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NCT01264198 Clinical Trial

The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

Resistance Training Clinical Trial

Official title:
The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01264198
Other study ID # TASMC-10-RO-330-CTIL
Secondary ID
Status Completed
Phase N/A
First received July 6, 2010
Last updated March 26, 2014
Start date December 2010
Est. completion date October 2012

Study information
Verified date December 2010
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: National Institute of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Resistance Training
Supervised Resistance Training

Locations
Country Name City State
Israel Tel Aviv Sourasky Medical center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). week 0 and week 13 No
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