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

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.

Study Overview

• Status: Terminated
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Behavioral: Strong Hearts Exercise Program

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in peak rate of oxygen volume consumption (VO2) on Cardiopulmonary Exercise Testing	Baseline, up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sit-to-stand test		Baseline, up to 12 weeks
Change in Pediatric Cardiac Quality of Life Inventory	The Pediatric Cardiac Quality of Life Inventory generates 3 scores (total, disease impact subscale, and psychosocial impact subscale). Each subscale has a maximum of 50 points and their sums yields the total score. Higher scores indicate better perceived health-related quality of life.	1 year
Change in Short Form 36 (SF-36) Health Survey	The Short Form 36 Health Survey consists of 8 subscales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health). The survey will be scored using the two step RAND scoring process. The first step scores each question on a scale from 0 (worst) to 100 (best) and represents the percentage of total possible score achieved. The second scoring step, takes the average of all the questions in each subscale to create the 8 scores.	1 year
Change in secondary Cardiopulmonary Exercise Testing outcome measures		Baseline, up to 12 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Reid C Chamberlain, MD, MSCI, Duke UMC

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Actual): December 5, 2024
• Study Completion (Actual): December 5, 2024

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Child; Adult
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: Pro00111958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No