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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a home-based digital exercise program, known as the Digital Exercise Intervention, can increase physical activity and fitness in children with Fontan Circulation compared to their usual care. Participants will use a digital app for guided exercise plans and motivation strategies. The trial will also examine how factors such as medical history and neighborhood environment influence the program's success. Children who have undergone the Fontan procedure and can manage the study activities may be suitable candidates. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance future care for children with Fontan Circulation.

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 digital exercise intervention is safe for children with congenital heart disease?

Research has shown that digital exercise programs are generally safe for young people with heart conditions. One study found that these programs not only help children with heart issues become more active but also prove safer than relying solely on regular doctor visits. Another review highlighted that digital exercise programs offer a safe way for young people with congenital heart disease (a heart condition present from birth) to exercise at home. Overall, evidence suggests that digital exercise programs are well-tolerated and can safely increase physical activity in children with heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Exercise Intervention for congenital heart disease because it offers a novel, tech-driven approach to managing this condition. Unlike traditional treatments that focus on medication or surgery, this intervention leverages a digital app to provide personalized aerobic and resistance exercise plans. What sets it apart is its engagement strategies, which aim to boost patient adherence and motivation, something often challenging with standard care. This innovative use of technology could redefine how physical activity is prescribed and managed for congenital heart disease patients.

What evidence suggests that this digital exercise intervention is effective for increasing physical activity and fitness in youth with congenital heart disease?

Research has shown that digital exercise programs can help children with congenital heart disease (CHD) become more active and fit. In this trial, participants in the Digital Exercise Intervention arm will access a digital application that provides personalized plans for aerobic-based physical activity and resistance exercise sessions. Studies have found that these exercise programs, including online ones, can improve both the mental and physical health of young people with heart conditions. For instance, one study found that children who participated in supervised online exercise sessions felt less anxious and experienced a better quality of life. Experts in heart health support digital exercise platforms because they offer a convenient and effective way to aid recovery. Overall, digital exercise programs are promising tools for increasing activity levels and fitness in kids with CHD. ^{1 2 3 4 6}

Who Is on the Research Team?

Elizabeth Goldmuntz, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10272804/

ehealth technology in cardiac exercise therapeutics for ... Although physical activity (PA) and exercise interventions are effective at improving short- and long-term physiological and psychosocial outcomes in youth ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X23016288

Review Exploring the Promise of Telemedicine Exercise ... In this review, we highlight the existing evidence basis for exercise interventions in youth with CHD, explore the promise of incorporating telemedicine home- ...

3. publications.aap.org publications.aap.org/pediatricsopenscience/article/1/2/1/201448/Feasibility-Safety-and-Efficacy-of-Pediatric

Feasibility, Safety, and Efficacy of Pediatric Cardiac ... Eighty-seven percent of participants completed all 12 supervised sessions. Virtual PCTR improved scores for anxiety (P = .007), quality of life ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001150

Digital Technologies in Cardiac Rehabilitation: A Science ... This American Heart Association science advisory was assembled to guide the development and implementation of digital cardiac rehabilitation interventions.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08019-7

The effects of telerehabilitation in adults with complex ... - Trials Accumulated evidence suggests that exercise training exerts beneficial effects on people with congenital heart conditions.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06626672

Study Details | NCT06626672 | Digital Health Promotion for ... This study will develop and test a 12-week digital lifestyle intervention for children (ages 8-13) and their guardians, using a Garmin Vivofit Jr. 2 wearable.