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NCT Number: NCT06994234

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

In-Place Slow Jogging

Behavioral

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

Primary outcomes

  1. Liver Stiffness Measurement (LSM)

    Time frame: Baseline, 3 months post-treatment

    Measure method:FibroScan

  2. Controlled Attenuation Parameter(CAP)

    Time frame: Baseline, 3 months post-treatment

    Measure method:FibroScan

Secondary outcomes

  1. Polysomnography metrics

    Time frame: Baseline, 3 months post-treatment

    Measure method:Polysomnography(PSG)

  2. Height

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

  3. Body Weight

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

  4. Waist Circumference

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

  5. Body Fat Percentage

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

  6. Lean Body Mass

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

  7. BMI

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

  8. albumin

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

    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

  9. Hemoglobin

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

    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

  10. body temperature

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

    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

  11. Respiratory Rate

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

    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.

  12. Blood Pressure

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

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

  13. Heart Rate

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

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

  14. Blood White Blood Cells

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

    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.

  15. Bloos Red Blood Cells

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

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

  16. Platelets

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

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

  17. alanine aminotransferase (ALT)

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

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

  18. aspartate aminotransferase (AST)

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

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

  19. serum creatinine (Cr)

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

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

  20. Blood Urea Nitrogen (BUN)

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

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

  21. Total Cholesterol (TC)

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

  22. Triglycerides (TG)

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

  23. High-Density Lipoprotein Cholesterol(HDL)

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

  24. Fasting Blood Glucose (FBG)

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

  25. Fasting Insulin (FINS)

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

  26. Hyaluronic Acid(HA)

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

  27. Procollagen III N-Terminal Peptide(PIIINP)

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

  28. Collagen Type IV(CIV)

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

  29. Laminin(LN)

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

  30. Glycated Hemoglobin (HbA1c)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lan L Zhong

CONTACT

[email protected]

+8613162099450

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Official study title

Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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