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Search / Trial NCT06003023

Congenital Heart Disease Physical Activity Lifestyle Study V.2

Launched by JAMIE JACKSON · Aug 17, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Congenital Heart Disease Physical Activity Adolescents Young Adults

ClinConnect Summary

The Congenital Heart Disease Physical Activity Lifestyle Study (CHD-PALS) V.2 is a research study designed to help young people aged 15 to 25 who have heart defects known as congenital heart disease (CHD). The goal of this study is to see if a special program encouraging physical activity can improve their heart health and overall well-being. This program builds on an earlier study and aims to support young adults as they transition to independent living while managing their heart condition.

To participate in this study, individuals must be between 15 and 25 years old and diagnosed with moderate to complex heart defects. They should also be receiving care from a heart specialist at Nationwide Children's Hospital or Ohio State University. Participants will be involved in activities that promote a healthier lifestyle, and they will be closely monitored to ensure their safety throughout the study. It's important to note that some individuals may not be eligible to join, such as those who have recently had heart surgery, are unable to engage in exercise, or are already very active. Overall, this study aims to provide valuable insights into how physical activity can benefit young people with congenital heart disease.

Gender

ALL

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 exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)

About Jamie Jackson

Jamie Jackson is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With expertise in overseeing and managing clinical studies, Jamie Jackson prioritizes rigorous adherence to regulatory standards and ethical guidelines, ensuring the integrity and reliability of trial data. By fostering collaborations with healthcare professionals and research institutions, Jamie Jackson aims to facilitate innovative treatments and contribute to the development of new therapies across various therapeutic areas. Their focus on transparency and patient safety underscores a holistic approach to clinical trial management.

Locations

Columbus, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Jamie L Jackson, PhD

Principal Investigator

Nationwide Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported