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.
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
Exclusion Criteria
Treatment Details
Interventions
- Strong Hearts Exercise Program (Behavioral Intervention)
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Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Mary E. Klotman
Duke University
Chief Executive Officer since 2017
MD from Duke University School of Medicine
Michelle McMurry-Heath
Duke University
Chief Medical Officer since 2020
MD from Duke University School of Medicine
Food and Drug Administration (FDA)
Collaborator
Dr. Patrizia Cavazzoni
Food and Drug Administration (FDA)
Chief Medical Officer
MD from Harvard Medical School
Dr. Martin A. Makary
Food and Drug Administration (FDA)
Chief Executive Officer
MD from Sidney Kimmel Medical College, MPH from Harvard T.H. Chan School of Public Health