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

NCT ID: NCT06994234

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2028-06-20

Brief Summary

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

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

In-Place Slow Jogging Group

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.

Group Type: EXPERIMENTAL

In-Place Slow Jogging

Intervention Type: BEHAVIORAL

ultra-jogging training was carried out 5 times a week, and each training session lasted for 30 minutes.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

In-Place Slow Jogging

ultra-jogging training was carried out 5 times a week, and each training session lasted for 30 minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Lan L Zhong

Role: CONTACT

lanzhong@tongji.edu.cn

+8613162099450

Facility Contacts

Lan L Zhong

Role: primary

lanzhong@tongji.edu.cn

+8613162099450

Other Identifiers

2025YS-079

Identifier Type: -

Identifier Source: org_study_id