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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853705
• Other study ID #: Pro00111958
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2024
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Stefany Olague, MPH
• Phone: 9196688131
• Email: smalltrials-CRC[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak rate of oxygen volume consumption (VO2) on Cardiopulmonary Exercise Testing		Baseline, up to 12 weeks
Secondary	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
Secondary	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
Secondary	Change in sit-to-stand test		Baseline, up to 12 weeks
Secondary	Change in secondary Cardiopulmonary Exercise Testing outcome measures		Baseline, up to 12 weeks