Effect of Physical Activity on NAFLD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Two Different Programs of Physical Activity on the Grade of Severity of NAFLD

Conditions
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NAFLD

Intervention / Treatment
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* Behavioral: Endurance Activity (EA)
* Behavioral: EA + Resistance Training (RT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate or severe NAFLD Enrolled in the previous trial called NUTRIEP Exclusion Criteria: Not enrolled in the previous trial called NUTRIEP

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endurance Activity (EA)<br>The subjects have followed a program of endurance (aerobic) activity (EA). | Behavioral: Endurance Activity (EA)<br>* 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%.<br>|
| Other: EA + Resistance Training (RT)<br>The subjects have followed a program of endurance activity (EA) and resistance training (RT). | Behavioral: EA + Resistance Training (RT)<br>* 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%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in NAFLD score at three and six months |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Indirect calorimetry at three and six months |  | Six months | 
| Percentage Change from Baseline in Bioimpedenziometry at three and six months | Percentage reduction in Fat Mass; Percentage increase in Muscle mass | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Physical Activity, NAFLD