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Leg strength may be key to heart health in rare condition

NCT ID NCT07420660

Knowledge-focused Sponsor: Karolinska Institutet 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study looks at how leg muscle size and strength affect circulation in people born with a single-chamber heart, a condition where the heart can't pump blood to the lungs on its own. Researchers will measure muscle mass, oxygen use, and quality of life in 40 adults aged 16-50 who have had the Fontan procedure. The goal is to understand the link between muscles and circulation, which could lead to better exercise programs for these patients.

What this could mean

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

What this could lead to
If successful, this research could lead to better exercise recommendations and muscle-strengthening programs to improve circulation and quality of life for people with single-chamber hearts.
What could go wrong
This is an observational study with only 40 participants, so results may not apply to everyone. It aims to understand the problem, not test a treatment, so direct benefits are 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.

Participants

34 people

The number who actually took part.

Started

Feb 2026

Finished

Jun 2026

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.

Who is studied

Patients linked to the Region Stockholm outpatient clinic

Ages

16 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: * Diagnosis of a Fontan circulation: individuals who have undergone the Fontan procedure with only one functioning systemic ventricle, confirmed by medical records or attending physician. * Stable clinical status: patients should be clinically stable without significant cardiovascular or renal dysfunction as determined by clinical examinations. * Age range: 16-50 years. * Ability to exercise: Participants must be physically able to participate in the exercise protocol according to a preliminary medical examination. Controls: Age and sex-matched. Healthy (no chronic diseases, assessed by health questionnaire and interview). Exclusion Criteria: * Recent surgery or hospitalization: individuals who have undergone cardiovascular surgery or hospitalization within six months prior to inclusion. * Severe functional limitations: Patients with clear functional limitations unrelated to Fontan physiology, such as musculoskeletal disorders. * Significant comorbidities: Serious non-cardiac comorbidities that may independently affect work capacity, such as advanced pulmonary disease. * Contraindications for exercise testing: Conditions that contraindicate physical testing, such as uncontrolled cardiac arrhythmias or severe heart failure (New York Heart Association III-IV).

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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.

Fontan circulation

Contacts and locations

Locations

  • Karolinska University Hospital

    Stockholm, Sweden

More trials for these conditions

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