Digital Exercise for Congenital Heart Disease

Overseen By Zoe Lincoln, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Lymphatic disorders, Arrhythmias, Pacemaker, Heart transplant, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

200 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 Digital Exercise Intervention for Congenital Heart Disease?

Research shows that digital exercise interventions, like e-Health encouragements and telemedicine exercise programs, can improve physical fitness and quality of life in children and adolescents with congenital heart disease by making exercise more accessible and engaging. ^{1 2 3 4 5}

Is digital exercise safe for people with congenital heart disease?

Research suggests that digital exercise interventions, such as e-Health and telemedicine programs, are generally safe for people with congenital heart disease. These programs have been tested for feasibility and safety, showing promise in improving physical activity and health-related quality of life without significant safety concerns. ^{1 4 5 6 7}

How is the Digital Exercise Intervention treatment different from other treatments for congenital heart disease?

The Digital Exercise Intervention is unique because it uses eHealth and mHealth technologies to provide remote, interactive exercise programs tailored to children and adolescents with congenital heart disease. This approach increases access to physical activity and exercise programs, especially for those in low-resource settings, by using mobile and internet technology to deliver personalized encouragements and monitor progress. ^{1 4 5 7 8}

What is the purpose of this trial?

The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention. The main questions it aims to answer are: * Does a home-based, digital intervention increase physical activity (PA) in youth with the FC compared to enhanced usual care? * Does a home-based, digital intervention increase physical fitness in youth with the FC compared to enhanced usual care? * Do multi-level factors (medical, neurodevelopmental, sociodemographic, neighborhood) impact the effectiveness of the digital intervention? Researchers will compare participants in the enhanced usual care arm to those in the exercise intervention arm to see if the digital intervention is effective. All participants will wear a PA tracker for 12 months and complete testing at baseline, 6 months, and 12 months. In addition, participants in the exercise intervention arm will complete a 6-month exercise intervention with the following components: * aerobic exercise * resistance exercise * engagement strategies

Research Team

Elizabeth Goldmuntz, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for children aged 10-17 with Fontan Circulation, a type of congenital heart disease. They should be able to participate in physical activities and follow the study's procedures. Specific medical, neurodevelopmental, sociodemographic, or neighborhood factors may affect eligibility.

Inclusion Criteria

I can follow all study instructions and procedures.

I have a Fontan circulation.

I am a girl aged 11 or older or menstruating and have a negative pregnancy test.

Exclusion Criteria

I have heart rhythm problems caused by exercise or that are not under control.

I cannot complete a standard exercise test due to physical or cognitive limitations.

Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Initial testing and a two-week run-in period to assess baseline fitness levels

2 weeks

Treatment

Participants in the exercise intervention arm complete a 6-month digital exercise intervention including aerobic and resistance exercises

6 months

Baseline, 6 months, and 12 months testing

Monitoring

Participants are monitored for changes in physical activity and fitness outcomes

5.5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Digital Exercise Intervention

Trial Overview The trial studies a home-based digital exercise program designed to increase physical activity and fitness in these children compared to usual care. It includes aerobic and resistance exercises along with engagement strategies over six months.

Participant Groups

Group I: Digital Exercise Intervention Experimental Treatment 1 Intervention

The exercise intervention arm includes access to a digital application to receive the following over the 6-month intervention: * personalized plans for aerobic-based PA * personalized resistance exercise sessions * engagement strategies.

Group II: Enhanced Usual Care Active Control 1 Intervention

The enhanced usual care arm will receive their usual care in addition to a passive physical activity tracker device. No intervention materials will be delivered to these participants over the course of their enrollment in the study.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Findings from Research

Children and adolescents with congenital and acquired heart disease (CHD) often do not get enough physical activity, but exercise interventions can significantly improve their health outcomes.

The cardiac exercise therapeutics (CET) model offers a structured approach to promote physical activity through various levels of intervention, including clinical settings and remote technologies, which could enhance access to exercise programs, especially in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ehealth technology in cardiac exercise therapeutics for pediatric patients with congenital and acquired heart conditions: a summary of evidence and future directions. White, DA., Layton, AM., Curran, T., et al.[2023]

The FORCE tool, which classifies patients with congenital heart disease (CHD) based on hemodynamic factors, was successfully implemented in 98% of cases, demonstrating its feasibility for risk stratification in exercise prescriptions.

No adverse events were reported during nearly 1000 exercise training sessions, indicating that the FORCE tool is safe for guiding cardiac rehabilitation in patients under 22 years old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FORCE Risk Stratification Tool for Pediatric Cardiac Rehabilitation and Fitness Programs. Gauthier, N., Reynolds, L., Curran, T., et al.[2023]

A 5-year study involving 40 children with congenital heart defects showed that those who participated in a simple home exercise program during the first 3 months after surgery achieved normal physical fitness levels.

In contrast, children who did not engage in the postoperative training program remained significantly less active than their healthy peers, highlighting the importance of early exercise intervention for improving long-term physical activity in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative exercise training develops normal levels of physical activity in a group of children following cardiac surgery. Longmuir, PE., Tremblay, MS., Goode, RC.[2018]

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]

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]

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 48 patients with adult congenital heart disease, peak oxygen consumption (pVO2) measured by smartwatches showed a strong correlation with pVO2 measured during cardiopulmonary exercise tests (CPET), indicating that smartwatches can effectively monitor exercise capacity in this population.

The changes in pVO2 over time were also well correlated between the smartwatch and CPET measurements, suggesting that smartwatches can reliably track improvements or declines in exercise capacity in patients with complex heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peak oxygen consumption by smartwatches compared with cardiopulmonary exercise test in complex congenital heart disease. Tran, T., Steiner, JM., Venkateswaran, A., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

ehealth technology in cardiac exercise therapeutics for pediatric patients with congenital and acquired heart conditions: a summary of evidence and future directions. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

FORCE Risk Stratification Tool for Pediatric Cardiac Rehabilitation and Fitness Programs. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Postoperative exercise training develops normal levels of physical activity in a group of children following cardiac surgery. [2018]

4. England pubmed.ncbi.nlm.nih.gov

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

5. 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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Web-Based Motor Intervention to Increase Health-Related Physical Fitness in Children With Congenital Heart Disease: A Study Protocol. [2020]

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

Peak oxygen consumption by smartwatches compared with cardiopulmonary exercise test in complex congenital heart disease. [2023]