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

NCT06717828 | Recruiting DMC

• 1 other identifier: 202410081053000483865
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

MAFLD; Tai Chi; Intrahepatic Fat Content

Outcome Measures

Primary Outcomes (1)

• Determination of Liver Fat Content

  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.

  Baseline (month 0) to post-training (month 6)

Secondary Outcomes (9)

• Body weight

  Baseline (month 0) to post-training (month 6)

• Waist circumference

  Time Frame: Baseline (month 0) to post-training (month 6)

• Blood pressure

  Baseline (month 0) to post-training (month 6)

• Grip strength of both hands

  Baseline (month 0) to post-training (month 6)

• Body fat percentage

  Baseline (month 0) to post-training (month 6)

Study Arms (3)

Tai Chi Exercise

EXPERIMENTAL

Tai Chi Exercise program, five times a week .

Behavioral: Tai Chi Exercise

Regular Physical Activity

EXPERIMENTAL

Each exercise session lasts for 60 minutes, five days a week.

Behavioral: Regular Exercise

Control

OTHER

Conduct health education on fatty liver once every two months.

Behavioral: Control

Interventions

Tai Chi Exercise BEHAVIORAL

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.

Tai Chi Exercise

Regular Exercise BEHAVIORAL

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.

Regular Physical Activity

Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All subjects will undergo all the prescribed baseline assessments before being randomized into groups. The personnel conducting the clinical endpoint assessments will be blinded; they will not be aware of the trial group assignments of the subjects during the measurement of clinical endpoints.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CN (1)