Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease (Strong Hearts App)

Last updated: August 3, 2026
Sponsor: Duke University
Overall Status: Terminated

Phase

N/A

Condition

Congenital Heart Disease

Heart Disease

Pentalogy Of Cantrell

Treatment

Strong Hearts Exercise Program

Clinical Study ID

NCT05853705
Pro00111958
  • Ages 10-50
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Repaired or unrepaired Congenital Heart Disease (CHD)

  • Between ages 10 and 50, inclusive, at time of consent

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

  • Android: 6.0 or higher

  • Apple: iPhone Operating System (iOS) 13 or higher

Exclusion

Exclusion Criteria:

  • Physical or mental disabilities preventing exercise participation

  • Uncontrolled systemic hypertension (symptomatic or greater than Stage 2 hypertensionwhile on therapy)

  • Poorly controlled arrhythmia

  • Clinically unstable heart failure

  • Known pregnancy at the time of enrollment

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: Strong Hearts Exercise Program
Phase:
Study Start date:
January 12, 2024
Estimated Completion Date:
December 05, 2024