An interventional study of Aerobic exercise and Resistance exercise in Metabolic Dysfunction-Associated Steatotic Liver Disease, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Enrolling by invitation at 2 sites in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Not applicable, Interventional, and Treatment
This is a single-center, randomized, parallel controlled study to explore the effects of aerobic exercise, resistance exercise or aerobic combined resistance exercise on liver lipid in patients with MASLD, consisting of a 12-week core study followed by a 12-month extension phase.
This study was a single-center, randomized, parallel controlled clinical study. It conducted a 12-week exercise intervention for patients with MASLD, aiming to explore the effects of different exercise patterns for patients with MASLD. All subjects were randomly assigned to aerobic exercise, resistance exercise or aerobic combined resistance exercise groups. The liver lipid content was evaluated by MRI-PDFF values at baseline and 12 weeks after intervention. Liver function was evaluated by liver transaminase at baseline and 12 weeks after intervention. The degree of liver fibrosis was evaluated by MRE, LSM value and FIB-4 index at baseline and 12 weeks after intervention. The changes of body weight and body fat before and after the intervention were evaluated by Inbody-770, and the changes of muscle mass before and after the intervention were evaluated by DXA. The effects of different exercise methods on metabolic indexes were evaluated by the changes of blood glucose, glycated hemoglobin, insulin and blood lipid before and after the intervention. In addition, after the exercise intervention, this study plans to conduct a 12-month long-term follow-up.
Exclusion Criteria:
The subjects receive aerobic exercise for 12 weeks.
Other: Aerobic exercise
The subjects receive resistance exercise for 12 weeks.
Other: Resistance exercise
The subjects receive both aerobic and resistance exercise for 12 weeks.
Other: combined exercise
Intensity of exercise：Subjects conduct an aerobic exercise at 40-59% heart rate reserve(HRR). Time of aerobic exercise：from 30 to 45 minutes each day, five days a week.
The resistance exercise was consisted of equipment trainings and body weight trainings. Participants are required to exercise 3 times a week. Intensity of equipment trainings: 70% 1-RM. Exercise volume: 15-20 repetitions for a set, from 2 sets to 4 sets gradually. Body weight trainings: 15-30 repetitions for a set, from 2 sets to 4 sets gradually.
Subjects conduct both aerobic and resistance trainings. Details of aerobic training session: Subjects conduct an aerobic exercise at 40-59% heart rate reserve(HRR) from 50-55 minutes each day, 3-4 days a week. Details of resistance training session: The resistance exercise was consisted of equipment trainings and body weight trainings. Participants are required to exercise 2 times a week.
Changes of intrahepatic triglyceride contents
The changes of intrahepatic triglyceride contents were measured by MRI-PDFF.
Time frame: Baseline, 12 weeks
the proportions of MRI-PDFF response
the proportions of participants achieving at least 30% and at least 50% relative reduction in MRI-PDFF and MRI-PDFF \<5% at week 12
Time frame: baseline, 12 weeks
Changes of liver fibrosis
The changes of liver fibrosis were measured by MRE.
Time frame: Baseline, 12 weeks
Changes of liver transaminase
The changes of liver transaminase were measured by ALT, AST, γ-GGT, ALP.
Time frame: Baseline, 12 weeks
Changes of liver fibrosis degree
The changes of liver fibrosis were measured by LSM.
Time frame: Baseline, 12 weeks
Changes of FIB-4 index
The changes of liver fibrosis can be measured by FIB-4 index.
Time frame: Baseline, 12 weeks
Changes of body weight
The changes of body weight were measured by InBody-770 equipment.
Time frame: Baseline, 12 weeks
Changes of body fat
The changes of body fat were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry.
Time frame: Baseline, 12 weeks
Changes of muscle mass
The changes of muscle mass were measured by InBody-770 equipment and dual-energy X-ray absorptionmetry.
Time frame: Baseline, 12 weeks
Changes of muscle function
The changes of muscle function were measured by strength test using athletic equipments.
Time frame: Baseline, 12 weeks
Changes of HbA1c.
The changes of glucose metabolism indexes were measured by HbA1c.
Time frame: Baseline, 12 weeks
Changes of blood glucose
The changes of glucose metabolism indexes were measured by blood glucose.
Time frame: Baseline, 12 weeks
Changes of blood insulin
The changes of glucose metabolism indexes were measured by blood insulin.
Time frame: Baseline, 12 weeks
Changes of lipid metabolism indexes
The changes of lipid metabolism indexes were measured by triglyceride, total cholesterol, high-density and low-density lipoprotein-cholesterol.
Time frame: Baseline, 12 weeks
Change of cardiorespiratory fitness
The change of cardiorespiratory fitness assessed using peak oxygen uptake
Time frame: baseline, week 12
Incidence of Adverse Events
Participants with ≥1 AE, SAE, exercise-related AE, musculoskeletal injury, symptomatic hypoglycemia, or intervention discontinuation because of an AE
Time frame: From Baseline to Week 12
Change of cardiac autonomic function
Change of HRV and cardiovascular autonomic reflex indices assessed by the R6000 system (REEM Healthcare Co., Shenzhen, China).
Time frame: Baseline, week 12
Change of additional glucose related parameters
changes in continuous glucose monitoring (CGM)-related parameters
Time frame: baseline, Week 12
Change of metabolomics
the changes in serum metabolomics
Time frame: baseline, week12
Plan to share: No
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School