The Effect of Aerobic and Resistant Exercise Training in Patients With Non-Alcoholic Steatohepatitis

NCT ID: NCT05065593

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2025-01-30

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.

Conditions

Non-Alcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Face-to-Face Training Group

After completing all assessments, the intervention group will participate in face-to-face exercise training with a physiotherapist for 3 days for 4 months.

In the first week, patients will be taught body awareness; parameters of correct loading on the muscle will be explained and the limits of safe exercise will be drawn. At the beginning and end of all exercises, there will be short-term active stretching and relaxation exercises performed by the patient as a warm-up and cool-down period. In the first 4 weeks, it is planned to increase the physical fitness levels of individuals with progressive resistance exercises and to make them suitable for aerobic loading. For each patient, the PRE, resistance will be increased from 60% to 80% for as long as the person can. At the end of the 1st month, the time allocated to resistance exercise training will be reduced and until the end of the 4th month, an increasing intensity aerobic exercise training will be given on the stationary bike.

Group Type: EXPERIMENTAL

resistance and aerobic exercise

Intervention Type: OTHER

Resistive exercises allow loading the muscle under suitable conditions with various weights or resistances. In order to increase the level of physical fitness with the increase of muscle strength and bone mass in individuals, resistance exercises were preferred. Aerobic exercises, on the other hand, are a special type of exercise that develops both the musculoskeletal system and the cardiovascular system, which includes large muscle groups and should be performed for at least 20 minutes when the heart rate accelerates at certain rates. Aerobic exercise was preferred in order to increase cardiovascular endurance, accelerate fat burning and reduce fatigue.

Home-Based Control Group

After the patients assigned to the control group are evaluated by the physiotherapist with field tests and scales for physical functions, the patients will be informed about the importance of lifestyle changes in disease management, gait training will be given to increase their physical activity level and participants will be asked to follow a 45-minute walking program every day within their own means. All patients in the control group will be followed up regularly and their activity levels will be questioned in interim evaluations by asking them to keep a weekly physical activity diary.

Group Type: ACTIVE_COMPARATOR

physical activity recommendation

Intervention Type: OTHER

Patients will be informed about the importance of lifestyle change in disease management, walking training will be given to increase their physical activity level, and participants will be asked to follow a 45-minute walking program every day within their own means.

Interventions

physical activity recommendation

Patients will be informed about the importance of lifestyle change in disease management, walking training will be given to increase their physical activity level, and participants will be asked to follow a 45-minute walking program every day within their own means.

Intervention Type: OTHER

resistance and aerobic exercise

Resistive exercises allow loading the muscle under suitable conditions with various weights or resistances. In order to increase the level of physical fitness with the increase of muscle strength and bone mass in individuals, resistance exercises were preferred. Aerobic exercises, on the other hand, are a special type of exercise that develops both the musculoskeletal system and the cardiovascular system, which includes large muscle groups and should be performed for at least 20 minutes when the heart rate accelerates at certain rates. Aerobic exercise was preferred in order to increase cardiovascular endurance, accelerate fat burning and reduce fatigue.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Birgul Kumbaroglu

Research Assistant, Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KA- 21027

Identifier Type: -

Identifier Source: org_study_id