Effect of Physical Activity on NAFLD

NCT ID: NCT02367742

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

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.

Conditions

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NAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Endurance Activity (EA)

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

Group Type OTHER

Endurance Activity (EA)

Intervention Type BEHAVIORAL

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%.

EA + Resistance Training (RT)

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

Group Type OTHER

EA + Resistance Training (RT)

Intervention Type BEHAVIORAL

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%.

Interventions

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Endurance Activity (EA)

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

EA + Resistance Training (RT)

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%.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role lead

Responsible Party

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Alberto R Osella

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto R Osella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRRCS "Saverio De Bellis", Via Turi 27, 70013, Castellana Grotte (Bari), Italy

Other Identifiers

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NUTRIEPATT

Identifier Type: -

Identifier Source: org_study_id

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