Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 10:36 PM
Study NCT ID:
NCT01259661
Status:
UNKNOWN
Last Update Posted:
2010-12-14
First Post:
2010-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity and Metabolic Risk Factors in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-12', 'studyFirstSubmitDate': '2010-12-07', 'studyFirstSubmitQcDate': '2010-12-12', 'lastUpdatePostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Postmenopausal women's daily energy expenditure", 'timeFrame': '12 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical activity', 'metabolic syndrome', 'postmenopausal women', 'exercise training'], 'conditions': ['Postmenopausal Women']}, 'descriptionModule': {'briefSummary': 'Hormonal changes associated with menopause, chronological aging, and lifestyle, especially physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women. Women exhibiting "the metabolic syndrome" have multiple coronary artery disease risk factors, including insulin resistance, hyperlipidemia, and hypertension. This study will be conducted to test the hypotheses: (1) physical activity and physical fitness levels may have effects on individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance exercise training may have a favorable effect on components of the metabolic risk variables in these women.\n\nIn this study, the associations among physical activity (including daily energy expenditure and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level, and metabolic risk profile of the women will be assessed. The investigators will perform a randomized trial to compare the effects of moderate-intensity aerobic exercise training regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk factor for metabolic syndrome will be randomized in the exercise group or control groups. Metabolic risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure, lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study. Differences from baseline to follow-up will be calculated and compared across groups.\n\nResults of this study may help health care providers providing advice to postmenopausal women for life style changes to reduce risk of insulin resistance, coronary heart disease, and diabetes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have one or more metabolic risk variables as defined by the ATP III (2001)\n* age between 35 and 64 years\n* absence of known heart disease\n* resting BP: 130 \\< SBP \\< 160 and 85 \\< DBP \\< 100\n* currently physical inactive (\\< 30 min of physical activity per week)\n\nExclusion Criteria:\n\n* None of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.'}, 'identificationModule': {'nctId': 'NCT01259661', 'briefTitle': 'Physical Activity and Metabolic Risk Factors in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'Physical Activity and Metabolic Risk Factors in Postmenopausal Women', 'orgStudyIdInfo': {'id': '99070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'interventionNames': ['Other: A longitudinal intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: A longitudinal intervention']}], 'interventions': [{'name': 'A longitudinal intervention', 'type': 'OTHER', 'description': "In our longitudinal intervention study, all eligible subjects will undergo a physical examination by a physician to rule out obvious secondary causes of hypertension and contraindications to exercise. Randomization will be performed by random member generation. The exercise participants will attend three sessions per week at the facility during the study period. Training intensity is initially set at heart rate equivalent to 60% and progress to 80% of each subject's maximal heart rate reserve for 30 min/day with a frequency of 3 days/wk. Facility-based exercise sessions will consist of treadmill walking.", 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jen-Chen Tsai', 'role': 'CONTACT', 'email': 'jenchent@tmu.edu.tw', 'phone': '886-2-27361661', 'phoneExt': '6308'}], 'facility': 'Taipei Medical University WanFang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jen-Chen Tsai', 'role': 'CONTACT', 'email': 'jenchent@tmu.edu.tw', 'phone': '886-2-27361661', 'phoneExt': '6308'}], 'overallOfficials': [{'name': 'Jen-Chen Tsai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jen-Chen Tsai', 'oldOrganization': 'School of Nursing, Taipei Medical University'}}}}