Status:
RECRUITING
Congenital Heart Disease Physical Activity Lifestyle Study V.2
Lead Sponsor:
Jamie Jackson
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Heart Defects, Congenital
Cardiovascular Disease Other
Eligibility:
All Genders
15-25 years
Phase:
NA
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) w...
Detailed Description
Current estimates indicate more than 2 million individuals in the United States have CHD. CHD survivors are now living well into adulthood, including those with moderate and complex forms of CHD, who ...
Eligibility Criteria
Inclusion
- 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
- 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 exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)
Key Trial Info
Start Date :
July 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06003023
Start Date
July 18 2023
End Date
June 30 2027
Last Update
April 4 2025
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205