None listed
Conditions
Brief summary
STUDY DESIGN: This study will use a single group design to examine the effects of an exercise intervention on patient outcomes with pre and post assessment. The aim of the study is to improve the hepatic and cardio-metabolic profile of these patients. OUTCOME MEASURES: After referral and screening by the treating specialist participants will undergo baseline assessment. Outcomes will include: - Hepatic steatosis - Plasma lipid profile, insulin, glucose, HOMA2, markers of liver damage (ALT, CK18) and liver enzymes - Arterial stiffness (measured non-invasively via PWA/PWV) - Body composition (DEXA / MRI) - Cardiorespiratory fitness - Muscular strength and physical function EXERCISE INTERVENTION: Participants will undertake supervised training 3 days per week consisting of a combination of aerobic and resistance training. training load and volumes will be individualized based on pre assessment results and progressed throughout the study. SIGNIFICANCE: This study will establish the feasibility and efficacy of an exercise intervention on this patient population and will help inform the design of future larger multi-centre studies of exercise as an adjuvant therapy in advanced liver disease.
Interventions
The study will use a 3 month (12 week) supervised exercise program.
The program will consist of 3 sessions per week (Monday, Wednesday, Friday) and each session will be 60 minutes in duration.
The exercises sessions will include a suitable warm up before moving on to a combination of aerobic and resistance exercises.
Aerobic exercise will be either bicycle or treadmill based and the workload and intensity (% of heart rate maximum) based on the results of pre testing.
Resistance exercises will b
The study will use a 3 month (12 week) supervised exercise program. The program will consist of 3 sessions per week (Monday, Wednesday, Friday) and each session will be 60 minutes in duration. The exercises sessions will include a suitable warm up before moving on to a combination of aerobic and resistance exercises. Aerobic exercise will be either bicycle or treadmill based and the workload and intensity (% of heart rate maximum) based on the results of pre testing. Resistance exercises will be primarily machine based, targeting major muscle groups for the upper and lower body. Exercises will include, but may not be limited to, seated leg press, seated leg curl and extension, calf raises, seated chest press, latissimus pull down, bicep curl and tricep extension. Weights used will be based on a percentage of the load lifted at baseline testing and be progressed in small increments each week. Each exercise session will be supervised by an experienced exercise physiologist accredited with Exercise and Sports Science Australia.
Sponsors
School of medicine and pharmacology, University of Western Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
Outcome results
None listed