Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease

Tongji University

Status: Not yet enrolling

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease

Treatments: Behavioral: In-Place Slow Jogging

Study type: Interventional

Funder types: Other

Identifiers

NCT06994234

2025YS-079

Details and patient eligibility

About

Evaluating the Effectiveness, Safety, and Feasibility of Stationary Ultra-Slow Running in Treating MASLD Patients.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meeting the diagnostic criteria for MASLD.
2. Aged between 18 and 70 years (inclusive), regardless of gender.
3. Patients voluntarily participate in this clinical study, have signed the informed consent form, and agree to comply with all study requirements, including follow-up visits, examinations, and treatments.

Exclusion criteria

1. Exclusion of other conditions causing liver injury, including alcoholic hepatitis, active hepatitis B or C virus infection, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, Wilson's disease, α1-antitrypsin deficiency, liver cancer (or family history of liver cancer), etc.
2. History of medication use for more than 2 weeks within the past year that may induce hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogen exceeding hormone replacement doses, anabolic steroids, valproic acid, or other known hepatotoxins).
3. Use of hepatoprotective drugs (including but not limited to reduced glutathione, glucurolactone, glycyrrhizin preparations, nicotinamide, bifendate, liver-protecting tablets, silymarin, polyene phosphatidylcholine, S-adenosylmethionine, ursodeoxycholic acid, vitamin E, or other herbal medicines affecting liver function) within 4 weeks prior to enrollment.
4. Presence of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or history of liver transplantation at randomization or previously, or planned liver transplantation.
5. Concurrent type 1 diabetes.
6. Severe cardiovascular, cerebrovascular, renal, or hematopoietic system diseases, as well as mood disorders (e.g., anxiety, depression) or psychiatric illnesses.
7. Patients with any type of malignancy or a history of malignancy.
8. HIV-positive status.
9. Pregnant or breastfeeding women, or subjects of childbearing potential unwilling or unable to use effective contraception from the screening period until 6 months after discontinuation of the investigational drug.
10. Participation in other interventional clinical trials within 12 weeks prior to screening.
11. Patients with unstable weight (i.e., weight loss or gain exceeding 4 kg in the past 3 months) or those with conditions preventing participation in the exercise program.
12. Other conditions deemed by the investigator as unsuitable for participation in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

In-Place Slow Jogging Group

Experimental group

Description:

During the 3-month intervention period, the diet followed the outpatient health prescription of MASLD, and ultra-jogging training was carried out 5 times a week, and each training session lasted for 30 minutes.

Treatment:

Behavioral: In-Place Slow Jogging

Control Group

No Intervention group

Description:

During the 3-month intervention period, the diet followed the health prescription of our MASLD outpatient clinic, and patients were encouraged to maintain their daily physical activity level, such as walking up and down stairs, walking short distances, etc. However, there is no in-situ ultra-jogging intervention.