High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit

ConditionsCongenital Heart Disease Truncus Arteriosus Pulmonary Atresia Tetralogy of Fallot

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-45

SponsorErasmus Medical Center

About this trial

The goal of this clinical trial is to learn if a specific type of exercise training (high intensity interval training) can improve exercise capacity in people with a congenital heart defect that required the creation of a new connection between the right ventricle and pulmonary artery. This includes people with a truncus arteriosus, pulmonary atresia with a ventricular septal defect or severe tetralogy of Fallot. This study focuses on people aged 12 to 45 years. The main questions it aims to answer are:

* Can a 12-week home-based high intensity interval exercise training program increase the exercise capacity? * Can factors that predict whether or not the exercise training program can increase the exercise capacity in specific people be identified?

Researchers will compare the results from the intervention group to the control group. Participants will be assigned to one of these two groups at inclusion. The control group will also receive the intervention, after the control period.

Participants will:

* Participate in a 12-week home-based exercise training program (3x30 minutes a week, digitally supervised); * Attend 2 or 3 study visits (which partially is standard care) (2 visits for the intervention group, 3 visits for the control group); * Each study visit includes: echocardiography, magnetic resonance imaging (MRI) of the heart, cardiopulmonary exercise testing (CPET), blood and feces sampling, and questionnaires on quality of life and physical activity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Truncus arteriosus

Pulmonary atresia with ventricular septum defect

Severe tetralogy of Fallot

Other forms of pulmonary atresia with biventricular correction

Disqualifiers

Ventricular arrhythmias and/or channelopathy.

Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes.

Left ventricular ejection fraction and/or right ventricular ejection fraction less than 30 percent.

Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h/week, according to definition in 2020 European Society of Cardiology Guidelines for Sports Cardiology and Exercise in Patients with Cardiovascular Disease).

Trial design

Design model

Crossover

Treatments tested in this trial

High intensity interval training
Behavioral
A 12-week high intensity interval training program, with 30 minutes of exercise three times a week. The trainings can be completed at home and will be digitally supervised.

Treatment groups

38 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes