Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT06379204
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2024-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak oxygen uptake', 'timeFrame': 'From enrollment to the end of 12 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome X']}, 'descriptionModule': {'briefSummary': 'Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Compare the effects of the two on the cardiovascular endurance of the MS population and verify the effectiveness of individualized methods in reducing absolute exercise intensity for MS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients were included who met the Chinese Diabetic Society diagnostic criteria for MS-i.e., three or more of the following five items: (i) abdominal obesity (i.e., central obesity) with waist circumference ≥ 90 cm in males and ≥ 85 cm in females; (ii) hyperglycemia defined as fasting blood glucose ≥ 6.1 mmol/L or blood glucose ≥ 7.8 mmol/L two hours after glucose loading, or diagnosis of diabetes mellitus; (iii) hypertension defined as blood pressure ≥ 130/85 mmHg or diagnosed with hypertension; (iv) fasting triglycerides (TG) ≥ 1.70 mmol/L; and (v) fasting high-density lipoprotein cholesterol (HDL-C) \\< 1.04 mmol/L.\n2. Patients were aged 25 to 65 years, with no restrictions on number of males or females.\n3. Patients exhibited a long-term sedentary lifestyle and did not carry out moderate-intensity physical activity for at least three d/week of 30 min/d duration within three months of the study.\n4. Patients were willing to participate and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients in an acute phase of various diseases or with organ failure, tumor, myocardial infarction, cardiac insufficiency, myocarditis, or chronic lung disease;\n2. Patients with long-term alcohol consumption and those unable to ensure regular lifestyle habits during the intervention period;\n3. Patients who were unable to ensure that they would carry out the stipulated exercise protocol during the intervention; and\n4. Patients with drug modifications during the intervention that could affect the outcome markers.'}, 'identificationModule': {'nctId': 'NCT06379204', 'briefTitle': 'A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test', 'organization': {'class': 'OTHER', 'fullName': 'Taiyuan Central Hospital of Shanxi Medical University'}, 'officialTitle': 'A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test', 'orgStudyIdInfo': {'id': 'No.2022026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the maximum physiological value standardized group', 'interventionNames': ['Behavioral: the maximum physiological value standardized group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the ventilatory threshold individualized group', 'interventionNames': ['Behavioral: the ventilatory threshold individualized group']}], 'interventions': [{'name': 'the maximum physiological value standardized group', 'type': 'BEHAVIORAL', 'description': '10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and HRR heart rate reserve method, gradually increasing.', 'armGroupLabels': ['the maximum physiological value standardized group']}, {'name': 'the ventilatory threshold individualized group', 'type': 'BEHAVIORAL', 'description': '10 kcal/kg/week for 1-6 weeks, 12.5 kcal/kg/week for 7-12 weeks, exercise frequency of 3d/week, exercise intensity calculated by CPET measurement and three zone threshold model, gradually increasing.', 'armGroupLabels': ['the ventilatory threshold individualized group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030009', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Taiyuan Cardiac Rehabilitation Center', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiyuan Central Hospital of Shanxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Therapist', 'investigatorFullName': 'Liu Ruojiang', 'investigatorAffiliation': 'Taiyuan Central Hospital of Shanxi Medical University'}}}}