RECRUITING

Congenital Heart Disease Physical Activity Lifestyle Study V.2

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention

Quick Facts

Study Start:2023-07-18
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06003023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 15-25 years
  2. * Diagnosed with moderate or complex structural CHD
  3. * Actively receiving care from a cardiologist at Nationwide Children's Hospital (NCH) or Ohio State University (OSU)
  1. * Unable to speak and read proficiently in English
  2. * Have a diagnosis of a genetic syndrome that impacts multiple organ systems
  3. * Have cognitive impairments that would interfere with completing study measures
  4. * Have been engaged in a formal exercise program within the past 6 months,
  5. * Have participated in the intervention arm of the previous CHD-PAL Study
  6. * Have undergone open-heart surgery or had a valve replacement in the last 3 months
  7. * Are unable to complete an exercise stress test using a treadmill
  8. * Are pregnant
  9. * Are prohibited to engage in at least moderate levels of physical activity by their cardiologist
  10. * Engage in \>30 minutes of moderate-to-vigorous physical activity per day, on average per accelerometer
  11. * Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)

Contacts and Locations

Study Contact

Jamie L Jackson, PhD
CONTACT
6147223585
jamie.jackson2@nationwidechildrens.org
Jessica Bowman, MS
CONTACT
6143553499
jessica.bowman2@nationwidechildrens.org

Principal Investigator

Jamie L Jackson, PhD
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

Nationwide Children's Hospital
Columbus, Ohio, 43205
United States

Collaborators and Investigators

Sponsor: Jamie Jackson

  • Jamie L Jackson, PhD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-18
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-07-18
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • congenital heart disease
  • physical activity
  • adolescents
  • young adults

Additional Relevant MeSH Terms

  • Heart Defects, Congenital
  • Cardiovascular Disease Other