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Clinical Trials/NCT02367742
NCT02367742
Completed
Not Applicable

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

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis0 sites100 target enrollmentJanuary 2013
ConditionsNAFLD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
NAFLD
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Enrollment
100
Primary Endpoint
Change from Baseline in NAFLD score at three and six months
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Responsible Party
Principal Investigator
Principal Investigator

Alberto R Osella

MD, PhD

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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

Outcomes

Primary Outcomes

Change from Baseline in NAFLD score at three and six months

Time Frame: Six months

Secondary Outcomes

  • 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)

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