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Terminated

NCT Number: NCT05853705

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

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.

Why the study stopped: Low participation rate
Terminated

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

10 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline, up to 12 weeks

Secondary outcomes

  1. Change in Pediatric Cardiac Quality of Life Inventory

    Time frame: 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.

  2. Change in Short Form 36 (SF-36) Health Survey

    Time frame: 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.

  3. Change in sit-to-stand test

    Time frame: Baseline, up to 12 weeks

  4. Change in secondary Cardiopulmonary Exercise Testing outcome measures

    Time frame: Baseline, up to 12 weeks

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 11, 2023
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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