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

NCT ID: NCT05853705

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-12
• Study Completion Date: 2024-12-05

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Group

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.

Group Type: EXPERIMENTAL

Strong Hearts Exercise Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reid C Chamberlain, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Duke UMC

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00111958

Identifier Type: -

Identifier Source: org_study_id