Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition Intervention
NAFLD (Non-Alcoholic Fatty Liver Disease)
Resistance Training
Behavioral: Resistance Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 82
Study Start Date: December 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264198

Locations
Israel
Tel Aviv Sourasky Medical center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Ran Oren, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Prof. Ran Oren, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01264198     History of Changes
Other Study ID Numbers: TASMC-10-RO-330-CTIL
Study First Received: July 6, 2010
Last Updated: March 26, 2014
Health Authority: Israel: National Institute of Health

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on November 19, 2014