Clinical trial NCT06994234: Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease
Official title: Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Liver Stiffness Measurement (LSM)
timeFrame: Baseline, 3 months post-treatment
measure: Controlled Attenuation Parameter(CAP)
timeFrame: Baseline, 3 months post-treatment
Secondary outcomes:
measure: Polysomnography metrics
timeFrame: Baseline, 3 months post-treatment
measure: Height
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Body Weight
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Waist Circumference
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Body Fat Percentage
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Lean Body Mass
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: BMI
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: albumin
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Hemoglobin
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: body temperature
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Respiratory Rate
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Blood Pressure
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Heart Rate
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Blood White Blood Cells
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Bloos Red Blood Cells
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Platelets
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: alanine aminotransferase (ALT)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: aspartate aminotransferase (AST)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: serum creatinine (Cr)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Blood Urea Nitrogen (BUN)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Total Cholesterol (TC)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Triglycerides (TG)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: High-Density Lipoprotein Cholesterol（HDL)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Fasting Blood Glucose (FBG)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Fasting Insulin (FINS)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Hyaluronic Acid（HA)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Procollagen III N-Terminal Peptide（PIIINP)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Collagen Type IV（CIV)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Laminin（LN)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
measure: Glycated Hemoglobin (HbA1c)
timeFrame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
References: