Home-based Cardiovascular Rehabilitation in Young Patients With Congenital Heart Disease: the "Muscle Your Heart" Program

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-25
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Muscle Your Heart home-based program

    Other intervention

    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

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: fully home-based cardiovascular rehabilitation programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

First ventilatory anaerobic threshold obtained at the CPET

Time frame
at week 0 and at week 14 (last visit after the end of the rehabilitation program)
2

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

Time frame
at week 0 and at week 14 (last visit after the end of the rehabilitation program)
3

Maximum oxygen pulse obtained at the CPET

Time frame
at week 0 and at week 14 (last visit after the end of the rehabilitation program)
4

Maximum workload in watt obtained at the CPET

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

Other outcomes

Sponsors and contacts

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