NCT06715137

Microvascular Dysfunction in Adults With Congenital Heart Disease and the Effect of Exercise Training

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this prospective cohort study is to deepen the understanding of the pathophysiology in adults with congenital heart disease (CHD). Through this research, the investigators aim to identify potential strategies to improve the prevention and treatment of these patients. In this context, the effects of exercise training will also be assessed. The main questions it aims to answer are: * Is coronary microvascular dysfunction (MVD) present in adults with diverse types of CHD? * Is peripheral MVD present in adults with diverse types of CHD? * Are coronary and peripheral MVD correlated in adults with diverse types of CHD? * Is microvascular function correlated with inflammation and oxidative stress in adults with diverse types of CHD? * Are inflammation and oxidative stress correlated with ventricular function in adults with diverse types of CHD? * Are MVD and diminished ventricular function interrelated and associated with reduced exercise capacity in adults with diverse types of CHD? * Does exercise training in adults with CHD result in improvements in coronary and peripheral microvascular function, inflammation and oxidative stress, biventricular function, muscle strength, exercise capacity and quality of life? For the last research question, patients were randomized to receive either conventional care or home-based aerobic and strength exercise training.

Conditions

• Congenital Heart Defect
• Congenital Heart Disease
• Microvascular Dysfunction
• Exercise Training
• Oxidative Stress
• Coronary Microvascular Dysfunction
• Peripheral Microvascular Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	Exercise training	Each participant received a personalized rehabilitation schedule combining aerobic interval cycle training and a dynamic strength exercise program, developed to ensure that the participants met the physical activity guidelines. For the aerobic training, the patients cycled for 30-45 minutes on an exercise bike at home 3 times a week. During each training session, the heart rate (HR) was continuously recorded using a chest strap and displayed in a smartphone application. The target HR zones were predefined with alternating intervals of intensive and extensive aerobic training. The program followed a progressive structure with the objective of completing 40 minutes of intensive aerobic training after 16 weeks. In the strength training program, 4 dynamic exercises targeting major muscle groups were performed 3 times a week. Every 2 weeks, these exercises were intensified by altering the starting position or adding extra weight.

Timeline

• Start date: 2021-01-18
• Primary completion: 2024-03-31
• Completion: 2024-05-31
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: Belgium