Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT03254251
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2017-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Stair Climbing on Arterial Stiffness, Blood Pressure and Leg Strength in Stage-1 Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072799', 'term': 'Stair Climbing'}], 'ancestors': [{'id': 'D016138', 'term': 'Walking'}, {'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2017-08-16', 'studyFirstSubmitQcDate': '2017-08-16', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial stiffness', 'timeFrame': '12 weeks', 'description': 'Arterial stiff ness was measured by brachial to ankle pulse wave velocity (baPWV, m/s) using volume plethysmographic device (VP-1000).'}, {'measure': 'Blood pressure (BP)', 'timeFrame': '12 weeks', 'description': 'BP (mmHg) was measured by volume plethysmographic device. Diastolic blood pressure and systolic blood pressure were measured.'}, {'measure': 'Muscle strength', 'timeFrame': '12 weeks', 'description': 'Muscle strength was measured by the eight repetition maximum (8RM) test using extension machine (Cyber 6000).'}, {'measure': 'Body composition', 'timeFrame': '12 weeks', 'description': 'Body composition was measured using eight-polar tactile-electrode impedance meter (InBody 720). Body weight (kg), fat mass (kg), and fat free mass (kg) were assessed.'}, {'measure': 'Height', 'timeFrame': '12 weeks', 'description': 'Height (m) was measured with a stadiometer'}, {'measure': 'Heart rate (HR)', 'timeFrame': '12 weeks', 'description': 'Heart rate was measured by ECG'}, {'measure': 'Body mass index (BMI)', 'timeFrame': '12 weeks', 'description': 'BMI was calculated as weight/height\\^2 (kg/m\\^2)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Menopause']}, 'referencesModule': {'references': [{'pmid': '29438269', 'type': 'DERIVED', 'citation': 'Wong A, Figueroa A, Son WM, Chernykh O, Park SY. The effects of stair climbing on arterial stiffness, blood pressure, and leg strength in postmenopausal women with stage 2 hypertension. Menopause. 2018 Jul;25(7):731-737. doi: 10.1097/GME.0000000000001072.'}]}, 'descriptionModule': {'briefSummary': 'We used a parallel experimental design. Following an initial screening and familiarization session of study tests and procedures, eligible postmenopausal women were randomly assigned to a stair climbing (SC) group or non-exercising control group. SC training session was progressive program, and was performed 4 days a week for 12 weeks. Measurements were collected at baseline and after 12 weeks during the same time of day (±1 hour) in the morning following an overnight fast and abstinence from caffeinated drinks, alcohol, and between 48 and 72 hours after the last exercise session.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '58 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage-1 hypertension\n* Postmenopausal\n\nExclusion Criteria:\n\n* Pulmonary, renal, adrenal, pituitary, severe psychiatric, thyroid, or cardiovascular disease other than stage-1 systolic hypertension (140-159 mmHg)\n* Hormone replacement therapy during the 6 months prior the study\n* Smoker or having any medication changes in the previous year\n* Experience with psychological and physical therapy in the previous year\n* History of steady exercise or exercise training in the last year'}, 'identificationModule': {'nctId': 'NCT03254251', 'briefTitle': 'The Effects of Stair Climbing on Arterial Stiffness, Blood Pressure and Leg Strength in Stage-1 Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University'}, 'officialTitle': 'The Effects of a 12-week Stair Climbing Regimen on Arterial Stiffness, BP and Leg Strength in Stage-1 Hypertensive Postmenopausal Women', 'orgStudyIdInfo': {'id': 'PusanNU-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stair Climbing (SC)', 'description': 'N=20, 12 weeks of stair climbing exercise training.', 'interventionNames': ['Behavioral: Stair climbing']}, {'type': 'NO_INTERVENTION', 'label': 'No Exercise (CON)', 'description': 'N=21, No exercise for 12 weeks'}], 'interventions': [{'name': 'Stair climbing', 'type': 'BEHAVIORAL', 'description': 'Stair climbing (SC) training was 12 weeks of progressive SC program. Each training session consisted of a general warm-up (5 min: slow and fast skipping, stretching) followed by the SC training and was supervised by experienced personnel. The program began with two bouts of stair climbing four days a week in weeks 1 and 2, increasing by one climb a day every three weeks. By the last three weeks (10-12) of the study, all subjects were completing 5 climbs four days a week. During each climb participants ascended 12 flights (192 steps) divided into 3 sets of 4 flights, with a 2 min rest period between each set. There was a 5 min rest period between climbs that allowed the participants to reach the ground floor using an elevator. Subjects in the non-exercising control group did not participate in a supervised exercise program for the duration of the study.', 'armGroupLabels': ['Stair Climbing (SC)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dong-Eui University', 'class': 'OTHER'}, {'name': 'University of Nebraska', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'postdoctoral fellow', 'investigatorFullName': 'Won-mok son', 'investigatorAffiliation': 'Pusan National University'}}}}