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Exercise Therapy for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Multi-Center, Randomized Controlled Trial

Exercise Therapy for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Multi-Center, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120092
Enrollment
Unknown
Registered
2026-03-09
Start date
2026-03-09
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Interventions

Experimental group:During the study period, all the subjects strictly abstained from alcohol and underwent exercise intervention according to the exercise prescription. The exercise intervention plan
in the third to 16th weeks, it was 50-70% of the maximum metabolic equivalent, 4 times a week, each lasting 30 minutes. Resistance training was conducted at 30-60% of the one-repetition maximum (1RM),
in the third to 16th weeks, it was 50-60% of the one-repetition maximum (1RM), 12-15 repetitions per group, 2-3 groups, 4 times a week. The study provided a favorable environment for patients, and the
Control group:The subjects received health education related to MASLD. The exercise form was not restricted, and they strictly abstained from alcohol throughout the study period. Physical fitness test

Sponsors

Zhongda Hospital, Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age between 40 and 70 years. 2. Diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD), defined by a magnetic resonance imaging proton density fat fraction (MRI-PDFF) >=5%, and the presence of at least one cardiovascular metabolic risk factor: (1) Body mass index (BMI) >=24 kg/m^2 or waist circumference >90 cm (for men) / >85 cm (for women); (2) Fasting plasma glucose (FPG)>=5.6 mmol/L, or 2-hour postprandial glucose (2h-PG) >=7.8 mmol/L, or hemoglobin A1c>=5.7%, or type 2 diabetes (T2DM) or T2DM under treatment; (3) Blood pressure>=130/85 mmHg or use of antihypertensive medications; (4) Triglycerides (TG)>=1.7 mmol/L or use of lipid-lowering medications; (5) High-density lipoprotein cholesterol (HDL-C) =3.14 kPa as assessed by magnetic resonance elastography (MRE). 4. Ability to undergo magnetic resonance imaging (MRI) without contraindications, such as pacemakers or implanted metal devices. 5. Willingness to provide voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1. MRE measures LSM >= 4.45 kPa (indicating liver cirrhosis); 2. History of decompensated liver cirrhosis; 3. Diagnosis of liver cancer or other malignant tumors; 4. Pregnancy or lactation; 5. Exercise-related contraindications: (1) Recent resting electrocardiogram shows severe myocardial ischemia, acute myocardial infarction (within 2 days) or other acute heart disease events; (2) Uncontrolled arrhythmias that cause symptoms or hemodynamic changes; (3) Severe, symptomatic aortic stenosis; (4) Uncontrolled, symptomatic heart failure; (5) Acute pulmonary embolism or pulmonary infarction; (6) Acute myocarditis or pericarditis; (7) Suspected or confirmed rupture of an aneurysm; (8) Acute systemic infection, accompanied by fever, generalized pain or lymph node enlargement. (9) Left coronary artery stenosis; (10) Moderate stenotic valvular heart disease; (11) Electrolyte disturbances (hypokalemia, hypomagnesemia); (12) Tachycardia or bradycardia; (13) Hypertrophic cardiomyopathy or other forms of outflow tract stenosis; (14) Severe conduction block; (15) Ventricular aneurysm; (16) Neuro-muscular, musculoskeletal or rheumatic diseases that worsen during exercise; (17) Uncontrolled metabolic diseases (such as diabetes, hyperthyroidism or myxedema); (18) Significant reduction in motor ability caused by mental or physical disorders.

Design outcomes

Primary

MeasureTime frame
Change in liver stiffness;

Secondary

MeasureTime frame
Liver function;Blood lipids;Fasting Plasma Glucose ;Glycated Hemoglobin (HbA1c);Psychological state;Hepatic fat;Body composition analysis;

Countries

China

Contacts

Public ContactQi Xiaolong

Zhongda Hospital, Southeast University

qixiaolong@vip.163.com+86 25 8327 2015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026