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Effect of Physical Activity on NAFLD

Primary Purpose

NAFLD

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endurance Activity (EA)
EA + Resistance Training (RT)
Sponsored by
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD focused on measuring Diet, Physical Activity, NAFLD

Eligibility Criteria

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

Inclusion Criteria:

  • Moderate or severe NAFLD
  • Enrolled in the previous trial called NUTRIEP

Exclusion Criteria:

  • Not enrolled in the previous trial called NUTRIEP

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Endurance Activity (EA)

    EA + Resistance Training (RT)

    Arm Description

    The subjects have followed a program of endurance (aerobic) activity (EA).

    The subjects have followed a program of endurance activity (EA) and resistance training (RT).

    Outcomes

    Primary Outcome Measures

    Change from Baseline in NAFLD score at three and six months

    Secondary Outcome Measures

    Change from Baseline in Indirect calorimetry at three and six months
    Percentage Change from Baseline in Bioimpedenziometry at three and six months
    Percentage reduction in Fat Mass; Percentage increase in Muscle mass

    Full Information

    First Posted
    February 13, 2015
    Last Updated
    March 23, 2015
    Sponsor
    Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02367742
    Brief Title
    Effect of Physical Activity on NAFLD
    Official Title
    Effect of Two Different Programs of Physical Activity on the Grade of Severity of NAFLD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    It has been demonstrated the essential role of physical activity in the prevention of overweight and obesity. Nevertheless, the effect of a program of physical activity on the maintenance of body weight in subjects who have previously followed a dietary intervention is still unknown. The aim of this study was to investigate this topic by evaluating the effect of two different programs of physical activity on subjects who have followed a dietary intervention but presented again NAFLD a year after the treatment.
    Detailed Description
    Subjects who were previously enrolled in the trial NUTRIEP and who still have NAFLD a year after the end of the study, were invited to participate in a program of physical activity to assess the effect of endurance and resistance training on weight and NAFLD score. Participants (100 subjects) were randomized and divided into two groups: the first followed a program of endurance activity consisting in a 30 minute walk, 5 times/week; the second followed a program combining the just described aerobic exercise with a resistance training based on 30 minute of musculation involving all the bigger muscles, 3 times/week. The trial lasted six months and subjects underwent liver ultrasonography (to assess NAFLD score), indirect calorimetry, bioimpedenziometry, the measurement of anthropometric variables (body height and weight) and biological parameters (glucose, insulin, cholesterol, HDL cholesterol, triglycerides, GOT, GPT and GGT) at the baseline and at the third and the sixth month. The aim of the study was to estimate the effect of the two different programs of physical activity on NAFLD score. Secondary end-points included: the effect on basal metabolism, the modification of fat mass (FM), lean mass (LM) and muscle mass (MM) and on several biological markers associated with NAFLD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NAFLD
    Keywords
    Diet, Physical Activity, NAFLD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Endurance Activity (EA)
    Arm Type
    Other
    Arm Description
    The subjects have followed a program of endurance (aerobic) activity (EA).
    Arm Title
    EA + Resistance Training (RT)
    Arm Type
    Other
    Arm Description
    The subjects have followed a program of endurance activity (EA) and resistance training (RT).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Endurance Activity (EA)
    Intervention Description
    Subjects have followed a program of endurance activity consisting in a 30 minute walk, 5 times/week. Exercise intensity started from the 60% of the maximum heart rate and raised up to the 75%.
    Intervention Type
    Behavioral
    Intervention Name(s)
    EA + Resistance Training (RT)
    Intervention Description
    Subjects have followed a program combining endurance activity (EA) and resistance training (RT) consisting in a 60 minute work session, 3 times/week consisting in: Walk (30 minutes): exercise intensity started from the 60% of the maximum heart rate and raised up to the 75%. Musculation (30 minutes): training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutei and legs). Exercise intensity started from the 65% of the maximum rated load and raised up to the 75%.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in NAFLD score at three and six months
    Time Frame
    Six months
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in Indirect calorimetry at three and six months
    Time Frame
    Six months
    Title
    Percentage Change from Baseline in Bioimpedenziometry at three and six months
    Description
    Percentage reduction in Fat Mass; Percentage increase in Muscle mass
    Time Frame
    Six months
    Other Pre-specified Outcome Measures:
    Title
    Height
    Time Frame
    At baseline
    Title
    Change from Baseline in Body Weight at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Systolic blood pressure at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Diastolic blood pressure at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Serum Fasting Glucose at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Serum GOT at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Serum GPT at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Serum gamma-GT at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Serum Cholesterol at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Serum HDL Cholesterol at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Serum Triglycerides at three and six months
    Time Frame
    Six months
    Title
    Change from Baseline in Serum Insulin at three and six months Insulin
    Time Frame
    Six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Moderate or severe NAFLD Enrolled in the previous trial called NUTRIEP Exclusion Criteria: Not enrolled in the previous trial called NUTRIEP
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alberto R Osella, MD, PhD
    Organizational Affiliation
    IRRCS "Saverio De Bellis", Via Turi 27, 70013, Castellana Grotte (Bari), Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Physical Activity on NAFLD

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