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
About this trial
This is an interventional treatment trial for NAFLD focused on measuring Diet, Physical Activity, NAFLD
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
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
NCT ID
NCT02367742
First Posted
February 13, 2015
Last Updated
March 23, 2015
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
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
We'll reach out to this number within 24 hrs