RecruitingNot Applicable

Congenital Heart Disease Physical Activity Lifestyle Study V.2

United States144 participantsStarted 2023-07-18

Plain-language 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.

Who can participate

Age range

15 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Moderate to Vigorous Physical Activity (MVPA)

Timeframe: Baseline to Weeks 20, 40, and 80

Trial details

NCT IDNCT06003023

SponsorJamie Jackson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-30

Contact for this trial

Jamie L Jackson, PhD

6147223585 jamie.jackson2@nationwidechildrens.org

View on ClinicalTrials.gov More Heart Defects, Congenital trials