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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT04195451
Eligibility Criteria:
Inclusion Criteria:
* 8-19 years of age
* Fontan palliation
* Ability to fast overnight
* Cardiac clearance to exercise by primary cardiologist
* Presence of an adult at home during exercise sessions for patients \<14 years old
* English-speaking patient.
Exclusion Criteria:
* NYHA Class IV (severe heart failure)
* Acute illness within the past three months
* Active protein losing enteropathy (albumin \<2.5 mg/dL)
* Implanted pacemaker
* Cognitive delay deemed severe enough to inhibit the ability to follow the exercise
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
19 Years
Study:
NCT04195451
Study Brief:
Protocol Section:
NCT04195451