NCT05853705

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 10 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
BEHAVIORAL	Strong Hearts Exercise Program	The participant will either begin at the easiest variation of each strength exercise (level A), or will be placed at a specific level for each strength exercise based on their assessment with physical therapy. Participants can progress to the next level of difficulty of a specific strength exercise based on their rating of perceived exertion (RPE) with the opportunity to move to the next level if they have RPE score of 6 or less and if their heart rates are at goal. Each participant will be provided with heart rate ranges based on the heart rate reserve (HRR) method using their baseline resting and peak heart rates obtained during their cardiopulmonary exercise testing (CPET) or percent predicted heart rate based on age if CPET is not available. HRR goals will be set individually for patients and adjusted per protocol to guide effort.

Timeline

• Start date: 2024-01-12
• Primary completion: 2024-12-05
• Completion: 2024-12-05
• First posted: 2023-05-11
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States