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

Duke University

Status: Active, not recruiting

Conditions: Congenital Heart Disease

Treatments: Behavioral: Strong Hearts Exercise Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05853705

Pro00111958

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 10 to 50 years old

Volunteers: No Healthy Volunteers

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 ability to download applications from either Google Play or the Apple store

  • Android: 6.0 or higher
  • Apple: iPhone Operating System (iOS) 13 or higher

Exclusion criteria

• Physical or mental disabilities preventing exercise participation
• Uncontrolled systemic hypertension (symptomatic or greater than Stage 2 hypertension while on therapy)
• Poorly controlled arrhythmia
• Clinically unstable heart failure
• Known pregnancy at the time of enrollment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Exercise Group

Experimental group

Description:

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.

Treatment:

Behavioral: Strong Hearts Exercise Program