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Exercise over pills: new study tests if moving more can shrink fatty liver

NCT ID NCT04835831

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study is testing whether a 24-week program of adapted physical activity, combined with diet advice, can reduce liver fat in 115 adults with non-alcoholic fatty liver disease (NAFLD). Participants will follow personalized exercise and diet plans, and researchers will measure changes in liver fat, weight, and muscle function. The goal is to see if lifestyle changes alone can help control this common liver condition.

What this could mean

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

Active substance
adapted physical activity program plus dietetic advice
What this could lead to
If successful, this could show that a structured exercise program helps reduce liver fat in people with fatty liver disease, offering a drug-free management option.
What could go wrong
This is a small pilot study with no control group, so results may not be definitive. Long-term adherence and lasting effects 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.

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

115 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Jan 2026

An estimate. End dates often move.

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

18 to 90 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: * Patient aged 18 and over * Affiliated with social security * Signature of informed consent * Diagnosis of NAFLD characterized by the presence of ultrasound steatosis, with a diagnosis made by a physician after a clinical and paraclinical examination as is usually done in routine care and having eliminated another cause of chronic liver disease. * Effective contraception system for women of childbearing age, a urine pregnancy test will be offered to these women as part of the assessment of the screening visit. Exclusion Criteria: * Patient under legal protection * Refusal to participate in the study * Alcohol consumption ≥ 30 g/d for men or ≥ 20 g/d for women * Presence of chronic liver disease from causes other than NAFLDs * Inability to obtain 10 valid measurements when performing a FibroScan liver elasticity measurement or continuous CAP® steatosis assessment during initial evaluation. * FibroScan ≥ 20 kPa at initial assessment * Presence or history of advanced chronic liver disease (cirrhosis) decompensated (Child A6, B or C). * Known history of a complication related to portal hypertension (including digestive haemorrhage related to portal hypertension, ascites or pleural effusion of cirrhotic cirrhosis, port-pulmonary hypertension). * Notion of type 2 diabetes unbalanced with an HbA1c ≥ 9%, less than 3 months (measurement of HbA1c is not required before signing the consent form). * Platelets \< 150000/mm3, within the previous 6 months. * Type 1 diabetes * Weight loss ≥ 10% of usual body weight, in the 6 months prior to inclusion * Introduction or dose modification of a GLP1 or orlistat agonist treatment \< 1 year * Practice of regular and/or intense physical activity, weekly (more than 3 hours per week) * Patients with solid organ or bone marrow transplants * Patient participating in another study evaluating a therapy to improve non-alcoholic fatty liver disease (NAFLD) * Contraindication to carrying out APA: * Absolute contraindication criteria: Any unstable pathology affecting a vital organ in particular cardiovascular or pulmonary. Unstable means any situation in which the absence of urgent therapeutic intervention could lead to the death of the patient. o Contraindication to physical activity Unstable acute coronary syndrome Decompensated heart failure Severe, uncontrolled ventricular rhythm disturbances Presence of an intracardiac thrombus with high embolic risk Presence of a medium to large pericardial effusion Recent history (\<6 months) of thrombophlebitis with or without pulmonary embolism Severe and/or symptomatic left ventricular ejection obstruction Any progressive inflammatory and/or infectious disease Severe pulmonary arterial hypertension

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CHU de Nice

    Nice, France, 06000, France

  • Ch de Perpignan

    Perpignan, France, 66046, France

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