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Evaluation of the Efficacy and Adherence to an Adapted Physical Activity (APA) Program for Patients With NAFLD (APA-NAFLD)

Primary Purpose

Non-Alcoholic Fatty Liver Disease (NAFLD

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
adapted physical activity + Dietetic advice
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease (NAFLD

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    adapted physical activity + Dietetic advice

    Dietetic advice only

    Arm Description

    Outcomes

    Primary Outcome Measures

    Continuous CAP decreased by 10%
    evaluate the decrease in hepatic steatosis by continuous CAP®
    Continuous CAP decreased by 10%
    evaluate the decrease in hepatic steatosis by continuous CAP®

    Secondary Outcome Measures

    Anthropometric parameters
    assessment of weight
    Anthropometric parameters
    assessment of weight
    Muscular performance
    assement with 6-minute walk test
    Muscular performance
    assement with 6-minute walk test
    Muscular performance
    assement with 6-minute walk test
    Muscular performance
    assement with 6-minute walk test
    questionnaire: Short Form 36 Health Survey [SF36].
    assessment between 0 to 100
    questionnaire: Short Form 36 Health Survey [SF36].
    assessment between 0 to 100
    questionnaire: Short Form 36 Health Survey [SF36].
    assessment between 0 to 100

    Full Information

    First Posted
    April 6, 2021
    Last Updated
    April 6, 2021
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04835831
    Brief Title
    Evaluation of the Efficacy and Adherence to an Adapted Physical Activity (APA) Program for Patients With NAFLD
    Acronym
    APA-NAFLD
    Official Title
    Evaluation of the Efficacy and Adherence to an Adapted Physical Activity (APA) Program for Patients With NAFLD, a Randomized, Open-label, Bicentric Pilot Study (APA-NAFLD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2, 2021 (Anticipated)
    Primary Completion Date
    April 2, 2023 (Anticipated)
    Study Completion Date
    April 2, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    Non-Alcoholic Fatty Liver Disease (NAFLD) affects nearly 25% of the world's population and can lead to cirrhosis and hepatocellular carcinoma . Exercise alone in patients with NAFLD has been shown to improve hepatic steatosis. Since 2017, adapted physical activity (APA) has been a medical prescription by the referring physician in France. APA is thus expected to be a new treatment modality that will become central to the prevention and treatment of NAFLD. The reference examination for the non-invasive quantification of liver steatosis was the Spectro Magnetic Resonance Imaging (MRI) however this technique is expensive and until now reserved for research in highly specialized centers. More recently, the analysis of the MRI signal by a magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) sequence acquired during the performance of a classical MRI scan has been validated as a new, reliable technique that is easier to use routinely than Spectro MRI. However, different technical variants currently not standardized for the quantification of steatosis by PDFF MRI exist. MRI is not widely available and must be performed in a competent and expert center. In contrast, the quantification of steatosis by ultrasound using the classical "Controlled Attenuation Parameter" (CAP®) is available thanks to a FibroScan, which is widely distributed over France. Even if the quantification of steatosis is better by PDFF MRI than by the classical CAP®, the quantification of steatosis by the classical CAP® is well correlated with the hepatic histology. In addition, several studies have found a decrease in classical CAP® when applying non-drug or drug therapies to lose weight and/or improve insulin resistance in patients with NAFLD. Very recently, Echosens has developed a new technique -the continuous CAP- to improve the reliability of the classical CAP® in the evaluation of steatosis [Audiere et al. ILC 2020]. Continuous CAP® is no longer based on 10 but on 200 measurements of hepatic steatosis. This new measurement technique reduces the variability of the measurement of liver steatosis quantification by 42%. The aim of this work is to evaluate the decrease in hepatic steatosis by continuous CAP® and parameters evaluating non-invasively 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 an adapted physical activity. The evaluation will be carried out initially, at the end of the APA program and 24 weeks after the end of the APA program in order to look for a persistent effect of the modification in lifestyle.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Alcoholic Fatty Liver Disease (NAFLD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    105 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    adapted physical activity + Dietetic advice
    Arm Type
    Experimental
    Arm Title
    Dietetic advice only
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    adapted physical activity + Dietetic advice
    Intervention Description
    adapted physical activity during 24 weeks
    Primary Outcome Measure Information:
    Title
    Continuous CAP decreased by 10%
    Description
    evaluate the decrease in hepatic steatosis by continuous CAP®
    Time Frame
    evaluated at day 0
    Title
    Continuous CAP decreased by 10%
    Description
    evaluate the decrease in hepatic steatosis by continuous CAP®
    Time Frame
    evaluated after the 12 weeks
    Secondary Outcome Measure Information:
    Title
    Anthropometric parameters
    Description
    assessment of weight
    Time Frame
    evaluated at day 0
    Title
    Anthropometric parameters
    Description
    assessment of weight
    Time Frame
    evaluated after the 12 weeks
    Title
    Muscular performance
    Description
    assement with 6-minute walk test
    Time Frame
    evaluated at day 0
    Title
    Muscular performance
    Description
    assement with 6-minute walk test
    Time Frame
    evaluated after the 12 weeks
    Title
    Muscular performance
    Description
    assement with 6-minute walk test
    Time Frame
    evaluated after the 24 weeks
    Title
    Muscular performance
    Description
    assement with 6-minute walk test
    Time Frame
    evaluated after the 48 weeks
    Title
    questionnaire: Short Form 36 Health Survey [SF36].
    Description
    assessment between 0 to 100
    Time Frame
    evaluated at day 0
    Title
    questionnaire: Short Form 36 Health Survey [SF36].
    Description
    assessment between 0 to 100
    Time Frame
    evaluated after the 24 weeks
    Title
    questionnaire: Short Form 36 Health Survey [SF36].
    Description
    assessment between 0 to 100
    Time Frame
    evaluated after the 48 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MARION Causeret
    Phone
    0492034702
    Email
    causeret.m@chu-nice.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ANTY Rodolphe
    Organizational Affiliation
    Centre Hospitalier Universitaire de Nice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of the Efficacy and Adherence to an Adapted Physical Activity (APA) Program for Patients With NAFLD

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