Clinical trial NCT05065593: The Effect of Aerobic and Resistant Exercise Training in Patients With Non-Alcoholic Steatohepatitis
Official title: The Effect of Aerobic and Resistant Exercise Training on Hepatic Functions, Inflammatory Markers and Functional Capacity in Patients With Non-Alcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-Alcoholic Steatohepatitis
Keywords: fibrosis
exercise
inflammation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline intrahepatic lipid percentage
timeFrame: Change from baseline intrahepatic lipid percentage to 16th week
measure: Change from baseline hepatic steatosis percentage
timeFrame: Change from baseline steatosis percentage to 16th week
measure: Change of liver function parameters level
timeFrame: Change from baseline liver function parameters level to 16th week
measure: Change of lipid panel
timeFrame: Change from baseline lipid panel values to 16th week
Secondary outcomes:
measure: Evaluation of inflammatory markers
timeFrame: 5 minutes, through study completion, an average of 16 weeks, change from baseline inflammatory marker status at 16 weeks.
measure: Evaluation of aerobic capacity
timeFrame: 12 minutes, through study completion, an average of 16 weeks, change from baseline aerobic capacity at 16 weeks.
measure: Evaluation of physical activity level
timeFrame: 5 minutes, through study completion, an average of 16 weeks, change from baseline physical activity level at 16 weeks.
measure: Evaluation of muscle strength
timeFrame: 10 minutes, through study completion, an average of 16 weeks, change from baseline fatique status at 16 weeks
measure: Evaluation of fatigue
timeFrame: 5 minutes, through study completion, an average of 16 weeks, change from baseline fatique status at 16 weeks
measure: Evaluation of pain
timeFrame: 5 minutes, through study completion, an average of 16 weeks, change from baseline pain status at 16 weeks
measure: Evaluation of quality of life
timeFrame: 10 minutes, through study completion, an average of 16 weeks, change from baseline quality of life at 16 weeks
measure: Evaluation of anxiety and depression
timeFrame: 7 minutes, through study completion, an average of 16 weeks, change from baseline anxiety and depression status at 16 weeks
measure: Evaluation of dynamic balance
timeFrame: 5 minutes, through study completion, an average of 16 weeks, change from baseline dynamic balance at 16 weeks
measure: Evaluation of body mass index (BMI)
timeFrame: 5 minutes, through study completion, an average of 16 weeks, change from baseline body mass index at 16 weeks
measure: Evaluation of body fat percentage
timeFrame: 5 minutes, through study completion, an average of 16 weeks, change from baseline body fat percentage at 16 weeks
measure: Daily calorie follow-up
timeFrame: 5 minutes, through study completion, an average of 16 weeks, change from baseline daily diet statusat 16 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Study officials:
References: