NCT06003023 · Jamie Jackson
Congenital Heart Disease Physical Activity Lifestyle Study V.2
(CHD-PALS V2)
What this study is about
The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the effectiveness 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.
View original scientific 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.
Interventions
BEHAVIORAL
Physical Activity Monitoring
A physical activity monitor (Fitbit) will be provided to participants in both arms.
BEHAVIORAL
Tailored Exercise Prescription
Participants in both arms will receive the results of their exercise stress test, which includes information on the duration, frequency, and intensity of their physical activity.
BEHAVIORAL
Healthy Lifestyle Education
Participants in both arms will receive information on healthy living, including topics such as physical activity, sleep, stress management, and diet.
BEHAVIORAL
Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior
Participants randomized to the CHD-PAL arm will receive coaching to: 1) change attitudes towards physical activity; 2) increase perceptions of other people's approval of physical activity; 3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance and will be accompanied by goal-setting.
Primary outcome measures
Moderate to Vigorous Physical Activity (MVPA)
Time frame: Baseline to Weeks 20, 40, and 80
Number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Columbus, Ohio
Collaborators
National Institute of Nursing Research (NINR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations