Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT06717828

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

Led by Fujian Provincial Hospital · Updated on 2024-12-05

250

Participants Needed

1

Research Sites

112 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 75 years
  • Liver fat content measured by mDixon QUANT is 5% or higher
  • Diagnosis of metabolic associated fatty liver disease
  • Overweight or obesity with BMI 24 kg/m² or higher
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Excessive alcohol consumption: males over 140g/week, females over 70g/week in past 6 months
  • Fatty liver caused by other reasons such as alcoholic fatty liver, viral hepatitis, drug-induced or autoimmune hepatitis
  • Severe cardiovascular diseases including heart attack within past 6 months
  • Heart failure classified as NYHA III-IV
  • Biliary diseases like obstructive biliary disease
  • Other diseases affecting glucose and lipid metabolism such as diabetes, thyroid disorders, or Cushing's syndrome
  • Poorly controlled blood pressure with systolic ≥180 mmHg or diastolic ≥100 mmHg
  • Chronic kidney disease or severe kidney impairment defined by specific serum creatinine levels
  • Unable to communicate normally due to dementia or cognitive impairment
  • Currently pregnant or planning pregnancy soon
  • Other conditions preventing participation or follow-up
  • Clinical diseases or medication use that interfere with exercise participation or assessment such as severe pain, joint deformities, corticosteroids, liver protection drugs, or beta-blockers

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Trial Site Locations

Total: 1 location

1

Fujian Provincial Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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