Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease (Strong Hearts App)
- Conditions
- Congenital Heart Disease
- Interventions
- Behavioral: Strong Hearts Exercise Program
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
-
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
- 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
- Arm && Interventions
Group Intervention Description Exercise Group Strong Hearts Exercise Program 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.
- 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 sit-to-stand test Baseline, up to 12 weeks 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
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States