The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

Tracking Information
First Submitted Date ICMJE	July 6, 2010
First Posted Date ICMJE	December 21, 2010
Last Update Posted Date	March 27, 2014
Study Start Date ICMJE	December 2010
Actual Primary Completion Date	September 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 20, 2010)	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 ]
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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	NAFLD (Non-Alcoholic Fatty Liver Disease); Resistance Training
Intervention ICMJE	Behavioral: Resistance Training; Supervised Resistance Training
Study Arms	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 *	Zelber-Sagi S, Azar S, Nemirovski A, Webb M, Halpern Z, Shibolet O, Tam J. Serum levels of endocannabinoids are independently associated with nonalcoholic fatty liver disease. Obesity (Silver Spring). 2017 Jan;25(1):94-101. doi: 10.1002/oby.21687. Epub 2016 Nov 15.
* 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	Completed
Actual Enrollment ICMJE; (submitted: March 26, 2014)	82
Original Estimated Enrollment ICMJE; (submitted: December 20, 2010)	80
Actual Study Completion Date	October 2012
Actual Primary Completion Date	September 2012 (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.
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years to 60 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Israel
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01264198
Other Study ID Numbers ICMJE	TASMC-10-RO-330-CTIL
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
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
PRS Account	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