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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 start with a warm-up and include a review of Tai Chi principles and movements, breathing techniques, and relaxation methods. Participants will document their Tai Chi practice over 24 weeks by submitting exercise weekly logs, while researchers will monitor their exercise progress weekly via phone using standardized forms to assess frequency, completion status, adverse events, and adherence.

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 and fitness trackers.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Determination of Liver Fat Content — 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.

Trial sites (1)

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