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

NCT06771687 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-01-21

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Heart Disease
  • Truncus Arteriosus
  • Pulmonary Atresia
  • Tetralogy of Fallot

Interventions

BEHAVIORAL

High intensity interval training

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.

Sponsors & Collaborators

  • Dutch Heart Foundation

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Beatrijs Bartelds, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2027-10-31
Completion
2028-10-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06771687 on ClinicalTrials.gov