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Recruiting NCT06003023

Congenital Heart Disease Physical Activity Lifestyle Study V.2

Trial Parameters

Condition Heart Defects, Congenital
Sponsor Jamie Jackson
Study Type INTERVENTIONAL
Phase N/A
Enrollment 144
Sex ALL
Min Age 15 Years
Max Age 25 Years
Start Date 2023-07-18
Completion 2026-04-01
Interventions
Physical Activity MonitoringTailored Exercise PrescriptionHealthy Lifestyle Education

Brief Summary

The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.

Eligibility Criteria

Inclusion Criteria: * Between the ages of 15-25 years * Diagnosed with moderate or complex structural CHD * Actively receiving care from a cardiologist at Nationwide Children's Hospital (NCH) or Ohio State University (OSU) Exclusion Criteria: * Unable to speak and read proficiently in English * Have a diagnosis of a genetic syndrome that impacts multiple organ systems * Have cognitive impairments that would interfere with completing study measures * Have been engaged in a formal exercise program within the past 6 months, * Have participated in the intervention arm of the previous CHD-PAL Study * Have undergone open-heart surgery or had a valve replacement in the last 3 months * Are unable to complete an exercise stress test using a treadmill * Are pregnant * Are prohibited to engage in at least moderate levels of physical activity by their cardiologist * Engage in \>30 minutes of moderate-to-vigorous physical activity per day, on average per accelerometer * Have contraindications for e

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