The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

March 26, 2014 updated by: Tel-Aviv Sourasky Medical Center
The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in patients with NAFLD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Non Alcoholic Fatty Liver Disease (NAFLD) is the most prevalent liver disease in developed countries with a prevalence rate of 20-30 % of adults. About 10-25% of these individuals are estimated to meet the current diagnostic criteria for Non Alcoholic Steatohepatitis (NASH) and some may progress to Cirrhosis and liver failure. NAFLD is now recognized as the hepatic manifestation of the metabolic syndrome. Recent data shows that NAFLD might also predict the tendency to develop diabetes mellitus and coronary artery disease. The drug of choice for NAFLD is yet to be found. The recommended treatment of NAFLD includes weight reduction and Physical Activity (PA), but the data of the effect of Resistance Training (RT) PA on NAFLD is scant.

Aim of the study: To evaluate the effect of RT on clinical and metabolic parameters in patients with NAFLD. Study design: Randomized Clinical Trial. Patients will be randomly allocated to 2 arms (intervention and control). The intervention arm will perform RT, whereas control arm will be advised to perform home stretching. Medical examination will be performed at week 0 (baseline) and at week 13 using uniform protocols.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ultrasound diagnosed fatty liver.

Exclusion Criteria:

  • Presence of HBsAg or anti-HCV antibodies (will be obtained from blood tests at the liver clinic).
  • Patients with known diabetes treated with antidiabetic medications.
  • Patients with known kidney disease, CHD, lung disease, inflammatory bowel disease.
  • Excessive alcohol consumption ≥ 30 g/day in men or 20 g/ day in women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Stretching Exercises
The patients will perform twice weekly home based static stretching workout.
Behavioral: Resistance Training
Supervised Resistance Training
EXPERIMENTAL: Resistance Training
The patients will perform twice weekly supervised RT for 3 months
Behavioral: Resistance Training
Supervised Resistance Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The HRI value will be reduced in the intervention arm as compared to the The The change in Hepato-Renal Index (HRI) evaluated by ultrasound (US).
Time Frame: week 0 and week 13
week 0 and week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Ran Oren, MD, Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (ESTIMATE)

December 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-10-RO-330-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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