The Effects of Tai Chi on Metabolic Dysfunction-associated Fatty Liver Disease in Middle-Aged and Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Determination of Liver Fat Content
研究概览
简要总结
Background: Metabolic dysfunction-associated fatty liver disease (MAFLD) is a liver condition primarily driven by metabolic dysfunctions that may progress to hepatitis, cirrhosis, and hepatocellular carcinoma. It is also implicated in the development of other metabolic dysfunction-related diseases. MAFLD has emerged as a growing public health concern in China. Despite its potential benefits, Tai Chi exercise has not been widely adopted for individuals with MAFLD, and there is limited research investigating its therapeutic efficacy. This study aims to evaluate the effects of a structured Tai Chi intervention on middle-aged and elderly individuals with MAFLD.
Methods: The study employs a comprehensive open, randomized, parallel, and controlled design. Eligible participants will be randomly allocated into three groups: Tai Chi, conventional exercise, and control. A total of 250 participants will be enrolled, comprising 100 participants each for the Tai Chi and conventional exercise groups and 50 for the control group. Both the Tai Chi and conventional exercise groups will participate in a structured 6-month exercise program. During the intervention, both groups will also receive regular health education on fatty liver disease. Participants will be encouraged to maintain their usual activities but will be advised against starting new exercise regimens. The control group will receive only health education on fatty liver disease. The primary efficacy endpoint is the change in hepatic triglyceride content measured via validated imaging techniques after 6 months. Secondary endpoints include changes in total body fat, waist circumference, body weight, blood pressure, blood lipids, blood glucose, insulin sensitivity, pancreatic beta-cell function, kidney function, and pulse wave velocity. Outcomes will be assessed at baseline and post-intervention.
Discussion: Tai Chi exercises demonstrate therapeutic potential in reducing intrahepatic fat content, promoting weight loss, and mitigating cardiovascular risk factors. Furthermore, their efficacy appears superior to that of conventional exercise modalities.
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
- Single (Outcomes Assessor)
盲法说明
All subjects will undergo all the prescribed baseline assessments before being randomized into groups. The personnel conducting the clinical endpoint assessments will be blinded; they will not be aware of the trial group assignments of the subjects during the measurement of clinical endpoints.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 75 years;
- •Liver fat content measured by mDixon QUANT is ≥5%;
- •Diagnosis of metabolic associated fatty liver disease;
- •Overweight/obesity (BMI ≥ 24 kg/m²);
- •Signed written informed consent.
排除标准
- •Excessive alcohol consumption (definition: in the past 6 months, males have consumed more than 140g of alcohol per week, and females have consumed more than 70g);
- •Fatty liver due to other causes: such as alcoholic fatty liver, acute and chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, etc.;
- •Severe cardiovascular diseases, including myocardial infarction within the past 6 months;
- •Heart failure (NYHA classification: III - IV);
- •Biliary diseases: such as obstructive biliary diseases;
- •Other diseases affecting glucose and lipid metabolism: diabetes, hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.;
- •Poorly controlled blood pressure: SBP ≥ 180 mmHg, DBP ≥ 100 mmHg;
- •Chronic kidney disease or severe renal impairment, defined as serum creatinine of 135 µmol/L (1.5 mg/dL) for males and 110 µmol/L (1.3 mg/dL) for females;
- •Patients unable to communicate normally, such as those with dementia or cognitive impairment;
- •Currently pregnant or planning to become pregnant in the near future;
- •Other conditions preventing participation in follow-up interventions;
- •Other clinical diseases that make participation in exercise unsuitable, such as inability to cooperate with exercise therapy due to severe pain or joint deformities, or the use of medications that may interfere with the assessment of exercise effects (such as corticosteroids, liver protection drugs, etc.), or medications that affect heart rate (such as beta-blockers).
研究组 & 干预措施
Tai Chi Exercise
Tai Chi Exercise program, five times a week .
干预措施: Tai Chi Exercise (Behavioral)
Regular Physical Activity
Each exercise session lasts for 60 minutes, five days a week.
干预措施: Regular Exercise (Behavioral)
Control
Conduct health education on fatty liver once every two months.
干预措施: Control (Behavioral)
结局指标
主要结局
Determination of Liver Fat Content
时间窗: Baseline (month 0) to post-training (month 6)
The liver is scanned using a SIEMENS 3.0T MRI (Magnetom Prisma, Siemens Healthineers, Germany). Participants lie supine, holding breath at end-expiration. A 3D multi-echo water-fat separation gradient echo sequence is used with parameters: TR 9.00 ms, TE1-6 at 1.05-7.38 ms, 4° flip angle, 450×394 mm FOV, 1.4×1.4×3.5 mm voxel size, 64 slices, 13 sec collection time. Images include in-phase, out-of-phase, water, fat, fat fraction, and R2\* relaxation. Liver fat content (%) is measured in pseudocolor mode. ROIs are selected in liver's left lobe, central right lobe, and posterior right lobe below the portal vein at two levels, each 4 cm², avoiding bile ducts and vessels. Average fat content from 9 ROIs represents total liver fat content.
次要结局
- Body weight(Baseline (month 0) to post-training (month 6))
- Waist circumference(Time Frame: Baseline (month 0) to post-training (month 6))
- Blood pressure(Baseline (month 0) to post-training (month 6))
- Grip strength of both hands(Baseline (month 0) to post-training (month 6))
- Body fat percentage(Baseline (month 0) to post-training (month 6))
- Total body fat(Baseline (month 0) to post-training (month 6))
- Liver fibrosis scanning to determine liver stiffness(Baseline (month 0) to post-training (month 6))
- Abdominal visceral fat(Baseline (month 0) to post-training (month 6))
- Blood specimen(Baseline (month 0) to post-training (month 6))
研究者
Xiling lLIN
Associate chief physician
Fujian Provincial Hospital