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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 45
Healthy Volunteers: f
View:

• Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right ventricle to pulmonary artery conduit, including patients with:

‣ Truncus arteriosus

⁃ Pulmonary atresia with ventricular septum defect

⁃ Severe tetralogy of Fallot

⁃ Other forms of pulmonary atresia with biventricular correction

• Age 12 to 45 years.

• Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen).

• Signed informed consent.

Locations
Other Locations
Netherlands
Radboudumc
NOT_YET_RECRUITING
Nijmegen
ErasmusMC
RECRUITING
Rotterdam
Contact Information
Primary
Anouk S Moerdijk, MD
a.moerdijk@erasmusmc.nl
+31107036264
Backup
Beatrijs Bartelds, MD, PhD
b.bartelds@erasmusmc.nl
+31107036264
Time Frame
Start Date: 2025-01
Estimated Completion Date: 2028-03
Participants
Target number of participants: 38
Treatments
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.
Sponsors
Collaborators: Dutch Heart Foundation, Radboud University Medical Center
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov