Back to resultsThe Role of Resistance Training in Non Alcoholic Fatty Liver Disease
Primary Purpose
NAFLD (Non-Alcoholic Fatty Liver Disease), Resistance Training
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Resistance Training
Sponsored by
About this trial
This is an interventional treatment trial for NAFLD (Non-Alcoholic Fatty Liver Disease)
Eligibility 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.
Sites / Locations
- Tel Aviv Sourasky Medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Stretching Exercises
Resistance Training
Arm Description
The patients will perform twice weekly home based static stretching workout.
The patients will perform twice weekly supervised RT for 3 months
Outcomes
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01264198
First Posted
July 6, 2010
Last Updated
March 26, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01264198
Brief Title
The Role of Resistance Training in Non Alcoholic Fatty Liver Disease
Official Title
The Role of Resistance Training in Non Alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD (Non-Alcoholic Fatty Liver Disease), Resistance Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stretching Exercises
Arm Type
Sham Comparator
Arm Description
The patients will perform twice weekly home based static stretching workout.
Arm Title
Resistance Training
Arm Type
Experimental
Arm Description
The patients will perform twice weekly supervised RT for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training
Intervention Description
Supervised Resistance Training
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Oren, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
27863097
Citation
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.
Results Reference
derived
Learn more about this trial
The Role of Resistance Training in Non Alcoholic Fatty Liver Disease
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