Neuro-cardiac Rehabilitation Program of Children, Adolescents, and Young Adults With Congenital Heart Disease
Study Details
Study Description
Brief Summary
Neurodevelopmental impairments and physical deconditioning are the leading causes of long-term morbidity in patients with congenital heart disease (CHD). These public health issues worsen during school age and adolescence and have major consequences on the quality of life (QoL) of children and their families. A holistic rehabilitation program, using a combined neuro-cardiac intervention, has the potential for the long-term improvement of their physical and mental health outcomes.
A novel neuro-cardiac rehabilitation program is proposed, in a multicentre randomized controlled trial, measuring the impact of a holistic "heart-brain" intervention on the quality of life, physical health and mental health of young patients with CHD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study hypothesis is that the change in health-related quality of life (HRQoL), as measured by the self-reported PedsQL4.0 (Pediatric Quality of Life Inventory) total score's variation from baseline (M0, enrolment) to follow-up (M12, 12 months after enrolment), will be greater in the group of participants with CHD assigned to the intervention (group 1) compared to those assigned to the standard of care (group 2).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Neurocardiac rehabilitation program Patients receiving a neurocardiac rehabilitation program for 12 weeks |
Other: Neurocardiac rehabilitation program
Patients receiving a neurocardiac rehabilitation program for 12 weeks.
|
| Active Comparator: Standard of care Patients receiving the standard of care - No intervention during the neurocardiac rehabilitation program |
Other: Standard of care
No intervention during the neurocardiac rehabilitation program
|
Outcome Measures
Primary Outcome Measures
- Total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire [between Month 0 and Month 12]
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."
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient with a CHD of moderate to great complexity as defined in the 2019 American Heart Association/American College of Cardiology guidelines (AHA/ACC guidelines).
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History of cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life.
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Age between 8 and 25 years at the time of enrolment.
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Parental or legal guardian's consent for minors (<18 years) and personal consent for adults.
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Social security affiliation (for France only)
Exclusion Criteria:
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Unstable and/or severe heart failure: severe heart failure (class IV New York Heart Association (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%).
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Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest <85%, and/or SpO2 at exercise <80%, and/or patient requiring oxygen therapy.
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Pulmonary hypertension as defined by the 2020 European Society of Cardiology (ESC) guidelines, whatever the aetiology.
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Significant systolic right ventricle (sRV) hypertension (sRV pressure > 50% of systemic systolic pressure).
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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 Cardiopulmonary exercise test (CPET), occurrence or aggravation of any supraventricular or ventricular arrhythmia during exercise and/or CPET.
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Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and/or CPET.
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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).
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Acute or recent (< 3 months) myocarditis and pericarditis.
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Symptomatic aortic or sub-aortic stenosis.
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Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient > 20 mmHg.
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Dilatation of the aorta (aortic root > 40 mm in adults, > 2 Z-score in children85 (http://www.parameterz.com/sites/aortic-root).
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Severe hypertrophic obstructive cardiomyopathy diagnosed by non-echocardiography.
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Acute systemic illness.
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Recent (<3 months) intracardiac thrombus, embolism, or thrombophlebitis.
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Inability to follow instructions and/or complete the questionnaires, as determined by the investigator.
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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.
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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).
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Patient with a previously diagnosed severe psychiatric disorder requiring hospitalization and/or continuous specialized care by a psychiatrist, as determined by the investigator.
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Patients who benefited from a cardiac rehabilitation within the 12 months preceding the enrolment.
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Patients who benefited from a computerized executive function or attention training such as Cogmed Working Memory Program within the 12 months preceding the enrolment.
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For female patients: pregnancy, pregnancy plan, or breastfeeding woman following questioning of the patient.
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Patients deprived of liberty due to an ongoing legal procedure, adult's patient under guardianship or curatorship or unable to personally express their consent.
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Any other clinical and/or pharmacological treatment that is believed to interfere with the study or the optimal clinical care.
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In certain cases, enrolment can be delayed for 6 months if the patient has Introduction of a concomitant new therapy or a major change in treatment (, i.e., initiation or withdrawal of any psychotropic medication including methylphenidate, benzodiazepines, and mood stabilizers) within the 6 months preceding the enrolment.
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Patient participating or wishing to participate at an interventional clinical research (therapeutic or dispositive treatment)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Bordeaux
Investigators
- Study Director: Pascal AMEDRO, MD,PhD, University Hospital, Bordeaux
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHUBX 2021/66