Clinical trial NCT06717828: The Effects of Tai Chi on Metabolic Dysfunction-associated Fatty Liver Disease in Middle-Aged and Older Adults
Official title: The Effects of Tai Chi on Metabolic Dysfunction-associated Fatty Liver Disease in Middle-Aged and Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: MAFLD
Tai Chi
Intrahepatic Fat Content
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design utilizes an open, randomized, parallel, controlled approach. A total of 250 middle-aged and elderly subjects with metabolic associated fatty liver disease are recruited. Participants are randomly assigned in a 2:2:1 ratio to the Tai Chi group, conventional exercise group, and control group, with the entire intervention period lasting for 6 months.
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. Age between 40 and 75 years;
2. Liver fat content measured by mDixon QUANT is ≥5%;
3. Diagnosis of metabolic associated fatty liver disease;
4. Overweight/obesity (BMI ≥ 24 kg/m²);
5. Signed written informed consent.

Exclusion Criteria:

1. 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);
2. Fatty liver due to other causes: such as alcoholic fatty liver, acute and chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, etc.;
3. Severe cardiovascular diseases, including myocardial infarction within the past 6 months;
4. Heart failure (NYHA classification: III - IV);
5. Biliary diseases: such as obstructive biliary diseases;
6. Other diseases affecting glucose and lipid metabolism: diabetes, hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.;
7. Poorly controlled blood pressure: SBP ≥ 180 mmHg, DBP ≥ 100 mmHg;
8. 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;
9. Patients unable to communicate normally, such as those with dementia or cognitive impairment;
10. Currently pregnant or planning to become pregnant in the near future;
11. Other conditions preventing participation in follow-up interventions;
12. 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).

Primary outcomes:
measure: Determination of Liver Fat Content
timeFrame: Baseline (month 0) to post-training (month 6)
Secondary outcomes:
measure: Body weight
timeFrame: Baseline (month 0) to post-training (month 6)
measure: Waist circumference
timeFrame: Time Frame: Baseline (month 0) to post-training (month 6)
measure: Blood pressure
timeFrame: Baseline (month 0) to post-training (month 6)
measure: Grip strength of both hands
timeFrame: Baseline (month 0) to post-training (month 6)
measure: Body fat percentage
timeFrame: Baseline (month 0) to post-training (month 6)
measure: Total body fat
timeFrame: Baseline (month 0) to post-training (month 6)
measure: Liver fibrosis scanning to determine liver stiffness
timeFrame: Baseline (month 0) to post-training (month 6)
measure: Abdominal visceral fat
timeFrame: Baseline (month 0) to post-training (month 6)
measure: Blood specimen
timeFrame: Baseline (month 0) to post-training (month 6)
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
References: