Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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In Taiwan, with the westernization of eating habit and lifestyle, metabolic syndrome and non-alcoholic fatty liver (NAFLD) have become very important health issues. This project will therefore study the histological and clinical data of patients with non-alcoholic fatty liver disease and explore the impact of exercise intervention on the hepatic fatty infiltration of the patients. The research strategy will include (1) combining modern artificial big data collection technology to fully monitor the daily life, sleep and exercise patterns of the participants; (2) improving fatty liver and metabolic syndrome through trial-based exercise intervention; and (3) exploring the changes of sleep patterns and intestinal microflora in patients with metabolic liver disease after exercise intervention.

Detailed Description
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Background & aims: In Taiwan, with the investigators sternization of eating habit and lifestyle, metabolic syndrome and non-alcoholic fatty liver (NAFLD) have become very important health issues. This project will therefore study the histological and clinical data of patients with non-alcoholic fatty liver disease and explore the impact of exercise intervention on the hepatic fatty infiltration of the patients. The research strategy will include (1) combining modern artificial big data collection technology to fully monitor the daily life, sleep and exercise patterns of the participants; (2) improving fatty liver and metabolic syndrome through trial-based exercise intervention; and (3) exploring the changes of sleep patterns and intestinal microflora in patients with metabolic liver disease after exercise intervention. Materials & methods: The investigators will first retrospective collect clinical and histologic data of patients with biopsy proven NAFLD. Second, the investigators will establish a non-invasive fatty liver detection and staging platform at National Taiwan University Hospital. The investigators then plan to enroll 100 patients with non-alcoholic fatty liver from NTUH employees. The investigators will collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening. After one year of exercise intervention, the investigators will analyze the effect of exercise on intrahepatic fat (main parameter: 20% reduction in intrahepatic fat; 30% achieved in the exercise intervention group; 5% achieved in the control group) and related metabolic syndrome indicators, and analyze different types of exercise Whether the intervention has different effects, and analyze the improvement of sleep pattern and intestinal microflora after exercise intervention.

Official Title
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Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease

Conditions
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Fatty Liver, NAFLD

Intervention / Treatment
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* Other: exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-alcoholic fatty liver from NTUH employees Exclusion Criteria: not suitable for exercise (severe cardiovascular disease or severe limb and joint disease), patients with inherited hyperlipidemia (diabetes> 300 mg / dL or low-density lipoprotein cholesterol> 190 mg / dL or cardiovascular disease has occurred before the age of 60 )event). women exclude pregnancy and breastfeeding. liver cancer, AFP> 20 ng/ml. alcohol and drug abusers. the use of steroids, sex hormones, immunosuppressants, radiation exposure and chemotherapy within 3 months.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The investigators will collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The effects of exercise intervention on fatty liver<br>The effects of exercise intervention on fatty liver and the improvement of the above-mentioned various metabolic indicators, including improvement of sleep patterns and changes of intestinal microflora. | Other: exercise<br>* Collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% reduction in intrahepatic fat | We aim to evaluate whether active exercise can help reduce the fat content of the liver. After 24-week exercise intervention, the effect of exercise on the reduction of intrahepatic fat content in cases (active exercise) versus controls (no exercise) will be assessed by MRS/PDFF | 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of intrahepatic fibrosis | We also aim to evaluate whether active exercise can help reduce the fibrosis of the liver. After 24-week exercise intervention, the effect of exercise on the reduction of intrahepatic fat content in cases (active exercise) versus controls (no exercise) will be assessed by Fibroscan examination. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLED