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

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

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

Treatments tested in this trial

  • High intensity interval training

Treatment groups

38 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Erasmus Medical Center

Lead sponsor

Dutch Heart Foundation

Collaborator

Radboud University Medical Center

Collaborator