Home-based Cardiovascular Rehabilitation in Young Patients With Congenital Heart Disease: the "Mu… (NCT07115589) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Home-based Cardiovascular Rehabilitation in Young Patients With Congenital Heart Disease: the "Muscle Your Heart" Program
France21 participantsStarted 2026-01-01
Plain-language summary
Standard cardiovascular rehabilitation is performed in a medical care and rehabilitation centre. However, it may not be adapted to the patient's profile and there are few medical care and rehabilitation centres specialized in pediatric cardiology. The objective of this study is to evaluate the impact of cardiovascular rehabilitation entirely at home on the physical fitness of young patients with congenital heart disease.
Who can participate
Age range8 Years – 25 Years
SexALL
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Inclusion Criteria:
* Indication for home cardiovascular rehabilitation given by the referring cardiologist as part of routine care.
* Follow-up for congenital heart disease in the ACC-CHD classification.
* Patient aged 8 to 25 years at the time of inclusion.
* Consent of the adult patient or the parents or legal guardians of the minor patient.
* Social security affiliation (excluding AME).
* VO2max and/or SV1 \< -1.64 z-score for patients aged 8 to 17 years or VO2max \< 80% and/or SV1 \< 55% of theoretical VO2max for patients aged 18 to 25 years
Exclusion Criteria:
* Unstable and/or severe heart failure: severe heart failure (NYHA functional class IV), recent decompensated heart failure requiring hospitalisation and/or any significant change in medication (\< 3 months before inclusion), systolic ventricle dysfunction (left ventricular or systemic ventricular ejection fraction \< 50%).
* Severe hypoxemia: 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 aetiology.
* Significant systolic right ventricle (sRV) hypertension (Srv pressure \> 50% of systemic systolic pressure).
* Uncontrolled arrhythmia: symptomatic arrhythmia treated or untreated at rest and/or during exercise, treated arrhythmia with sustained supraventricular or ventricular tachycardia on ECG monitoring or during exercise and/or CPET, occurrence or aggravation of…
What they're measuring
1
Evolution of the maximal oxygen consumption (VO2max) obtained in the cardiopulmonary exercise test (CPET)
Timeframe: baseline and at the end of the 3-month program (week 12)