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

NCT06994234 | Not Yet Recruiting

• 1 other identifier: 2025YS-079
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Outcome Measures

Primary Outcomes (2)

• Liver Stiffness Measurement (LSM)

  Measure method：FibroScan

  Baseline, 3 months post-treatment

• Controlled Attenuation Parameter(CAP)

  Measure method：FibroScan

  Baseline, 3 months post-treatment

Secondary Outcomes (30)

• Polysomnography metrics

  Baseline, 3 months post-treatment

• Height

  Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

• Body Weight

  Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

• Waist Circumference

  Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

• Body Fat Percentage

  Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Study Arms (2)

In-Place Slow Jogging Group

EXPERIMENTAL

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.

Behavioral: In-Place Slow Jogging

Control Group

NO INTERVENTION

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.

Interventions

In-Place Slow Jogging BEHAVIORAL

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

In-Place Slow Jogging Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the diagnostic criteria for MASLD.
• Aged between 18 and 70 years (inclusive), regardless of gender.
• 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.

You may not qualify if:

• 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).
• 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.
• Presence of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or history of liver transplantation at randomization or previously, or planned liver transplantation.
• Concurrent type 1 diabetes.
• Severe cardiovascular, cerebrovascular, renal, or hematopoietic system diseases, as well as mood disorders (e.g., anxiety, depression) or psychiatric illnesses.
• Patients with any type of malignancy or a history of malignancy.
• HIV-positive status.
• 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.
• Participation in other interventional clinical trials within 12 weeks prior to screening.
• 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.
• Other conditions deemed by the investigator as unsuitable for participation in this study.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Central Study Contacts

Lan L Zhong

CONTACT

+8613162099450; lanzhong@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): June 20, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)