Congenital Heart Disease Physical Activity Lifestyle Study V.2
Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention
Jamie Jackson
144 participants
Jul 18, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria11
- 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)
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Interventions
A physical activity monitor (Fitbit) will be provided to participants in both arms.
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.
Participants in both arms will receive information on healthy living, including topics such as physical activity, sleep, stress management, and diet.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06003023