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

Sponsor
Erasmus Medical Center
Study ID
NCT06771687
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jan 13, 2025
Start date
Jan 16, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
    This arm receives the 12-week exercise intervention, with a study visit before and after the intervention.
  • No Intervention: Control
    This arm starts with a 12-week control period, after which the participants will also receive the 12-week exercise intervention. Participants will have a study visit before and after the control period and after the intervention. For the primary outcome parameter, only the control period will be used to compare to the intervention. For the secondary outcome parameters (predictors for response), also the intervention period of the control group will be used.

Primary Outcome Measure

Peak oxygen consumption [ Time Frame: At baseline, week 14, week 27 (control arm only) and 1 year ]

Central Contacts

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