NCT04835831: STEATO-APA

Interest of APA in Fatty Liver Disease Evaluation of Efficacy and Adherence to an Adapted Physical Activity (APA) Program in Patients With Metabolic Fatty Liver Disease

Active, enrolled NA Last updated 3 December 2025

What this trial tests

NA trial testing adapted physical activity + Dietetic advice in Non-Alcoholic Fatty Liver Disease (NAFLD in 115 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 September 2021

Primary endpoint
15 June 2022

9 January 2026

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	115
Start date	15 September 2021
Primary completion	15 June 2022
Estimated completion	9 January 2026
Sites	2 locations across France

Drugs / interventions tested

• adapted physical activity + Dietetic advice

Conditions studied

• Non-Alcoholic Fatty Liver Disease (NAFLD — all drugs for Non-Alcoholic Fatty Liver Disease (NAFLD →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

Adults 18 to 90, any sex, with Non-Alcoholic Fatty Liver Disease (NAFLD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Non-Alcoholic Fatty liver Disease (NAFLD) is a Public Health problem. NAFLD affects nearly 25% of the world's population. NAFLD includes hepatic complications related to insulin resistance and metabolic inflammation. NAFLD is in fact a continuum of liver abnormalities that progresses from pure steatosis, to Non-Alcoholic Steato-Hepatitis-NASH, then to hepatic fibrosis, cirrhosis and even the appearance of primary liver cancer (hepatocellular carcinoma). Although many drugs are being tested for advanced forms of NAFLD, steatohepatitis (NASH) with fibrosis and post-NAFLD cirrhosis, there are currently no drugs with marketing authorization. Excessive and unbalanced dietary intake, excessive physical inactivity and lack of regular physical activity are major contributors to the development of NAFLD. It is therefore logical that the preventive and curative treatment of NAFLD is based on hygienic and dietary measures. Physical exercise alone in patients with NAFLD has been shown to improve liver steatosis even in the absence of weight loss. Proof of concept of the improvement in hepatic steatosis has been shown to be achieved by physical activity, whether or not associated with dietary management. More recently, APA (Adapted Physical Activity) is thus seen as a new modality of care that will become central to the prevention and treatment of NAFLD. The aim of this work is to evaluate the decrease in hepatic steatosis by continuous CAP® and parameters evaluating non-invasive inflammation and hepatic fibrosis in patients with NAFLD subjected to the application of personalized dietary measures without or with the performance of personalized and reproducible physical activity via the prescription of adapted physical activity. The evaluation will be carried out initially, at the end of the operation and 6 months after the end of the operation in order to look for a persistent effect of the modification in lifestyle.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. NAFLD and NAFLD Related HCC: Emerging Treatments and Clinical Trials.
   Khare T, Liu K, Chilambe LO, Khare S. · · 2025 · cited 12× · PMID 39796162 · DOI 10.3390/ijms26010306