Clinical trial NCT06003023: Congenital Heart Disease Physical Activity Lifestyle Study V.2
Official title: Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Defects, Congenital
Cardiovascular Disease Other
Keywords: congenital heart disease
physical activity
adolescents
young adults
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-08-21
Enrollment: 144
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study includes 2 possible conditions to which participants are randomized: (1) Control: Fitbit + tailored exercise prescription + information on living well with CHD (2) Fitbit + tailored exercise prescription + theory-driven health coaching sessions.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Baseline to Weeks 20, 40, and 80
Secondary outcomes:
measure: Physical Activity Enjoyment/Engagement Scale (Attitudes)
timeFrame: Baseline to Weeks 10, 20, 40, and 80
measure: Affective Attitudes for Physical Activity Scale (Attitudes)
timeFrame: Baseline to Weeks 10, 20, 40, and 80
measure: Physical Activity Norms Measure (Social Norms)
timeFrame: Baseline to Weeks 10, 20, 40, and 80
measure: Family and Partner Support for Physical Activity Engagement Measure (Social Norms)
timeFrame: Baseline to Weeks 10, 20, 40, and 80
measure: Perceived Control for Physical Activity Engagement Measure (Perceived Control)
timeFrame: Baseline to Weeks 10, 20, 40, and 80
measure: Exercise Confidence Survey (Perceived Control)
timeFrame: Baseline to Weeks 10, 20, 40, and 80
Other outcomes:
measure: Cardiorespiratory Fitness-Volume of Oxygen Consumption (Peak VO2)
timeFrame: Baseline to Week 20
measure: Cardiorespiratory Fitness- Metabolic Equivalents (METs)
timeFrame: Baseline to Week 20
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Jamie L Jackson, PhD
role: PRINCIPAL_INVESTIGATOR
References: