The Effect of Aerobic and Resistant Exercise Training on Hepatic Functions, Inflammatory Markers and Functional Capacity in Patients With Non-Alcoholic Steatohepatitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change from baseline hepatic steatosis percentage
研究概览
简要总结
The term non-alcoholic fatty liver disease (NAFLD) is used to describe a range of chronic liver diseases that range from steatosis to steatohepatitis, advanced fibrosis, cirrhosis, or excessive alcohol consumption or other causes of steatosis. In this spectrum, Non-Alcoholic Steatohepatitis (NASH), which defines liver damage accompanied by steatosis and inflammation (hepatitis), is one of the most common causes of chronic liver disease worldwide, especially in developed and developing countries, and is present in 15-35% of the general population. Individuals diagnosed with NASH primarily experience deterioration in liver functions, but patients are also affected in terms of vascular structures, immunopathological responses, functional and psychosocial conditions. It is seen that in addition to intrahepatic lipid content, inflammatory markers, liver enzymes, and liver functions, cardiopulmonary endurance, physical activity level, and muscle strength are also affected in these patients, so it is evaluated for the diagnosis and planning of the treatment of the disease. There is no drug with proven efficacy in the treatment of the disease. Since a significant proportion of NASH patients have obesity, Type II Diabetes Mellitus or dyslipidemia, the focus of treatment is to control risk factors or protect the liver from harmful factors such as TNFα. Therefore, the mainstay of treatment, for now, seems to be weight control with a lifestyle change, including regular exercise training and diet control. Exercise intervention is considered an essential component of NAFLD treatment, however; there are a limited number of published articles showing the effects of exercise training in the management of NASH. In addition, the physiological effect of exercise has still not been clarified because NASH is accompanied by metabolic problems such as obesity and T2DM. This study, it is aimed to bring innovation to the literature in understanding the physiological effects of exercise for this disease group by examining the effects of resistance exercise training in addition to aerobic exercise on intrahepatic lipid content, liver functions, inflammatory markers, muscle strength, functionality, and biopsychosocial status in individuals with NASH diagnosis who do not have an additional metabolic problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with NASH according to the diagnostic criteria determined by the American Gastroenterology Society / Asia-Pacific Working Group,
- •No history of hepatic decompensation such as hepatic encephalopathy or abdominal ascites,
- •Not being obese according to the criteria of the World Health Organization (Body Mass Index (BMI) <30),
- •HbA1c value <6.5%,
- •No changes in blood pressure, hyperlipidemia drugs in the last 3 months,
- •Absence of any mental disorder or exercise compliance problem that would prevent them from participating in the study.
- •It was determined as being voluntary to participate in the study.
排除标准
- •A history of liver disease other than NASH, such as acute or chronic viral hepatitis, autoimmune hepatitis,
- •Alcohol consumption >30 g/day in men and >20 g/day in women,
- •Having regular exercise habits,
- •Presence of conditions where exercise is contraindicated, such as unstable ischemia, decompensated heart failure, arrhythmia that increases with exercise and cannot be controlled, severe aortic stenosis, hypertrophic cardiomyopathy,
- •Having orthopedic problems that limit lower extremity movements such as previous cerebrovascular disease, neurological diseases that cause cognitive and motor loss such as Alzheimer's and Parkinson's, and endoprosthesis surgery in the last three months, permanent joint contracture,
- •Regular use of food supplements,
- •It was determined that he did not volunteer to participate in the study.
结局指标
主要结局
Change from baseline hepatic steatosis percentage
时间窗: Change from baseline steatosis percentage to 16th week
Magnetic Resonance Elastography (MRE) is a technology that combines MRI imaging with low-frequency vibrations to create a visual map (elastogram) that shows the stiffness of body tissues. Currently, MRE is used to detect stiffening of the liver caused by fibrosis and inflammation in chronic liver disease. In chronic liver disease, before reaching the stage of cirrhosis, while detecting fibrosis in the early stages, a tissue stiffness map called elastogram can be drawn. Because the waves can be visualized and analyzed deep in the liver, MRE can evaluate much larger amounts of the total liver than a liver biopsy and has been shown to have high diagnostic accuracy in studies.
Change from baseline intrahepatic lipid percentage
时间窗: Change from baseline intrahepatic lipid percentage to 16th week
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver, developed in order to facilitate, by enriching, patient recruitment for clinical trials in NASH. The PDFF method is the most objective method for lipid measurement in the liver.
Change of liver function parameters level
时间窗: Change from baseline liver function parameters level to 16th week
Routine liver function test results including alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin, and bilirubin will be measured. All parameters will be recorded in IU/L.The ALT and AST tests measure enzymes that the liver releases in response to damage or disease. The albumin test measures how well the liver creates albumin, while the bilirubin test measures how well it disposes of bilirubin. ALP can be used to evaluate the bile duct system of the liver.
Change of lipid panel
时间窗: Change from baseline lipid panel values to 16th week
The lipid panel analysis contains total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides. All parameters will be recorded in mg/dL. Higher than normal cholesterol levels are associated with cardiovascular and metabolic diseases. Also, high total cholesterol LDL or triglyceride ratios are associated with NASH. Therefore, the lipid profile is evaluated to monitor NASH progression.
次要结局
- Evaluation of inflammatory markers(5 minutes, through study completion, an average of 16 weeks, change from baseline inflammatory marker status at 16 weeks.)
- Evaluation of body mass index (BMI)(5 minutes, through study completion, an average of 16 weeks, change from baseline body mass index at 16 weeks)
- Daily calorie follow-up(5 minutes, through study completion, an average of 16 weeks, change from baseline daily diet statusat 16 weeks)
- Evaluation of physical activity level(5 minutes, through study completion, an average of 16 weeks, change from baseline physical activity level at 16 weeks.)
- Evaluation of aerobic capacity(12 minutes, through study completion, an average of 16 weeks, change from baseline aerobic capacity at 16 weeks.)
- Evaluation of muscle strength(10 minutes, through study completion, an average of 16 weeks, change from baseline fatique status at 16 weeks)
- Evaluation of pain(5 minutes, through study completion, an average of 16 weeks, change from baseline pain status at 16 weeks)
- Evaluation of fatigue(5 minutes, through study completion, an average of 16 weeks, change from baseline fatique status at 16 weeks)
- Evaluation of anxiety and depression(7 minutes, through study completion, an average of 16 weeks, change from baseline anxiety and depression status at 16 weeks)
- Evaluation of dynamic balance(5 minutes, through study completion, an average of 16 weeks, change from baseline dynamic balance at 16 weeks)
- Evaluation of quality of life(10 minutes, through study completion, an average of 16 weeks, change from baseline quality of life at 16 weeks)
- Evaluation of body fat percentage(5 minutes, through study completion, an average of 16 weeks, change from baseline body fat percentage at 16 weeks)
研究者
Fatma Birgul Kumbaroglu
Research Assistant, Physiotherapist
Hacettepe University