Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 7:08 PM
Study NCT ID:
NCT06994234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver Stiffness Measurement (LSM)', 'timeFrame': 'Baseline, 3 months post-treatment', 'description': 'Measure method：FibroScan'}, {'measure': 'Controlled Attenuation Parameter(CAP)', 'timeFrame': 'Baseline, 3 months post-treatment', 'description': 'Measure method：FibroScan'}], 'secondaryOutcomes': [{'measure': 'Polysomnography metrics', 'timeFrame': 'Baseline, 3 months post-treatment', 'description': 'Measure method:Polysomnography（PSG)'}, {'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', 'description': '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'}, {'measure': 'Hemoglobin', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': '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'}, {'measure': 'body temperature', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': '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'}, {'measure': 'Respiratory Rate', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': '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.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': 'The unit is millimeters of mercury (mmHg). Normal range: systolic pressure, 90-139 mmHg; diastolic pressure, 60-89 mmHg.'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': 'The unit is beats per minute (beats/min). Normal range: 60-100 beats/min (at rest).'}, {'measure': 'Blood White Blood Cells', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': '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.'}, {'measure': 'Bloos Red Blood Cells', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': 'Normal range is 4.3-5.8×10¹²/L for males and 3.8-5.1×10¹²/L for females.'}, {'measure': 'Platelets', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': 'Normal range is 125-350×10⁹/L. A reduced count increases the risk of bleeding, while an elevated count increases the risk of thrombosis.'}, {'measure': 'alanine aminotransferase (ALT)', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': 'Normal range is 7-40 U/L. Elevated levels indicate liver damage.Time'}, {'measure': 'aspartate aminotransferase (AST)', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': 'Normal range is 13-35 U/L. Elevated levels indicate liver damage.'}, {'measure': 'serum creatinine (Cr)', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': 'Normal range is 53-106 μmol/L for males and 44-97 μmol/L for females. Elevated levels suggest decreased renal function.'}, {'measure': 'Blood Urea Nitrogen (BUN)', 'timeFrame': 'Baseline, 1 months post-treatment, 2 months post-treatment, 3 months post-treatment', 'description': 'Normal range is 2.9-7.5 mmol/L. Elevated levels may be associated with renal failure or dehydration.'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Dysfunction-Associated Steatotic Liver Disease']}, 'descriptionModule': {'briefSummary': 'Evaluating the Effectiveness, Safety, and Feasibility of Stationary Ultra-Slow Running in Treating MASLD Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for MASLD.\n2. Aged between 18 and 70 years (inclusive), regardless of gender.\n3. 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.\n\nExclusion Criteria:\n\n1. 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.\n2. 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).\n3. 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.\n4. Presence of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or history of liver transplantation at randomization or previously, or planned liver transplantation.\n5. Concurrent type 1 diabetes.\n6. Severe cardiovascular, cerebrovascular, renal, or hematopoietic system diseases, as well as mood disorders (e.g., anxiety, depression) or psychiatric illnesses.\n7. Patients with any type of malignancy or a history of malignancy.\n8. HIV-positive status.\n9. 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.\n10. Participation in other interventional clinical trials within 12 weeks prior to screening.\n11. 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.\n12. Other conditions deemed by the investigator as unsuitable for participation in this study."}, 'identificationModule': {'nctId': 'NCT06994234', 'briefTitle': 'Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai East Hospital'}, 'officialTitle': 'Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025YS-079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In-Place Slow Jogging Group', 'description': '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.', 'interventionNames': ['Behavioral: In-Place Slow Jogging']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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': [{'name': 'In-Place Slow Jogging', 'type': 'BEHAVIORAL', 'description': 'ultra-jogging training was carried out 5 times a week, and each training session lasted for 30 minutes.', 'armGroupLabels': ['In-Place Slow Jogging Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Lan L Zhong', 'role': 'CONTACT', 'email': 'lanzhong@tongji.edu.cn', 'phone': '+8613162099450'}], 'facility': 'Shanghai East Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lan L Zhong', 'role': 'CONTACT', 'email': 'lanzhong@tongji.edu.cn', 'phone': '+8613162099450'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}