Feasibility and efficacy of a 3 month progressive exercise program in patients with non-alcoholic steatohepatitis (NASH) related cirrhosis

Not Applicable

Recruiting

• Conditions: non-alcoholic steatohepatitis (NASH); Liver cirrhosis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12613000771752
• Lead Sponsor: School of medicine and pharmacology, University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Liver cirrhosis due to nonalcoholic steatohepatitis

Exclusion Criteria

Inability to provide informed consent
Inability to speak english
Other causes of liver disease as determined by hepatitis B and C serology, auto-antibodies (anti-nuclear, anti-smooth muscle, anti-mitochondrial), alpha-one anti-trypsin level and ceruloplasmin
Hereditary hemochromatosis (C282Y/C282Y or C282Y/H63D HFE gene mutation)
Alcohol consumption greater than 20 grams/day for males, greater than 10 grams/day for females
Secondary causes for NAFLD (corticosteroids, gastro-intestinal bypass
Use of anti-oxidants (vitamin E or C) or anti-TNF agents (pentoxifylline)
Poor glycaemic control (HbA1c greater than 8.5%)
Any musculoskeletal, cardiovascular or neurological conditions that will prevent them form being able to complete a 400m walk or participate in resistance training

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in cardiorespiratory fitness as determined by changes in oxygen uptake (VO2). <br>Measured by graded cycle ergometry test and cardiopulmonary assessment[End of 12 week exercise program]

Secondary Outcome Measures

Name	Time	Method
Improvement in muscular strength as determined by 1 repitition strength tests[End of 12 week exercise program];Serum mediators of inflammation and metabolism (Adiponectin, IL-6, free fatty acids, TNF,C-RP).<br> [End of 12 week exercise program ];Serum markers of liver damage (ALT, CK-18)[End of 12 week exercise program];Hepatic steatosis as determined by magnetic resonance spectroscopy[End of 12 week exercise program];Arterial stiffness (measured non-invasively via sphygmocor)[End of 12 week exercise program];Quality of life measures.<br>Determined via self reported questionaries [End of 12 week exercise program]