Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT02268292
Status:
COMPLETED
Last Update Posted:
2014-10-20
First Post:
2014-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Bicycle Exercise and Aerobic Capacity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-15', 'studyFirstSubmitDate': '2014-09-27', 'studyFirstSubmitQcDate': '2014-10-15', 'lastUpdatePostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic syndrome', 'timeFrame': '12 weeks', 'description': 'Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '12 weeks', 'description': 'A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects'}, {'measure': 'Brain-derived neurotrophic factor', 'timeFrame': '12 weeks', 'description': 'Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R\\&D Systems, Minneapolis, U.S.A.)'}, {'measure': 'Arterial stiffness', 'timeFrame': '12 weeks', 'description': 'Pulse wave velocity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic syndrome', 'Diabetes', 'Muscle strength', 'Aerobic exercise', 'Bicycle', 'Brain-derived neurotrophic factor'], 'conditions': ['Metabolic Cardiovascular Syndrome']}, 'referencesModule': {'references': [{'pmid': '25682570', 'type': 'DERIVED', 'citation': 'Tsai SW, Chan YC, Liang F, Hsu CY, Lee IT. Brain-derived neurotrophic factor correlated with muscle strength in subjects undergoing stationary bicycle exercise training. J Diabetes Complications. 2015 Apr;29(3):367-71. doi: 10.1016/j.jdiacomp.2015.01.014. Epub 2015 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program. All participators underwent an indoor bicycle exercise for twelve weeks. In addition to demographic data and biochemical tests were determined after an overnight fasting. Extension of muscle strength was detected in the dominant lower extremity.', 'detailedDescription': 'This prospective open-labeled study was conducted in Taichung Veterans General Hospital. The adult participants with metabolic syndrome and/or type 2 diabetes were enrolled. MetS. The procedures were fully explained to all subjects before the cardiopulmonary exercise test. ll enrolled subjects received a scheduled twelve-week program for exercise-training program. A commercially available bicycle with an indoor bicycle trainer are used as the home exercise training modality. All medications were not allowed to be changed during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult with metabolic syndrome or type 2 diabetes\n\nExclusion Criteria:\n\n* hyperglycemic crisis or HbA1c \\> 12%;\n* serum creatinine levels greater than 200 mmol/L;\n* acute or chronic infectious diseases;\n* limitations in the ability to undertake regular exercise'}, 'identificationModule': {'nctId': 'NCT02268292', 'briefTitle': 'Home Bicycle Exercise and Aerobic Capacity', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'The Effects of Home Bicycle Exercise Program on Hyperlipidemia, Hypertension, Blood Sugar Control, Muscle Strength and Aerobic Capacity', 'orgStudyIdInfo': {'id': 'SG12147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bicycle Exercise', 'description': 'Bicycle Exercise for 12 weeks', 'interventionNames': ['Behavioral: bicycle exercise']}], 'interventions': [{'name': 'bicycle exercise', 'type': 'BEHAVIORAL', 'description': 'All enrolled subjects received a scheduled twelve-week exercise program. A commercially available bicycle (Giant CS800, Taichung, Taiwan) with an indoor bicycle stand (Giant Cyclotron Mag, Taichung, Taiwan) was used as the home exercise training modality.', 'armGroupLabels': ['Bicycle Exercise']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Taichung Veterans General Hospital', 'investigatorFullName': 'TCVGH', 'investigatorAffiliation': 'Taichung Veterans General Hospital'}}}}