Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-01 @ 4:35 PM
Study NCT ID:
NCT05991050
Status:
UNKNOWN
Last Update Posted:
2023-08-16
First Post:
2023-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Whole Body Vibration on Blood Pressure in Obese 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-13', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-08-06', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure measurement', 'timeFrame': 'before and after 8 weeks of treatment', 'description': 'The auscultatory method of measuring both systolic and diastolic blood pressure was used with a sphygmomanometer properly calibrated and validated'}], 'secondaryOutcomes': [{'measure': 'Anthropometric measurements', 'timeFrame': 'before and after 8 weeks of treatment', 'description': 'using standardized equipment (Weight and height scale). Height of all participants were measured in standing position without footwear. Body mass index was then calculated'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': "All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.Group B (WBV group):\n\nFor 8 weeks, WBV participants completed 3 supervised training sessions a week.", 'detailedDescription': 'I-Group A (control group):\n\nAll post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual\'s average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.\n\nII-Group B (WBV group):\n\nFor 8 weeks, WBV participants completed 3 supervised training sessions a week. Each participant received an explanation of the WBV device and the treatment protocol. Women stood in upright position and hold on handle bar before switching the WBV device at "on" position.\n\nThe exercises were consisted of dynamic squats starting from upright position into the assigned degree of knee flexion "squats with 90° knee angle, semi-squats with 120° knee angle" and heel elevation (calf-raise), each exercise was performed for 3 sets and each set consisted of 5 repetitions. All dynamic exercises were performed with slow controlled movements and between each set, there was resting period during which women assumed upright standing position for 1 minute. Total duration of the training session was 30 minutes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55 -65 years\n* BMI 30 to 34.99 Kg / m2\n* prehypertension and hypertension stage I\n\nExclusion Criteria:\n\n* systolic blood pressure exceeding 159 mm Hg and diastolic blood pressure exceeding 99 mm Hg,\n* diabetic neuropathy disease,\n* patients with mental or psychological disorders,\n* skin disorders or bleeding disorders, and\n* musculoskeletal disorders that limited WBV.'}, 'identificationModule': {'nctId': 'NCT05991050', 'briefTitle': 'Effect of Whole Body Vibration on Blood Pressure in Obese Postmenopausal Women.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Whole Body Vibration on Blood Pressure in Obese Postmenopausal Women. A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diet regimen group', 'description': "an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.", 'interventionNames': ['Dietary Supplement: energy-restricted diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'whole body vibration group', 'description': 'For 8 weeks, WBV participants completed 3 supervised training sessions a week. The exercises were consisted of dynamic squats starting from upright position into the assigned degree of knee flexion "squats with 90° knee angle, semi-squats with 120° knee angle" and heel elevation (calf-raise), each exercise was performed for 3 sets and each set consisted of 5 repetitions.', 'interventionNames': ['Dietary Supplement: energy-restricted diet', 'Device: Whole body vibration']}], 'interventions': [{'name': 'energy-restricted diet', 'type': 'DIETARY_SUPPLEMENT', 'description': "Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.", 'armGroupLabels': ['Diet regimen group', 'whole body vibration group']}, {'name': 'Whole body vibration', 'type': 'DEVICE', 'description': 'For 8 weeks, WBV participants completed 3 supervised training sessions a week. The exercises were consisted of dynamic squats starting from upright position into the assigned degree of knee flexion "squats with 90° knee angle, semi-squats with 120° knee angle" and heel elevation (calf-raise), each exercise was performed for 3 sets and each set consisted of 5 repetitions.', 'armGroupLabels': ['whole body vibration group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12111', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed M Maged', 'role': 'CONTACT', 'email': 'Ahmedmaged@cu.edu.eg', 'phone': '+201005227404'}, {'name': 'Wafaa Kamal', 'role': 'CONTACT', 'email': 'wafaa_kamal37@yahoo.com', 'phone': '01006914119'}], 'overallOfficials': [{'name': 'Ahmed M Maged', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ahmed M Maged, MD', 'investigatorAffiliation': 'Cairo University'}}}}