The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT01264198

First received: July 6, 2010

Last updated: December 20, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 6, 2010

Last Updated Date

December 20, 2010

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01264198 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

Official Title ^ICMJE

The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

Brief Summary

The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in patients with NAFLD.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

NAFLD (Non-Alcoholic Fatty Liver Disease)
Resistance Training

Intervention ^ICMJE

Behavioral: Resistance Training

Supervised Resistance Training

Study Arm (s)

Sham Comparator: Stretching Exercises
The patients will perform twice weekly home based static stretching workout.

Intervention: Behavioral: Resistance Training
Experimental: Resistance Training
The patients will perform twice weekly supervised RT for 3 months

Intervention: Behavioral: Resistance Training

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2012

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ran Oren, MD

972-3-6973984

roren@tasmc.health.gov.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01264198

Other Study ID Numbers ^ICMJE

TASMC-10-RO-330-CTIL

Has Data Monitoring Committee

Responsible Party

Prof. Ran Oren, Tel-Aviv Sourasky Medical Center

Study Sponsor ^ICMJE

Tel-Aviv Sourasky Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ran Oren, MD

Tel-Aviv Sourasky Medical Center

Information Provided By

Tel-Aviv Sourasky Medical Center

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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