Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-24 @ 2:27 PM
NCT ID:
NCT04135859
Eligibility Criteria:
Inclusion Criteria:
1. Between the ages of 18-25 (if 18, must no longer be in high school and no longer living at home)
2. Are diagnosed with moderate or complex structural congenital heart disease
3. Live within 120 miles of Nationwide Children's Hospital
Exclusion Criteria:
1. Do no speak or write proficiently in English
2. Have cognitive impairments that would interfere with the completion of study procedures
3. Are diagnosed with a genetic syndrome (e.g., Downs, Marfans)
4. Have been engaged in a formal exercise program within the past 6 months
5. Underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months
6. Are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity
7. Are unable to complete a treadmill-based exercise stress test
8. Are currently pregnant
9. Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)
10. \>150 min/weekday of moderate-to-vigorous physical activity per the accelerometer
11. Do not have access or a device for videoconferencing with the coach
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT04135859
Study Brief:
Protocol Section:
NCT04135859