Trial Summary
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.
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
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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.
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Treatment Details
Interventions
- Strong Hearts Exercise Program (Behavioral Intervention)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Exercise GroupExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
Food and Drug Administration (FDA)Collaborator