None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Age = 19 years - Patients who have undergone Fontan surgery for complex congenital heart disease - Patients with peak oxygen uptake (VO2peak) = 80% of predicted value during a cardiopulmonary exercise test performed within 1 year prior to study enrollment
Exclusion criteria
Exclusion criteria: -Cases in which cardiopulmonary exercise testing is deemed difficult -High-risk exercise group; cases showing ventricular tachycardia, hypotension, syncope, etc. during baseline cardiopulmonary exercise testing -Active infection -Malignant tumor -Cases with a life expectancy of less than 2 years due to comorbidities -Cases participating in other clinical studies -Cases in which participation in the study is difficult due to cognitive impairment, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VO2peak measured by cardiopulmonary exercise test | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety during cardiopulmonary exercise testing;Changes in indices other than VO2peak during cardiopulmonary exercise test;Changes in respiratory muscle and pulmonary function;Changes in cardiac function assessed by echocardiography;Changes in body composition;Changes in anxiety and depression levels | — |
Countries
Korea, Republic of
Contacts
Sejong General Hospital