Actively Recruiting
High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
Led by Erasmus Medical Center · Updated on 2026-01-21
38
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
D
Dutch Heart Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a 12-week home-based high intensity interval training program can improve exercise capacity in people aged 12 to 45 years who have a congenital heart defect requiring a surgical connection between the right ventricle and pulmonary artery. This includes individuals with truncus arteriosus, pulmonary atresia with ventricular septal defect, severe tetralogy of Fallot, or other forms of pulmonary atresia with biventricular correction. The study aims to identify factors that predict who may benefit from this exercise program. Participants will be randomly assigned to either an intervention group that receives the 12-week exercise program immediately or a control group that undergoes a 12-week control period followed by the exercise program. The exercise involves 30 minutes of high intensity interval training, three times a week, completed at home with digital supervision. Study visits are scheduled before and after the intervention for the intervention group, and before and after both the control and intervention periods for the control group. During study visits, participants will undergo echocardiography, cardiac MRI, cardiopulmonary exercise testing, blood and feces sampling, and complete questionnaires on quality of life and physical activity. Researchers will measure peak oxygen consumption and other heart function parameters at baseline, week 14, week 27 (for the control arm only), and one year. The total participation may last up to one year, with assessments to monitor exercise capacity and heart health over time.
CONDITIONS
Brief Title
High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a congenital heart defect requiring a surgical connection between the right ventricle and pulmonary artery, including truncus arteriosus, pulmonary atresia with ventricular septal defect, severe tetralogy of Fallot, or other forms with biventricular correction
- Aged between 12 and 45 years
- Currently followed at an Academic Center for Congenital Heart Disease such as Erasmus MC Rotterdam or Radboudumc Nijmegen
- Able to provide signed informed consent
You will not qualify if you...
- History of ventricular arrhythmias or inherited arrhythmia syndromes requiring an implantable cardioverter defibrillator
- Left or right ventricular ejection fraction less than 30 percent
- Elite athlete status, defined as national team, Olympian, professional athlete, or exercising 10 or more hours per week
- Cardiovascular lesions requiring intervention as per international guidelines
- Cardiovascular surgery or catheter intervention within the last 6 months
- Cardiovascular medication changes within the last 3 months
- Hospitalization for cardiovascular events within the last 6 months
- Comorbidities or developmental delays that prevent exercise training, such as neuromuscular disease, symptomatic myocardial ischemia, or syndromic diagnoses like trisomy 21
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants in the control arm undergo a 12-week period without intervention while being observed.
1 visit before and 1 visit after the control period
Duration - 12 weeks
Participants engage in a 12-week high intensity interval training program, exercising 30 minutes three times a week at home with digital supervision.
1 visit before and 1 visit after the intervention
Duration - Up to 1 year
Participants are monitored for outcomes including exercise response and quality of life up to 1 year after intervention.
Visits at 1 year post intervention
Trial Site Locations
Total: 2 locations
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Not Yet Recruiting
2
ErasmusMC
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
A
Anouk S Moerdijk, MD
B
Beatrijs Bartelds, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here