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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app-based exercise program, the Strong Hearts Exercise Program, designed for individuals with Congenital Heart Disease (CHD), a condition affecting the heart's structure from birth. The program includes strength and aerobic exercises that participants can perform at home while using wearable fitness trackers to monitor heart rates. The goal is to safely promote healthy exercise habits for those with CHD, using the app to collect data and ensure safety. Individuals with CHD who have a smartphone and can exercise without physical or mental limitations might be suitable for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance exercise options for those 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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this app-enabled exercise program is safe for patients with Congenital Heart Disease?

Research shows that the Strong Hearts Exercise Program is safe for participants. Studies have found that similar exercise programs improve heart health without serious safety issues. For example, a previous program led to significant heart health benefits and reported no major problems. The app includes safety features such as real-time heart rate monitoring and instructional videos on safe exercise techniques. These features help participants exercise safely at home. Overall, the program is well-received and emphasizes promoting safe and healthy exercise habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Strong Hearts Exercise Program for congenital heart disease because it offers a unique, app-enabled approach that allows participants to exercise safely at home. Unlike traditional cardiac rehabilitation programs that often require in-person sessions, this program uses guided videos and wearable fitness trackers to monitor progress and ensure participant safety. The flexibility to exercise remotely could increase accessibility and adherence, potentially leading to better outcomes for individuals with congenital heart disease.

What evidence suggests that this app-enabled exercise program is effective for Congenital Heart Disease?

Research has shown that exercise programs can benefit people with Congenital Heart Disease (CHD). One study found that a 6-month home-based exercise program improved the physical health of children with CHD. Another study demonstrated that guided exercise programs enhanced both physical and mental well-being in adults with CHD. In this trial, participants will engage in the Strong Hearts Exercise Program, which aims to provide these benefits through a home-use app. Early results from other versions of the Strong Hearts program have been positive, showing increased physical activity and improved overall health. This suggests that the app-based program could enable people with CHD to exercise safely. ^{1 4 6 7 8}

Who Is on the Research Team?

Reid C Chamberlain, MD, MSCI

Principal Investigator

Duke UMC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05853705/strong-hearts-a-remote-app-enabled-exercise-program-for-patients-with-congenital-heart-disease-strong-hearts-app?q=congenital%20heart%20disease

Strong Hearts: A Remote, App-Enabled, Exercise Program ... The overall goal of this program is to create a remote, mobile application enabled exercise program for patients with Congenital Heart ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10845703/

Effects of 6-month customized home-based exercise on ... Among 420 screened CHD children, 192 were enrolled and randomly assigned at a 1:1 ratio to receive a 6-month intervention (30 min daily ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06567184

Evaluation of the Strong Hearts Urban Program The aim of this study is to assess the feasibility and preliminary effectiveness of the adapted Strong Hearts (SH) intervention to improve weight status, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666668521000860

Supported exercise programme for adults with Congenital ... The aim of this study is to determine the feasibility of introducing a supported exercise programme to develop physical and psychological wellbeing in adults ...

5. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-024-01670-y

Process evaluation findings from Strong Hearts, Healthy ... SHHC-2.0 was a 24-week cardiovascular disease prevention program that was effective in improving physical activity and nutrition behaviors and clinical ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36958944/

Effects of the Strong Hearts program after a major ... Conclusions: The 9-week structured program resulted in significant cardiovascular benefit to patients with CVD by reducing cardiac risk factors, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7311302/

The Strong Hearts, Healthy Communities Program 2.0 Furthermore, recent data have shown a widening disparity in CVD mortality rates between urban and rural areas in the past 2 decades, reflecting observed ...

8. openheart.bmj.com openheart.bmj.com/content/12/1/e003091

The effect of strength training interventions on people with ... This systematic review indicates a moderate improvement in muscle strength by ST alone, with a small improvement in peak V̇O 2 in people with ConHD.