Eligibility Module

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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: 2025-12-25 @ 2:21 AM
Ignite Modification Date: 2025-12-25 @ 2:21 AM
NCT ID: NCT06826534
Eligibility Criteria: INCLUSION CRITERIA * Patients aged of 10-21 years at enrollment * Parent/legal guardian available for consent (if applicable), and patient available for assent and consent * History of anthracycline exposure +/- radiation * Currently in remission, with at least 6 months off chemotherapy * Able to perform CPET * Baseline CPET with VO2 \<80% (at start of study, or CPET at CHLA after January 2020) * Smartphone compatible with Fitbit (own or parent/legal guardian's) * Ability to complete and send diary and Fitbit information on a weekly basis * Ability to participate in monthly virtual check-in visits * Baseline activity prior to intervention \<30min/day, 2x/week EXCLUSION CRITERIA * Inability to obtain consent/assent * Unable to accurately perform quality of life survey independently * No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery * Contraindication to moderate activity (\>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC/AHA Stage D) * Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies * Unable to perform mild activity for at least 0.5h/day and at least 2x/week * Unable to come to hospital for study visits at 0 and 6 months * Unable to complete study-related surveys * Unable to complete and send diary and Fitbit information on a weekly basis * Unable to check-in monthly on virtual platform * On beta blockade * Pregnancy
Healthy Volunteers: False
Sex: ALL
Minimum Age: 0 Years
Maximum Age: 21 Years
Study: NCT06826534
Study Brief:
Protocol Section: NCT06826534