Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-01 @ 5:27 AM
Study NCT ID:
NCT06454032
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 12-week FW Programme on Sex Hormone Levels and Risk Factors for MS 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure (SBP)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of SBP before and after intervention'}, {'measure': 'Diastolic blood pressure (DBP)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of DBP before and after intervention'}, {'measure': 'Waist circumference (WC)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of WC before and after intervention'}, {'measure': 'Fasting blood glucose (FBG)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of FBG before and after intervention'}, {'measure': 'Triglycerides (TG)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of TG before and after intervention'}, {'measure': 'High-density lipoprotein cholesterol (HDL-C)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of HDL-C before and after intervention'}], 'secondaryOutcomes': [{'measure': 'Oestradiol (E2)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of E2 before and after intervention'}, {'measure': 'Testosterone (T)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of T before and after intervention'}, {'measure': 'Sex hormone-binding globulin (SHBG)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of SHBG before and after intervention'}, {'measure': 'Dehydroepiandrosterone sulphate (DHEA-S)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of DHEA-S before and after intervention'}, {'measure': 'Maximal oxygen uptake (VO2max)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of VO2max before and after intervention'}, {'measure': 'Body weight (BW)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of BW before and after intervention'}, {'measure': 'Height', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of height before and after intervention'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'At the beginning-at 12 weeks.', 'description': 'The change of BMI before and after intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Postmenopause', "Women's health", 'Metabolism', 'Sex hormone'], 'conditions': ['Postmenopause Women']}, 'descriptionModule': {'briefSummary': 'Postmenopausal women were separated into two groups: one participating in a 12-week fitness walking programe as the fitness walking group, and the other maintaining their regular lifestyle as the control group. The study evaluated alterations in health markers and examined the correlation between metabolic syndrome risk factors and sex hormone levels before and after the intervention.', 'detailedDescription': 'According to the inclusion and exclusion criteria, our study invlved postmenopausal women aged from 50 to 69 years old. After the selection process, baseline assessments were conducted, including evaluations of metabolic syndrome risk factors, body morphology measurements, sex hormone levels, and cardiopulmonary exercise testing. Participants were then randomly assigned to either the fitness walking group or the control group using a random number table. Participants in the fitness walking group completed a 12-week fitness walking program, while those in the control group maintained their usual lifestyle without any intervention. During the post-intervention assessment, all baseline measurements were repeated to evaluate changes in the previously measured indicators.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Participants were entirely voluntary and capable of completing the full 12-week intervention process.\n* (2) Participants were postmenopausal women aged between 50 and 69 years.\n* (3) Participants had been postmenopausal for over 12 months and had not received exogenous estrogen supplementation post-menopause.\n\nExclusion Criteria:\n\n* (1) Participants had a history of acute or chronic musculoskeletal disorders, cardiovascular diseases, diabetes, or other conditions that might impact their ability to engage in the intervention.\n* (2) Participants had recent hormone treatment, anti-inflammatory medication use, or other medications affecting blood indices.\n* (3) Participants experienced unstable body weight (fluctuations exceeding 2.5 kg) in the past three months.\n* (4) Participants were concurrently enrolled in other intervention studies or maintained regular exercise routines.\n* (5) Participants had smoking or alcohol consumption habits.'}, 'identificationModule': {'nctId': 'NCT06454032', 'briefTitle': 'Effect of 12-week FW Programme on Sex Hormone Levels and Risk Factors for MS in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Sport University'}, 'officialTitle': 'Effect of 12-week Fitness Walking Programme on Sex Hormone Levels and Risk Factors for Metabolic Syndrome in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'EOFWOSHLARFMSIPP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fitness walking group', 'interventionNames': ['Behavioral: Fitness walking']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Behavioral: Maintained lifestyle']}], 'interventions': [{'name': 'Fitness walking', 'type': 'BEHAVIORAL', 'description': 'Fitness walking for 12 weeks.', 'armGroupLabels': ['Fitness walking group']}, {'name': 'Maintained lifestyle', 'type': 'BEHAVIORAL', 'description': 'Maintained their normal lifestyle, without exercise intervention.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'School of Sports Medicine and Rehabilitation, Beijing Sport University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'School of Sports Medicine and Rehabilitation', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Sport University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}