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

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

Overview

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.

Interventions

• Other Muscle Your Heart home-based program
  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

Primary outcome measures

• 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 outcome measures (10)

• 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]

Eligibility criteria

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 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.
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque — Pessac

Identifiers

NCT: NCT07115589 · CHUBX 2024/23 · 2024-A01806-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗