The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

This study has been completed.
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01264198
First received: July 6, 2010
Last updated: March 26, 2014
Last verified: December 2010

July 6, 2010
March 26, 2014
December 2010
September 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01264198 on ClinicalTrials.gov Archive Site
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The Role of Resistance Training in Non Alcoholic Fatty Liver Disease
The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • NAFLD (Non-Alcoholic Fatty Liver Disease)
  • Resistance Training
Behavioral: Resistance Training
Supervised Resistance Training
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
October 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01264198
TASMC-10-RO-330-CTIL
No
Prof. Ran Oren, Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Ran Oren, MD Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
December 2010

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