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

NCT04835831 | Active Not Recruiting

• 1 other identifier: 20-AOI-04
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD

Outcome Measures

Primary Outcomes (2)

• Continuous CAP decreased by 10%

  evaluate the decrease in hepatic steatosis by continuous CAP®

  evaluated at day 0

• Continuous CAP decreased by 10%

  evaluate the decrease in hepatic steatosis by continuous CAP®

  evaluated after the 12 weeks

Secondary Outcomes (9)

• Anthropometric parameters

  evaluated at day 0

• Anthropometric parameters

  evaluated after the 12 weeks

• Muscular performance

  evaluated at day 0

• Muscular performance

  evaluated after the 12 weeks

• Muscular performance

  evaluated after the 24 weeks

Study Arms (2)

adapted physical activity + Dietetic advice

EXPERIMENTAL

Other: adapted physical activity + Dietetic advice

Dietetic advice only

NO INTERVENTION

Interventions

adapted physical activity + Dietetic advice OTHER

adapted physical activity during 24 weeks

adapted physical activity + Dietetic advice

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de Nice

Nice, France, 06000, France

Location

Ch de Perpignan

Perpignan, France, 66046, France

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Rodolphe ANTY

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: September 15, 2021
• Primary Completion: June 15, 2022
• Study Completion: January 9, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)