Congenital Heart Disease Physical Activity Lifestyle Study V.2 (CHD-PALS V2)

Jamie Jackson

Status: Enrolling

Conditions: Cardiovascular Disease Other; Heart Defects, Congenital

Treatments: Behavioral: Healthy Lifestyle Education; Behavioral: Tailored Exercise Prescription; Behavioral: Physical Activity Monitoring; Behavioral: Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06003023

STUDY00002759

R01NR020423 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Current estimates indicate more than 2 million individuals in the United States have CHD. CHD survivors are now living well into adulthood, including those with moderate and complex forms of CHD, who previously did not survive childhood. However, adult CHD survivors are now encountering cardiovascular comorbidities, such as coronary disease and hypertension, costing more than $3.16 billion annually in hospitalizations and resulting in premature death. The benefits of physical activity for preventing coronary artery disease and other cardiac comorbidities are well-known. For CHD survivors, the benefits of physical activity for preventing morbidity and premature mortality have also been emphasized. Despite strong evidence for physical activity preventing and treating acquired cardiovascular comorbidities among CHD survivors, adolescents and young adults (AYAs) with CHD do not meet recommended activity levels. The CHD-PAL intervention aims to provide individualized guidance on safe forms of physical activity that is delivered by trained allied health interventionists.

The CHD-PAL intervention is informed by the Theory of Planned Behavior (TPB) which has been used as a framework for lifestyle interventions, including among adults with heart failure and adolescents. Additionally, the CHD-PAL intervention implements goal-setting (or developing action plans) and self-monitoring, both of which are key for enacting the behavior within the TPB.

Investigators will randomize (1:1) 144 AYAs (ages 15-25) with moderate and complex CHD who spend <=30 minutes/day in moderate to vigorous physical activity (MVPA) to 1 of 2 arms: CHD-PAL or attention control (Control). Both arms will receive a Fitbit® and a tailored exercise prescription. Those in CHD-PAL will also receive a 20-week videoconferencing-administered intervention that includes 9, 20 to 30-minute sessions designed to increase positive attitudes towards, subjective norms for, and perceived control for engaging in physical activity. Self-monitoring and goal-setting will also be encouraged to help enact behavior change. Controls will receive the same number/frequency of videoconferencing contacts to discuss the Fitbit and exercise prescription, as well as general healthy living, without addressing the TPB hypothesized mechanisms. Controls will also not be directed to self-monitor or engage in goal-setting. All participants will receive text messages from interventionists to either reinforce session content and inquire about progress towards goals (CHD-PAL) or to remind participants to wear the Fitbit (Control). Randomization will be stratified by gender and age using randomly varying block sizes of 4 to 6. MVPA, as measured with a research-grade accelerometer, will be assessed at baseline (T1), post-intervention (T3; 20 weeks after baseline), interim follow-up (T4; 20 weeks post-intervention), and follow-up (T5; 40 weeks post-intervention). TPB mechanisms will be similarly assessed, with the addition of an interim assessment during the intervention (T2; 10 weeks after baseline). Cardiorespiratory fitness (peak volume of oxygen consumption (VO2) and metabolic equivalent (METs)), as assessed via stress testing, will be measured at T1 and T3 as exploratory secondary outcomes.

The primary aim is to determine the efficacy of the CHD-PAL intervention on change in time spent in moderate to vigorous physical activity (MVPA) for AYAs with moderate and complex CHD. The secondary aim is to explore change in the TPB mechanisms and their relevance to change in MVPA. The tertiary aim is exploring the impact of CHD-PAL on cardiorespiratory fitness.

Enrollment: 144 estimated patients

Sex: All

Ages: 15 to 25 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Living Well with Congenital Heart Disease (LIV-CHD) Intervention

Active Comparator group

Description:

In LIV-CHD, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on how to use the Fitbit along with health education pertinent to living a healthy lifestyle (e.g., sleep hygiene, stress management). Goal-setting and other cognitive behavioral strategies for health behavior change will not be discussed in this arm. Participants in the attention control arm will also receive text messages reminding them to wear their Fitbit.

Treatment:

Behavioral: Tailored Exercise Prescription

Behavioral: Physical Activity Monitoring

Behavioral: Healthy Lifestyle Education

Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention

Experimental group

Description:

In CHD-PAL, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on cognitive behavioral strategies, grounded in the Theory of Planned Behavior, to increase physical activity and healthy living. Participants in the intervention arm will also receive text motivational messages relevant to session content, as well as reminders to wear their Fitbit.

Treatment:

Behavioral: Physical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior

Behavioral: Tailored Exercise Prescription

Behavioral: Physical Activity Monitoring

Behavioral: Healthy Lifestyle Education