The Role of Resistance Training in Non Alcoholic Fatty Liver Disease
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (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 |
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| Contact: Ran Oren, MD | 972-3-6973984 | roren@tasmc.health.gov.il |
| Israel | |
| Tel Aviv Sourasky Medical center | Not yet recruiting |
| Tel Aviv, Israel, 64239 | |
| Principal Investigator: Ran Oren, MD | |
| 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: | December 20, 2010 |
| Health Authority: | Israel: National Institute of Health |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013