CHD - Congenital Heart DiseaseMuscletoncoeurNCT07115589
Home-based Cardiovascular Rehabilitation in Young Patients With Congenital Heart Disease: the "Muscle Your Heart" Program
A study testing Muscle Your Heart home-based program in people with CHD - Congenital Heart Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- CHD - Congenital Heart Disease
- What is being tested?
- Muscle Your Heart home-based program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 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.
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- 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.
- Inability to undergo the physical intervention: inability to physically exercise, any invasive medical intervention occurring within 6 months preceding the inclusion or scheduled during the 3-month study period (such as cardiac surgery, catheter-based intervention, orthopedic surgery, chemotherapy for cancer, or any other significant medical treatment or intervention, as determined by the investigator).
- For female patients: pregnancy, planning to become pregnant, or breastfeeding woman following questioning of the patient.
- Any other clinical and/or pharmacological treatment that is believed to interfere with the study or the optimal clinical care.
- Patients deprived of their liberty due to ongoing legal procedure, adult patients under guardianship or curatorship, or unable to personally express their consent.
- Patients who have benefited from cardiovascular rehabilitation in the 12 months preceding inclusion.
- Patient participating or wishing to participate in any interventional clinical research (drug trial, medical device, non-drug trial).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque
Pessac, France, 33604
Pr Pascal AMEDRO, MD,PhD, 5 57 65 61 09 ext. 33, pascal.amedro@chu-bordeaux.fr
Pr Pascal AMEDRO, MD,PhD
About this study
Official title: Impacts of Home-based Cardiovascular Rehabilitation on the Physical Fitness of Children, Adolescents and Young Adults With Congenital Heart Disease: the "Muscle Your Heart" Program
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.
Read the detailed description
Young patients with congenital heart disease suffer from physical deconditioning [1], negatively impacting the quality of life [2, 3], due in particular to obstacles stated by the patient's social environment [4, 5]. For this, there is cardiovascular rehabilitation, however, it may not be adapted to the patient's profile and there are few specialized centres in France. In the sense, the QUALIREHAB program, tested in a randomized controlled trial, was created. This 3-month hybrid program (at the patient's home and in a medical care and rehabilitation centre), combining adapted physical activity, patient therapeutic education and psychosocial support, has demonstrated positive effects on quality of life, level of physical activity, knowledge of the disease, body mass index and mental health [6].
However, this program has limitations, including the need for a medical care and rehabilitation centre near the patient's home.
This study, evaluating the impact of a 3-month cardiovascular rehabilitation program entirely at home, will improve this program by taking into account its limitations and will apply it to real life, without all the human, financial and material resources of a randomized controlled trial.
- Conditions
- CHD - Congenital Heart Disease
- Being tested
- Muscle Your Heart home-based program
- Keywords
- Congenital heart disease, Paediatric, Cardiovascular rehabilitation, Adapted physical activity, Therapeutic patient education
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| fully home-based cardiovascular rehabilitation program | Experimental | 3-month cardiovascular rehabilitation program entirely at home, combining adapted physical activity, therapeutic education and psychosocial support Receives: Other: Muscle Your Heart home-based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the maximal oxygen consumption (VO2max) obtained in the cardiopulmonary exercise test (CPET)
Measured: baseline and at the end of the 3-month program (week 12)
Secondary outcomes (10)
First ventilatory anaerobic threshold obtained at the CPET
Measured: 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
Measured: at week 0 and at week 14 (last visit after the end of the rehabilitation program)
Maximum oxygen pulse obtained at the CPET
Measured: at week 0 and at week 14 (last visit after the end of the rehabilitation program)
Maximum workload in watt obtained at the CPET
Measured: 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)
This is a validated questionnaire for patients aged between 2 and 25, comprising 23 items covering 4 different areas: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). The proxy questionnaire, designed for parents and those close to the child, assesses parents' perceptions of the quality of life associated with their child's state of health. Each item is scored from 0, when there is no problem, to 4, when there is always a problem.
Measured: at week 0 and at week 14
Level of physical activity assessed with questionnaires for 8 to 17-year-old
The questionnaire for children aged 8 to 17 years included is the CAPAS-Q (Children and adolescents physical activity and sedentary questionnaire). The CAPAS-Q was developed as a clinical and field tool to provide indicators of physical activity and sedentary behaviour. The CAPAS-Q allows indicators such as the duration and intensity of physical activity to be addressed in different contexts (school, outside school, sports and leisure activities, transport). Physical activity is scored from 1 (inactive) to 4 (very active) and sedentary lifestyle is scored from 1 (not sedentary, active enough) from 6 (sedentary).
Measured: at week 0 and at week 13
Level of physical activity assessed with questionnaires for over 18-year-old
For patients over 18 years of age, the short version of the IPAQ (International physical activity questionnaire) was chosen. This questionnaire assesses overall physical activity and sedentary behaviour over the last 7 days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or on public transport. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high.
Measured: at week 0 and at week 13
Level of physical activity assessed with accelerometers and questionnaires
Patients will wear an accelerometer for 7 days, to objectively measure their level of physical activity. This tool must be removed during aquatic activities or during activities involving physical contact.
Measured: at week 0 and at week 13
Muscle strength of the upper limbs assessed by handgrip test
The Handgrip test consists of squeezing the handle of a hand dynamometer. The patient chooses their preferred hand and squeezes the handle as hard as they can for 3 seconds. The task was repeated 3 times, with 30 seconds rest between trials. The best trial is used as an indicator of maximum upper limb strength.
Measured: at week 0 and at week 14
Muscle strength of lower limbs assessed Standing long jump test
For the lower limbs, the Standing long jump test is used. The patient stands with feet together and jumps forward as far as possible. After the jump, the patient must remain motionless with both feet on the ground. If he loses his balance or touches an object, he must repeat the jump. The distance between the jump line and the heels is measured. The patient performs 2 trials, the longest distance being used as an indicator of maximum lower limb strength.
Measured: at week 0 and at week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHD - Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pr Pascal AMEDRO, MD,PhD, Study director, CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115589
- Sponsor's protocol ID
- CHUBX 2024/23
- Other IDs
- 2024-A01806-41
- Acronym
- Muscletoncoeur
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Home-based Cardiovascular Rehabilitation on the Physical Fitness of Children, Adolescents and Young Adults With Congenital Heart Disease: the "Muscle Your Heart" Program
- ClinicalTrials.gov ID
- NCT07115589
- Acronym / sponsor ID
- Muscletoncoeur / CHUBX 2024/23
- Conditions
- CHD - Congenital Heart Disease
- Keywords
- Congenital heart disease, Paediatric, Cardiovascular rehabilitation, Adapted physical activity, Therapeutic patient education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Young patients with congenital heart disease suffer from physical deconditioning [1], negatively impacting the quality of life [2, 3], due in particular to obstacles stated by the patient's social environment [4, 5]. For this, there is cardiovascular rehabilitation, however, it may not be adapted to the patient's profile and there are few specialized centres in France. In the sense, the QUALIREHAB program, tested in a randomized controlled trial, was created. This 3-month hybrid program (at the patient's home and in a medical care and rehabilitation centre), combining adapted physical activity, patient therapeutic education and psychosocial support, has demonstrated positive effects on quality of life, level of physical activity, knowledge of the disease, body mass index and mental health [6].
However, this program has limitations, including the need for a medical care and rehabilitation centre near the patient's home.
This study, evaluating the impact of a 3-month cardiovascular rehabilitation program entirely at home, will improve this program by taking into account its limitations and will apply it to real life, without all the human, financial and material resources of a randomized controlled trial.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fully home-based cardiovascular rehabilitation program | Experimental | Other: Muscle Your Heart home-based program3-month cardiovascular rehabilitation program entirely at home, combining adapted physical activity, therapeutic education and psychosocial support |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (22 listed)
- 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 any supraventricular or ventricular arrhythmia during exercise and/or CPET.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Your Heart home-based program2 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 | Other | fully home-based cardiovascular rehabilitation program |
Primary outcome
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)
10 secondary outcomes
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)
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)
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)
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)
Quality of life assessed with Pediatric Quality of Life questionnaire (PedsQL) questionnaire (self and proxy)
Time frame: at week 0 and at week 14
Level of physical activity assessed with questionnaires for 8 to 17-year-old
Time frame: at week 0 and at week 13
Level of physical activity assessed with questionnaires for over 18-year-old
Time frame: at week 0 and at week 13
Level of physical activity assessed with accelerometers and questionnaires
Time frame: at week 0 and at week 13
Muscle strength of the upper limbs assessed by handgrip test
Time frame: at week 0 and at week 14
Muscle strength of lower limbs assessed Standing long jump test
Time frame: at week 0 and at week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Amedro, P., Gavotto, A., Guillaumont, S., Bertet, H., Vincenti, M., De La Villeon, G., et al. (2018). Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart (British Cardiac Society), 104(12), 1026-1036.Link provided by the sponsor.
- Amedro, P., Dorka, R., Moniotte, S., Guillaumont, S., Fraisse, A., Kreitmann, B., et al. (2015). Quality of Life of Children with Congenital Heart Diseases: A Multicenter Controlled Cross-Sectional Study. Pediatric cardiology, 36(8), 1588-1601.Link provided by the sponsor.
- Amedro, P., Picot, M. C., Moniotte, S., Dorka, R., Bertet, H., Guillaumont, S., et al. (2016). Correlation between cardio-pulmonary exercise test variables and health-related quality of life among children with congenital heart diseases. InternationalLink provided by the sponsor.
- Longmuir, P. E., \& McCrindle, B. W. (2009). Physical activity restrictions for children after the Fontan operation: disagreement between parent, cardiologist, and medical record reports. American heart journal, 157(5), 853-859Link provided by the sponsor.
- Swan, L., \& Hillis, W. S. (2000). Exercise prescription in adults with congenital heart disease: a long way to go. Heart (British Cardiac Society), 83(6), 685-687Link provided by the sponsor.
- Craig, C. L., Marshall, A. L., Sjöström, M., Bauman, A. E., Booth, M. L., Ainsworth, B. E., Pratt, M., et al. (2003). International physical activity questionnaire: 12-country reliability and validity. Medicine and science in sports and exercise, 35(8Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pr Pascal AMEDRO, MD,PhD study director
CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Your Heart home-based program in people with CHD - Congenital Heart Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pr Pascal AMEDRO, MD,PhD (5 57 65 61 09 ext. 33, pascal.amedro@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.