App-Enabled Exercise Program for Congenital Heart Disease

Overseen By Stefany Olague, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Hypertension, Arrhythmia, Heart failure, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-12 weeks

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Strong Hearts Exercise Program for congenital heart disease?

Research shows that exercise programs, including those using new technologies like telemedicine, can improve physical fitness and quality of life in children with congenital heart disease. These programs help increase access to exercise, especially for those in remote areas, and have been shown to improve both physical and psychosocial outcomes. ^{1 2 3 4 5}

Is the app-enabled exercise program safe for people with congenital heart disease?

Research on exercise programs for people with congenital heart disease suggests that these interventions can improve physical fitness without causing harmful changes to the heart. However, the safety of home-based and telemedicine exercise programs, which offer convenience and access, is still being studied, and more data is needed to fully understand their safety. ^{1 2 3 5 6}

How is the Strong Hearts Exercise Program treatment different from other treatments for congenital heart disease?

The Strong Hearts Exercise Program is unique because it uses an app-enabled approach to deliver a home-based exercise program specifically designed for individuals with congenital heart disease. This program leverages telemedicine and eHealth technologies to provide real-time monitoring and personalized exercise encouragement, making it more accessible and convenient for patients, especially those in remote areas, compared to traditional facility-based cardiac rehabilitation programs. ^{1 2 3 4 6}

What is the purpose of this trial?

The overall goal of this program is to create a remote, mobile application enabled exercise program for patients with Congenital Heart Disease (CHD). Pilot trials will consist of a remote exercise program with app-embedded exercise modules designed to promote and encourage safe and healthy exercise habits across a range of CHD anatomies. This app-enabled program will allow for real time data collection integrating wearable devices, as well as compliance and safety monitoring to enhance research capabilities. The app-enabled program will be versatile and may be applied in the future to patients with non-cardiac conditions.

Research Team

Reid C Chamberlain, MD, MSCI

Principal Investigator

Duke UMC

Eligibility Criteria

This trial is for people aged 10-50 with Congenital Heart Disease (CHD), who have an Android (6.0+) or Apple smartphone (iOS 13+). It's not for pregnant individuals, those with disabilities that prevent exercise, uncontrolled high blood pressure, poorly managed arrhythmia, or unstable heart failure.

Inclusion Criteria

Android or Apple smartphone that meets the operating systems below with the ability to download applications from either Google Play or the Apple store

I have congenital heart disease and am between 10 and 50 years old.

Apple: iPhone Operating System (iOS) 13 or higher

Exclusion Criteria

I have a disability that stops me from exercising.

My high blood pressure is not controlled even with medication.

I have a heart rhythm problem that is not well-controlled.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a remote, app-enabled exercise program consisting of strength and aerobic exercises for four to twelve weeks, guided by exercise videos and monitored via wearable fitness trackers.

4-12 weeks

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including the Short Form 36 Health Survey and Pediatric Cardiac Quality of Life Inventory.

1 year

Treatment Details

Interventions

• Strong Hearts Exercise Program

Trial Overview The Strong Hearts Exercise Program is being tested to see if a mobile app can help patients with CHD exercise safely. The app includes exercise modules and uses wearable devices to track real-time data on compliance and safety.

Participant Groups

Group I: Exercise Group Experimental Treatment 1 Intervention

Participants will participate in a remote, app-enabled exercise program consisting of strength and aerobic exercises for four to twelve weeks. They will perform the exercises 3-5 times a week at home guided by exercise videos in the app. The exercise sessions will increase in frequency throughout the training regimen. The videos will include athletes demonstrating how to perform each exercise safely, and provide tips for optimal form and breathing. Participants will wear wearable fitness trackers and monitor their heart rates during exercise sessions.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Food and Drug Administration (FDA)

Collaborator

Trials

184

Recruited

1,553,000+

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]

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]

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. England pubmed.ncbi.nlm.nih.gov

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

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

The effect of exercise training on cardiac remodelling in children and young adults with corrected tetralogy of Fallot or Fontan circulation: a randomized controlled trial. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Aerobic fitness change with time in children with congenital heart disease: A retrospective controlled cohort study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Long-term effects of physical training on cardiopulmonary exercise parameters in young patients with congenital heart diseases. [2023]

6. 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]