Investigation of Effectiveness of Different Exercise Types, and Their Therapeutic Effect Mechanisms and the Roles of Motivational Interview in the Treatment of Non-Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change in the liver steatosis grade
研究概览
简要总结
The goal of this 12-week clinical trial is to investigate the effectiveness of different exercise types in treating Non-Alcoholic Fatty Liver Disease (NAFLD) and to explore their impact on myokine levels associated with lipid metabolism. The main questions it aims to answer are:
- How does the type and dose of exercise affect the treatment of NAFLD?
- What is the influence of exercise interventions in NAFLD treatment on myokine levels related to lipid metabolism?
- How does motivational interviewing contribute to lifestyle modification in the treatment of NAFLD?
Participants in this study will engage in assigned exercise routines randomly, including HIIT, resistance training, or FATmax exercises. Additionally, motivational interviewing techniques will be employed to assess their impact on lifestyle changes. Researchers will compare the outcomes among the different exercise groups, along with a control group receiving only standard care for NAFLD. This comparison aims to determine the respective effects of these interventions on both NAFLD and associated myokine levels.
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
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have received a diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD)
- •Age between 25 and 50 years old
- •Use of smartphone
- •Fall into category A or B according to the American Heart Association Risk Assessment Criteria
排除标准
- •Viral hepatitis
- •Excessive alcohol consumption (more than 30 grams per day for men and more than 20 grams per day for women)
- •Use of specific medications: amiodarone, corticosteroids, methotrexate, tamoxifen, synthetic estrogen, valproic acid, intravenous tetracycline, and highly active antiretroviral drugs
- •Presence of accompanying chronic diseases such as Wilson's disease, hemochromatosis, and celiac disease
- •Liver storage diseases
- •Cirrhosis
- •Advanced changes in liver ultrasonography evaluations, such as fibrosis
- •Presence of other chronic diseases (kidney failure, heart failure, atherosclerotic heart disease, hypertension, arrhythmia disorders)
- •BMI greater than 40 kg/m²
- •History of surgery or trauma in the last 6 months
- •Orthopedic and/or neurological impairment
- •Health problems that may hinder participation in the exercise program
- •Regular and continuous participation in sports or exercise at least 3 times a week for the past 3 years
- •Family history of coronary artery disease (coronary artery disease before the age of 45 in male first-degree relatives and other male relatives, or before the age of 65 in female first-degree relatives and other female relatives)
- •Presence of specific symptoms during medical history or physical examination: chest pain radiating to the neck, jaw, or arm, shortness of breath during rest or physical activity, dizziness, fainting, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, palpitations or tachycardia, intermittent claudication, heart murmur, unexplained excessive fatigue
- •Fall into category C or D according to the American Heart Association Risk Assessment Criteria
研究组 & 干预措施
Resistance Exercise and Motivational Interviewing Group
In addition to formulating a resistance exercise prescription for individuals under standard care with liver fat accumulation, motivational interviewing principles will be applied.
干预措施: Motivational Interviewing (Behavioral)
Control Group
This group will consist of individuals with liver fat accumulation under standard care and no exercise intervention will be implemented.
Fatmax Exercise Group
Individuals with liver fat accumulation under standard care will have their Fatmax values calculated and an exercise prescription will be designed accordingly.
干预措施: Exercise (Other)
Fatmax Exercise and Motivational Interviewing Group
In addition to the prescription of Fatmax exercise for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied.
干预措施: Exercise (Other)
Fatmax Exercise and Motivational Interviewing Group
In addition to the prescription of Fatmax exercise for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied.
干预措施: Motivational Interviewing (Behavioral)
HIIT Group
Individuals with liver fat accumulation under standard care will be provided with a High-Intensity Interval Training (HIIT) exercise prescription.
干预措施: Exercise (Other)
HIIT and Motivational Interviewing Group
In addition to formulating a High-Intensity Interval Training (HIIT) exercise prescription for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied.
干预措施: Exercise (Other)
HIIT and Motivational Interviewing Group
In addition to formulating a High-Intensity Interval Training (HIIT) exercise prescription for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied.
干预措施: Motivational Interviewing (Behavioral)
Resistance Exercise Group
Individuals with liver fat accumulation under standard care will be provided with a resistance exercise prescription.
干预措施: Exercise (Other)
Resistance Exercise and Motivational Interviewing Group
In addition to formulating a resistance exercise prescription for individuals under standard care with liver fat accumulation, motivational interviewing principles will be applied.
干预措施: Exercise (Other)
结局指标
主要结局
Change in the liver steatosis grade
时间窗: 12-week
Changes in the level of liver fat accumulation in radiological abdominal ultrasonography (USG) will be observed. The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
次要结局
- ALT(12-week)
- LDL(12-week)
- CRP(12-week)
- Changes in body mass index(12-week)
- GGT(12-week)
- Free fatty acids(12-week)
- Changes in The 5 Times Sit-to-Stand Test results(12-week)
- Changes in Single Leg Standing Test results(12-week)
- Changes in the serum levels of myokines(12-week)
- ESR(12-week)
- Changes in body weight(12-week)
- AST(12-week)
- HDL(12-week)
- Total cholesterol(12-week)
- Changes in lean body mass(12-week)
- Changes in body fat percentage(12-week)
- Changes in peak oxygen consumption(12-week)
- Changes in peak heart rate(12-week)
- Triglycerides(12-week)
- Changes in waist-to-hip ratio(12-week)
- Changes in muscle strength analysis results(12-week)
- Changes in FATmax levels(12-week)
- Changes in Healthy Lifestyle Habits Scale II scores(12-week)
- Changes in anaerobic threshold(12-week)
- Changes in basal metabolic rate(12-week)
- Changes in Short Form Survey (SF-36) scores(12-week)
- Changes in Beck Depression Scale scores(12-week)
- Changes in Pittsburgh Sleep Quality Index scores(12-week)