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App-Enabled Exercise Program for Congenital Heart Disease

N/A

Waitlist Available

Led By Reid C Chamberlain, MD, MSCI

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Repaired or unrepaired Congenital Heart Disease (CHD) between ages 10 and 50, inclusive, at time of consent

Be younger than 65 years old

Must not have

Physical or mental disabilities preventing exercise participation

Uncontrolled systemic hypertension (symptomatic or greater than Stage 2 hypertension while on therapy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will create an app-enabled exercise program for CHD patients with real-time data collection & safety monitoring, to be applied to other conditions in the future. #healthcare #telemedicine

Who is the study for?

This trial is for people aged 10-50 with Congenital Heart Disease (CHD), who have an Android (6.0+) or Apple smartphone (iOS 13+). It's not for pregnant individuals, those with disabilities that prevent exercise, uncontrolled high blood pressure, poorly managed arrhythmia, or unstable heart failure.

What is being tested?

The Strong Hearts Exercise Program is being tested to see if a mobile app can help patients with CHD exercise safely. The app includes exercise modules and uses wearable devices to track real-time data on compliance and safety.

What are the potential side effects?

Since this program involves physical activity tailored for CHD patients, potential side effects may include typical exercise-related issues such as muscle soreness or fatigue. However, the program aims to minimize risks by monitoring participants' health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have congenital heart disease and am between 10 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a disability that stops me from exercising.

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My high blood pressure is not controlled even with medication.

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I have a heart rhythm problem that is not well-controlled.

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My heart failure is not stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Pediatric Cardiac Quality of Life Inventory

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Exercise GroupExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met