The Effects of Tai Chi on Metabolic Dysfunction-associated Fatty Liver Disease in Middle-Aged and Older Adults

Обзор

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.

Вмешательства

• Поведенческое Tai Chi Exercise
  Tai Chi is a moderate-intensity exercise suitable for middle-aged and elderly individuals. Participants will engage in the practice five times a week (three sessions will be in-person teaching, and two will be online), with each session lasting 60 minutes, continuing until the end of a six-month follow-up. Before the intervention begins, participants will receive a manual or instructional video on Tai Chi to understand its principles, practice techniques, and safety precautions. Each class will
• Поведенческое Regular Exercise
  The intervention for middle-aged and elderly individuals includes a combination of common activities: 15 minutes of walking, 15 minutes of body coordination activities (including limb movements and balance training), 15 minutes of muscle stretching, and 15 minutes of relaxation. Each exercise session lasts for 60 minutes, conducted five days a week. The heart rate during exercise will be adjusted based on monthly fitness assessments, and the daily activity level will be evaluated through logs an
• Поведенческое Control
  All participants will be advised not to change their existing lifestyle habits and will only receive health education related to fatty liver throughout the intervention. The educational methods will include large group sessions, individual education, and telephone follow-ups, conducted every two months. Additionally, dietary and exercise assessments will be carried out during the intervention, with dietary intake recorded using a three-day food diary to track daily calorie consumption.

Первичные конечные точки

• Determination of Liver Fat Content [Срок оценки: Baseline (month 0) to post-training (month 6)]

Вторичные конечные точки (9)

• Body weight [Срок оценки: Baseline (month 0) to post-training (month 6)]
• Waist circumference [Срок оценки: Time Frame: Baseline (month 0) to post-training (month 6)]
• Blood pressure [Срок оценки: Baseline (month 0) to post-training (month 6)]
• Grip strength of both hands [Срок оценки: Baseline (month 0) to post-training (month 6)]
• Body fat percentage [Срок оценки: Baseline (month 0) to post-training (month 6)]
• Total body fat [Срок оценки: Baseline (month 0) to post-training (month 6)]
• Liver fibrosis scanning to determine liver stiffness [Срок оценки: Baseline (month 0) to post-training (month 6)]
• Abdominal visceral fat [Срок оценки: Baseline (month 0) to post-training (month 6)]
• Blood specimen [Срок оценки: Baseline (month 0) to post-training (month 6)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fujian Provincial Hospital — Фучжоу

Идентификаторы

NCT: NCT06717828 · 202410081053000483865

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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