Effect of Physical Activity on NAFLD

Not Applicable

Completed

• Conditions: NAFLD
• Interventions: Behavioral: Endurance Activity (EA); Behavioral: EA + Resistance Training (RT)

• Registration Number: NCT02367742
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2015-02
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Not enrolled in the previous trial called NUTRIEP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endurance Activity (EA)	Endurance Activity (EA)	The subjects have followed a program of endurance (aerobic) activity (EA).
EA + Resistance Training (RT)	EA + Resistance Training (RT)	The subjects have followed a program of endurance activity (EA) and resistance training (RT).

Primary Outcome Measures

Name	Time	Method
Change from Baseline in NAFLD score at three and six months	Six months

Secondary Outcome Measures

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