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

Trial Summary

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 data supports the effectiveness of the treatment Congenital Heart Disease Physical Activity Lifestyle Intervention?

Research shows that physical activity is linked to better exercise capacity and quality of life in adults with congenital heart disease. Regular physical activity can improve aerobic fitness and may reduce health issues over time. ^{1 2 3 4 5}

Is the Lifestyle Program for Congenital Heart Disease safe for humans?

Research shows that home-based, self-selected exercise training is safe for adults with congenital heart disease, suggesting that similar lifestyle programs are generally safe for humans. ^{3 4 5 6 7}

How is the CHD-PAL treatment different from other treatments for congenital heart disease?

The CHD-PAL treatment is unique because it focuses on a lifestyle intervention that encourages physical activity specifically tailored for individuals with congenital heart disease, rather than relying on medication or surgery. This approach aims to improve exercise capacity and overall health through a structured physical activity program, potentially using telemedicine to enhance accessibility and convenience. ^{5 6 8 9 10}

What is the purpose of this trial?

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.

Research Team

Jamie L Jackson, PhD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Physical activity in adults with congenital heart disease and associations with functional outcomes. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity is associated with improved aerobic exercise capacity over time in adults with congenital heart disease. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Patient reported outcomes are associated with physical activity level in adults with congenital heart disease. [2022]

4. United States 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. [2017]

5. Ireland pubmed.ncbi.nlm.nih.gov

Adults with congenital heart disease overestimate their physical activity level. [2022]

6. Netherlands 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. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Exercise capacity, physical activity, and health-related quality of life in adults with CHD. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Enablers and barriers for being physically active: experiences from adults with congenital heart disease. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Risks and Benefits of Exercise Training in Adults With Congenital Heart Disease. [2022]