CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Exercise trainingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06715137
NCT06715137N/ACompleted

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

University Hospital, Antwerp·interventional·Posted Dec 4, 2024·Updated Dec 4, 2024

In Brief

A clinical study evaluating Exercise training for Congenital Heart Defect and 6 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 4, 2024
Enrollment StartJan 18, 2021
Primary CompletionMar 31, 2024
Study CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 1.6 years ago

Interventions

Exercise trainingbehavioral

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.