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

NCT05853705 | Terminated

• 1 other identifier: Pro00111958
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

Child; Adult

Outcome Measures

Primary Outcomes (1)

• Change in peak rate of oxygen volume consumption (VO2) on Cardiopulmonary Exercise Testing

  Baseline, up to 12 weeks

Secondary Outcomes (4)

• Change in Pediatric Cardiac Quality of Life Inventory

  1 year

• Change in Short Form 36 (SF-36) Health Survey

  1 year

• Change in sit-to-stand test

  Baseline, up to 12 weeks

• Change in secondary Cardiopulmonary Exercise Testing outcome measures

  Baseline, up to 12 weeks

Study Arms (1)

Exercise Group

EXPERIMENTAL

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.

Behavioral: Strong Hearts Exercise Program

Interventions

Strong Hearts Exercise Program 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.

Exercise Group

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Reid C Chamberlain, MD, MSCI

  Duke UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 11, 2023
• Study Start: January 12, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)