Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-01-12 @ 1:53 AM
Study NCT ID:
NCT01398605
Status:
COMPLETED
Last Update Posted:
2011-08-18
First Post:
2011-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-16', 'studyFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mass index (BMI)', 'timeFrame': '3 months'}, {'measure': 'Waist circumference', 'timeFrame': '3 months'}, {'measure': 'Lab data (lipid profile, CRP, insulin resistance)', 'timeFrame': '3 months'}, {'measure': 'QT interval and corrected QT interval (QTc)', 'timeFrame': '3 months'}, {'measure': 'Cardiovascular fitness', 'timeFrame': '3 months'}, {'measure': 'Heart rate recovery after exercise test', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Myocardial perfusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postmenopausal women', 'Physical activity', 'Cardiovascular risks', 'Cardiac function', 'Dose-response'], 'conditions': ['Postmenopausal Disorder']}, 'descriptionModule': {'briefSummary': 'The study is designed to investigate the physical activity and its dose-response relationship in postmenopausal women on the cardiovascular risks and cardiac function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women aged 40 to 80 years and age matched men without major diseases\n\nExclusion Criteria:\n\n* Known cardiac disease, excessive weight change during last year, cancer and mental disorders'}, 'identificationModule': {'nctId': 'NCT01398605', 'briefTitle': 'Physical Activity in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Physical Activity and Exercise Dose-response on Cardiovascular Risk Factors in Postmenopausal Women', 'orgStudyIdInfo': {'id': '200709026R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'moderate exercise training', 'interventionNames': ['Other: Exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'intensive exercise training', 'interventionNames': ['Other: Exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Exercise training', 'type': 'OTHER', 'description': 'Different dose of exercise training', 'armGroupLabels': ['intensive exercise training', 'moderate exercise training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ying-Tai Wu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ying-Tai Wu', 'oldOrganization': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University'}}}}