Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT06994234
Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease
A study testing In-Place Slow Jogging in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Shanghai East Hospital at 1 site in China.
Trial summary
Evaluating the Effectiveness, Safety, and Feasibility of Stationary Ultra-Slow Running in Treating MASLD Patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- In-Place Slow Jogging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 20 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Lan L Zhong, +8613162099450, lanzhong@tongji.edu.cn
About this study
Official title: Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Randomized Controlled Trial
Evaluating the Effectiveness, Safety, and Feasibility of Stationary Ultra-Slow Running in Treating MASLD Patients.
- Being tested
- In-Place Slow Jogging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Place Slow JoggingBehavioural
ultra-jogging training was carried out 5 times a week, and each training session lasted for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Stiffness Measurement (LSM)
Measure method：FibroScan
Measured: Baseline, 3 months post-treatment
Controlled Attenuation Parameter(CAP)
Measure method：FibroScan
Measured: Baseline, 3 months post-treatment
Secondary outcomes (30)
Polysomnography metrics
Measure method:Polysomnography（PSG)
Measured: Baseline, 3 months post-treatment
Height
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Body Weight
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Waist Circumference
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Body Fat Percentage
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Lean Body Mass
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
BMI
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Total Cholesterol (TC)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Triglycerides (TG)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
High-Density Lipoprotein Cholesterol（HDL)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Fasting Blood Glucose (FBG)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Fasting Insulin (FINS)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Hyaluronic Acid（HA)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Procollagen III N-Terminal Peptide（PIIINP)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Collagen Type IV（CIV)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Laminin（LN)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Glycated Hemoglobin (HbA1c)
Measured: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start20 Jun 2025 (estimated)
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994234
- Sponsor's protocol ID
- 2025YS-079
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06994234
- Acronym / sponsor ID
- 2025YS-079
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jun 2028 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the Effectiveness, Safety, and Feasibility of Stationary Ultra-Slow Running in Treating MASLD Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Place Slow Jogging Group | Experimental | Behavioral: In-Place Slow JoggingDuring 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Place Slow Joggingultra-jogging training was carried out 5 times a week, and each training session lasted for 30 minutes. | Behavioural | In-Place Slow Jogging Group |
Primary outcome
Liver Stiffness Measurement (LSM)
Time frame: Baseline, 3 months post-treatment
Measure method：FibroScan
Controlled Attenuation Parameter(CAP)
Time frame: Baseline, 3 months post-treatment
Measure method：FibroScan
30 secondary outcomes
Polysomnography metrics
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
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Hemoglobin
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
body temperature
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Respiratory Rate
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Blood Pressure
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Heart Rate
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Blood White Blood Cells
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Bloos Red Blood Cells
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Platelets
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
alanine aminotransferase (ALT)
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
aspartate aminotransferase (AST)
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
serum creatinine (Cr)
Time frame: Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment
Blood Urea Nitrogen (BUN)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Place Slow Jogging in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lan L Zhong (+8613162099450, lanzhong@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Stiffness Measurement (LSM) (time frame: Baseline, 3 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.