NCT06717828Recruiting
The Effects of Tai Chi on Metabolic Dysfunction-associated Fatty Liver Disease in Middle-Aged and Older Adults
Source: ClinicalTrials.gov · Last updated 5 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 1 Dec 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fujian Provincial Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06717828
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 1 Nov 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Patients unable to communicate normally, such as those with dementia or cognitive impairment;
- 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).
Lab values
- Other diseases affecting glucose and lipid metabolism: diabetes, hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.;
- 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;
Other
- 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);
- Poorly controlled blood pressure: SBP ≥ 180 mmHg, DBP ≥ 100 mmHg;
- Currently pregnant or planning to become pregnant in the near future;
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Provincial Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.