeaux.fr

Johanna CALDERON, PhD

CONTACT

johanna.calderon@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 4, 2023
• Study Start: June 3, 2024
• Primary Completion (Estimated): June 3, 2027
• Study Completion (Estimated): June 3, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

FR (3); DE (1); BE (1)