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

N/ANot Yet RecruitingNCT06994234

Shanghai East Hospital82 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Interventions

In-Place Slow JoggingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Liver Stiffness Measurement (LSM)

Measure method：FibroScan

Time frame: Baseline, 3 months post-treatment

Controlled Attenuation Parameter(CAP)

Measure method：FibroScan

Time frame: Baseline, 3 months post-treatment

Secondary Outcomes

Polysomnography metrics

Measure method:Polysomnography（PSG)

Time frame: Baseline, 3 months post-treatment

Height

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Body Weight

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Waist Circumference

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Body Fat Percentage

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Lean Body Mass

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

BMI

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

albumin

The unit is grams per liter (g/L). It reflects liver synthetic function and nutritional status. Normal reference values are 35-50 g/L for adults and 34-48 g/L for individuals aged 60 years or older.Time

Central Contacts

Lan L Zhong

CONTACT

+8613162099450 lanzhong@tongji.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Hemoglobin

The unit is grams per liter (g/L). It is used to assess anemia or polycythemia. Normal reference values are as follows: adult males: 120-160 g/L; adult females: 110-150

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

body temperature

The unit is degrees Celsius (℃). Normal range: axillary temperature is 36℃ to 37℃.Time Frame: Baseline, at 1 week, 4 weeks, 8 weeks, and 12 weeks after

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Respiratory Rate

The unit is breaths per minute (breaths/min). Normal range: adults, 16-20 breaths/min (at rest).Tachypnea may be caused by reasons such as pneumonia, fever, cardiovascular diseases, anemia, etc., while bradypnea may be caused by reasons such as increased intracranial pressure, hypothyroidism, etc.

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Blood Pressure

The unit is millimeters of mercury (mmHg). Normal range: systolic pressure, 90-139 mmHg; diastolic pressure, 60-89 mmHg.

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Heart Rate

The unit is beats per minute (beats/min). Normal range: 60-100 beats/min (at rest).

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Blood White Blood Cells

Normal range for adults is 4.0-10.0×10⁹/L. An elevated level may indicate bacterial infection or inflammation, while a decreased level may be associated with viral infections or drug reactions.

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Bloos Red Blood Cells

Normal range is 4.3-5.8×10¹²/L for males and 3.8-5.1×10¹²/L for females.

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Platelets

Normal range is 125-350×10⁹/L. A reduced count increases the risk of bleeding, while an elevated count increases the risk of thrombosis.

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

alanine aminotransferase (ALT)

Normal range is 7-40 U/L. Elevated levels indicate liver damage.Time

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

aspartate aminotransferase (AST)

Normal range is 13-35 U/L. Elevated levels indicate liver damage.

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

serum creatinine (Cr)

Normal range is 53-106 μmol/L for males and 44-97 μmol/L for females. Elevated levels suggest decreased renal function.

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Blood Urea Nitrogen (BUN)

Normal range is 2.9-7.5 mmol/L. Elevated levels may be associated with renal failure or dehydration.

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Total Cholesterol (TC)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Triglycerides (TG)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

High-Density Lipoprotein Cholesterol（HDL)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Fasting Blood Glucose (FBG)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Fasting Insulin (FINS)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Hyaluronic Acid（HA)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Procollagen III N-Terminal Peptide（PIIINP)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Collagen Type IV（CIV)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Laminin（LN)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment

Glycated Hemoglobin (HbA1c)

Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment