NCT06994871

Effects of Different Exercises on Intrahepatic Lipid in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

Effects of Aerobic or Resistance Exercise, or Both on Intrahepatic Lipid in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease: a Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease

Interventions

Type	Name	Description
OTHER	Aerobic 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.
OTHER	Resistance exercise	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.
OTHER	combined exercise	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.

Timeline

• Start date: 2025-03-09
• Primary completion: 2026-03-25
• Completion: 2026-06-20
• First posted: 2025-05-29
• Last updated: 2025-06-05

Locations

2 sites across 1 country: China