NCT07115589

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

Same day

First QC Date

June 3, 2025

Last Update Submit

August 6, 2025

Conditions

CHD - Congenital Heart Disease

Keywords

Congenital heart diseasePaediatricCardiovascular rehabilitationAdapted physical activityTherapeutic patient education

Outcome Measures

Primary Outcomes (1)

  • Evolution of the maximal oxygen consumption (VO2max) obtained in the cardiopulmonary exercise test (CPET)

    baseline and at the end of the 3-month program (week 12)

Secondary Outcomes (10)

  • First ventilatory anaerobic threshold obtained at the CPET

    at week 0 and at week 14 (last visit after the end of the rehabilitation program)

  • Ventilatory efficiency (VE/VCO2 slope) obtained at the CPET

    at week 0 and at week 14 (last visit after the end of the rehabilitation program)

  • Maximum oxygen pulse obtained at the CPET

    at week 0 and at week 14 (last visit after the end of the rehabilitation program)

  • Maximum workload in watt obtained at the CPET

    at week 0 and at week 14 (last visit after the end of the rehabilitation program)

  • Quality of life assessed with Pediatric Quality of Life questionnaire (PedsQL) questionnaire (self and proxy)

    at week 0 and at week 14

  • +5 more secondary outcomes

Study Arms (1)

fully home-based cardiovascular rehabilitation program

EXPERIMENTAL

3-month cardiovascular rehabilitation program entirely at home, combining adapted physical activity, therapeutic education and psychosocial support

Other: Muscle Your Heart home-based program

Interventions

Muscle Your Heart home-based programOTHER

2 one-hour sessions of adapted physical activity per week - HIIT and free adapted physical activity - 1 one-hour monthly therapeutic patient education session - A dedicated platform - Adapted physical activity educators - Dedicated education therapeutic nurses

fully home-based cardiovascular rehabilitation program

Eligibility Criteria

Age8 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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 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 (blood pressure at rest during the consultation \> 140/90 mmHg in adults, \> 95th percentile in children).
  • Acute or recent myocarditis and pericarditis (\< 3 months).
  • Symptomatic aortic or subaortic 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 children) (http://www.parameterz.com/sites/aortic-root) except in the case of repaired CHD with dilatation of the aorta inherent in the malformation and without risk of aortic dissection (tetralogy of Fallot, transposition of the great vessels, pulmonary atresia IVC, common trunk artery).
  • Severe obstructive hypertrophic cardiomyopathy.
  • Acute systemic disease.
  • Recent intracardiac thrombus (\< 3 months), embolism or thrombophlebitis.
  • Inability to follow instructions and/or home rehabilitation and/or answer questionnaires, as determined by the investigator.
  • Absolute contraindications for CPET: fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction, and patients with mental impairment leading to inability to cooperate.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque

Pessac, France, 33604, France

Location

Related Links

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Pr Pascal AMEDRO, MD,PhD

    CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque

    STUDY DIRECTOR

Central Study Contacts

Pr Pascal AMEDRO, MD,PhD

CONTACT

5 57 65 61 09pascal.amedro@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2025

First Posted

August 11, 2025

Study Start

January 1, 2026

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

FR(1)