Lifestyle Program for Congenital Heart Disease

(CHD-PALS V2 Trial)

Overseen By Jessica Bowman, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Jamie Jackson

Disqualifiers: Genetic syndromes, Cognitive impairments, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 20 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a lifestyle program helps young people with congenital heart disease (CHD) maintain their health. The trial compares two approaches: one focuses on exercise using a Fitbit and health education, while the other includes motivational strategies to enhance physical activity. It suits individuals aged 15-25 with moderate or complex CHD who are not currently in a formal exercise program and are receiving care at Nationwide Children's Hospital or Ohio State University. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could improve health outcomes for young people with CHD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this lifestyle intervention program is safe for adolescents and young adults with congenital heart disease?

Research shows that the Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Program is manageable for participants. Studies have found that it includes safe exercises supervised by trained health professionals. Participants receive a Fitbit and a personalized exercise plan, and they meet regularly with health coaches.

These studies did not find any serious side effects, indicating the program's safety for young adults with congenital heart disease. For those considering participation, it's important to know that the program was improved from an earlier version to enhance health benefits. This means it has been tested and refined to better support exercise and healthy living. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Program for Congenital Heart Disease because it offers a unique, personalized approach to managing congenital heart disease. Unlike traditional treatments that often focus on medication or surgical interventions, this program emphasizes physical activity and lifestyle changes tailored to each individual. In the LIV-CHD arm, participants use a Fitbit and receive a customized exercise plan, along with health education on topics like sleep and stress management. The CHD-PAL arm adds a twist by incorporating cognitive behavioral strategies based on the Theory of Planned Behavior to boost physical activity and healthy habits. This trial represents a shift toward empowering patients to take charge of their health through guided lifestyle changes.

What evidence suggests that this lifestyle program is effective for congenital heart disease?

Research shows that exercise programs can greatly benefit the heart health of young people with congenital heart disease (CHD). In this trial, participants will join different treatment arms. The "Living Well with Congenital Heart Disease (LIV-CHD) Intervention" arm focuses on using a Fitbit and health education to promote a healthy lifestyle. Meanwhile, the "Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention" arm emphasizes cognitive behavioral strategies to increase physical activity. A previous study found that participants who followed a structured exercise plan spent more time engaging in moderate to vigorous physical activities. This type of activity is crucial for maintaining heart health and fitness. Additionally, personalized exercise plans with regular guidance have proven effective in promoting healthy lifestyle habits. These habits are essential for improving long-term heart health in people with CHD. ^{1 2 3 4 6}

Who Is on the Research Team?

Jamie L Jackson, PhD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for young people aged 15-25 with moderate to complex congenital heart disease, who are patients at Nationwide Children's Hospital or Ohio State University. They must be able to speak and read English well, not have had recent major heart surgery, and can't already be very physically active or in another exercise program.

Inclusion Criteria

Currently seeing a heart doctor at Nationwide Children's Hospital or Ohio State University.

I have been diagnosed with a moderate or complex heart defect.

I am between 15 and 25 years old.

Exclusion Criteria

Your heart doctor says you can't do at least moderate physical activity.

You have been in a regular exercise program in the last 6 months.

I have not had open-heart surgery or valve replacement in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 20-week videoconferencing-administered intervention including 9 sessions to increase physical activity and healthy living

20 weeks

9 virtual sessions

Interim Follow-up

Participants' physical activity and TPB mechanisms are assessed 20 weeks post-intervention

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Congenital Heart Disease Physical Activity Lifestyle Study V.2

Trial Overview The study tests a lifestyle program that includes education on healthy living, monitoring physical activity levels, personalized exercise plans, and interventions based on the Theory of Planned Behavior to improve cardiovascular health in adolescents and young adults with congenital heart disease.

How Is the Trial Designed?

Group I: Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention Experimental Treatment 4 Interventions

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.

Group II: Living Well with Congenital Heart Disease (LIV-CHD) Intervention Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Jamie Jackson

Lead Sponsor

Trials

3

Recruited

240+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

In a study of 786 patients with congenital heart disease (CHD), those who reported engaging in health-enhancing physical activity (HEPA) had significantly better exercise capacity and health-related quality of life (HrQoL) compared to inactive individuals.

The findings suggest that using the International Physical Activity Questionnaire (IPAQ) can effectively identify patients with CHD who are at lower risk for impaired HrQoL and exercise capacity, although it should not replace more precise measurement tools like accelerometers or cardiopulmonary exercise testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in adults with congenital heart disease and associations with functional outcomes. Müller, J., Amberger, T., Berg, A., et al.[2022]

This study involves 216 adolescents aged 13-16 with surgically corrected congenital heart disease, testing the impact of a year-long e-Health intervention on their physical fitness and quality of life.

The intervention includes weekly tailored encouragements via SMS and mobile apps, aiming to enhance physical activity, with the hypothesis that it will improve fitness levels measured by maximal oxygen uptake (Vo2) after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and rationale for the PREVAIL study: effect of e-Health individually tailored encouragements to physical exercise on aerobic fitness among adolescents with congenital heart disease--a randomized clinical trial. Klausen, SH., Mikkelsen, UR., Hirth, A., et al.[2017]

In a study of 747 adults with coronary heart disease (CHD), exercise capacity was found to be significantly lower than reference values, with men achieving 58.7% and women 66.3% of expected capacity.

About 20-25% of patients did not meet recommended physical activity levels, and both men and women reported lower health-related quality of life scores compared to reference values, highlighting the need for individualized exercise prescriptions to improve their overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise capacity, physical activity, and health-related quality of life in adults with CHD. Ashman Kröönström, L., Cider, Å., Zetterström, AK., et al.[2021]

In a study of 146 adults with congenital heart disease, those who engaged in frequent moderate physical activity (at least twice a week) showed a significant improvement in exercise capacity, measured by an increase in pVO2, compared to those with low or occasional activity levels over a median follow-up of 13.2 months.

Patients who increased their frequency of physical activity were more likely to experience clinically significant improvements in exercise capacity, with 27.3% showing a notable increase in pVO2, compared to only 11% of those who maintained or decreased their activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity is associated with improved aerobic exercise capacity over time in adults with congenital heart disease. Tikkanen, AU., Opotowsky, AR., Bhatt, AB., et al.[2021]

In a study of 471 adults with congenital heart disease (CHD), those with low physical activity levels (PAL) were older, had more symptoms and comorbidities, and reported a lower quality of life compared to those with high PAL.

The study found that patient-reported outcomes (PROs), particularly the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, were more strongly associated with PAL than age or medical factors, suggesting that these measures can help tailor physical activity recommendations for CHD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes are associated with physical activity level in adults with congenital heart disease. Bay, A., Dellborg, M., Berghammer, M., et al.[2022]

In a study of 75 patients with congenital heart disease (CHD) and 42 matched controls, both groups showed similar proportions of individuals meeting the recommended physical activity level (PAL) for health, indicating that patients with CHD can maintain adequate activity levels.

The International Physical Activity Questionnaire (IPAQ) overestimated physical activity levels compared to objective measurements from the Actiheart monitor, but it still proved useful in identifying patients with insufficient activity, especially given its higher negative predictive value in patients with CHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adults with congenital heart disease overestimate their physical activity level. Larsson, L., Johansson, B., Wadell, K., et al.[2022]

Adults with complex congenital heart disease often face barriers to physical activity, such as lack of encouragement during childhood, which can lead to negative attitudes towards exercise in adulthood.

Identifying enablers, like support and knowledge about their exercise capacity, is crucial for healthcare professionals to help these individuals engage in physical activity safely and effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enablers and barriers for being physically active: experiences from adults with congenital heart disease. Bay, A., Lämås, K., Berghammer, M., et al.[2021]

Adults with congenital heart disease generally have lower exercise capacity compared to the general population, but regular exercise is safe and can provide significant physical and psychosocial benefits.

Despite common health fears, evidence supports that exercise training is beneficial and should be encouraged, with tailored recommendations based on individual conditions and risks, particularly regarding the type and intensity of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and Benefits of Exercise Training in Adults With Congenital Heart Disease. Chaix, MA., Marcotte, F., Dore, A., et al.[2022]

Youth with congenital heart disease (CHD) often have reduced exercise capacity and lower quality of life, highlighting the need for effective exercise interventions, particularly home-based programs that can be monitored via telemedicine.

A new 12-week randomized crossover trial is being conducted to evaluate the effectiveness of a home-based high-intensity interval training program using a video game-linked cycle ergometer, which may provide better cardiorespiratory benefits compared to traditional moderate-intensity exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. Spence, C., Khoo, N., Mackie, A., et al.[2023]

A study involving 40 adults with moderate to severe congenital heart disease showed that home-based, self-selected exercise training is safe and well-tolerated, with no participants discontinuing due to exercise-related issues.

Participants who engaged in the exercise program experienced a significant improvement in their exercise capacity, as indicated by a 1.7 ml∙kg∙min-1 increase in peak VO2, while the control group showed no significant change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of home-based, self-selected exercise training in symptomatic adults with congenital heart disease: A prospective, randomised, controlled trial. van Dissel, AC., Blok, IM., Hooglugt, JQ., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06003023

Congenital Heart Disease Physical Activity Lifestyle Study ... This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors. Detailed Description.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34951444/

A Randomized Clinical Trial Demonstrating Feasibility and ... Purpose: The current study aims to (a) determine the feasibility/acceptability of the Congenital Heart Disease Physical Activity Lifestyle (CHD ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40298651/

Congenital Heart Disease Physical Activity Lifestyle ... - PubMed Congenital Heart Disease Physical Activity Lifestyle Intervention (CHD-PAL): A Randomized Clinical Trial Among Young Adults With Congenital ...

4. trialx.com trialx.com/clinical-trials/listings/275327/congenital-heart-disease-physical-activity-lifestyle-study-v2/

Congenital Heart Disease Physical Activity Lifestyle Study ... 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) ...

5. trialstoday.org trialstoday.org/trial/NCT06003023

Congenital Heart Disease Physical Activity Lifestyle Study ... This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9274981/

A Randomized Clinical Trial Demonstrating Feasibility and ... The current study aims to (a) determine the feasibility/acceptability of the Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) intervention among ...