The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

NCT ID: NCT01264198

Last Updated: 2014-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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NAFLD (Non-Alcoholic Fatty Liver Disease) Resistance Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stretching Exercises

The patients will perform twice weekly home based static stretching workout.

Group Type SHAM_COMPARATOR

Resistance Training

Intervention Type BEHAVIORAL

Supervised Resistance Training

Resistance Training

The patients will perform twice weekly supervised RT for 3 months

Group Type EXPERIMENTAL

Resistance Training

Intervention Type BEHAVIORAL

Supervised Resistance Training

Interventions

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Resistance Training

Supervised Resistance Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel-Aviv Sourasky Medical Center

Principal Investigators

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Ran Oren, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Tel Aviv Sourasky Medical center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 27863097 (View on PubMed)

Other Identifiers

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TASMC-10-RO-330-CTIL

Identifier Type: -

Identifier Source: org_study_id

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