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App-Based exercise program aims to strengthen hearts in congenital disease

NCT ID NCT05853705

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study tests a remote, app-enabled exercise program designed for people aged 10 to 50 with congenital heart disease. Participants use a smartphone app with exercise modules and wearable devices to track heart rate and progress. The goal is to see if this approach can safely improve fitness, measured by changes in peak oxygen uptake, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Strong Hearts Exercise Program (a remote, app-enabled exercise program with wearable integration)
What this could lead to
If successful, this could provide a safe, accessible way for people with congenital heart disease to improve their fitness and quality of life from home.
What could go wrong
This is a small pilot study, so results may not apply to everyone. The program's effectiveness and safety in a broader population remain uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital heart disease

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.