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

Not Applicable

Active, not recruiting

• Conditions: Congenital Heart Disease

• Registration Number: NCT05853705
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-11
• Study Start: 2024-01-12
• Primary Completion: 2024-12-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Pediatric Cardiac Quality of Life Inventory	1 year	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.
Change in Short Form 36 (SF-36) Health Survey	1 year	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.
Change in secondary Cardiopulmonary Exercise Testing outcome measures	Baseline, up to 12 weeks
Change in sit-to-stand test	Baseline, up to 12 weeks

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States