Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT04930068
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'closed enveloped'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group (A) consisted of 25 females who treated by ultrasonic cavitation, group (B) consisted of 25 females who performed aerobic exercise.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-10', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioelectrical impedance analysis', 'timeFrame': '6 weeks', 'description': 'was used to estimate body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Most body water is stored in muscle in both groups A and B'}], 'secondaryOutcomes': [{'measure': 'skin fold caliper', 'timeFrame': '6 weeks', 'description': 'was used to measure the waist circumference and amount of subcutaneous fat when the fold for all females in both groups (A\\&B)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonic', 'aerobic exercise', 'Diet'], 'conditions': ['Ultrasonic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the effect of ultrasonic cavitation on abdominal obesity in females. Fifty volunteer females with abdominal obesity participated in the study.', 'detailedDescription': 'The purpose of this study was to determine the effectiveness of ultrasonic cavitation on abdominal obesity in adolescent females. Fifty volunteer females with abdominal obesity participated in the study.\n\nGroup (A) consisted of 25 females who treated by ultrasonic cavitation on abdominal region for 30 minutes and aerobic exercises for 30 minutes, 2 times per week for 6 weeks ; group (B) consisted of 25 females who performed aerobic exercise and low caloric diet.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their ages were range from 17 to 21 years old.\n* Their body mass index less than 35kg/m2.\n\nExclusion Criteria:\n\n* Females with BMI exceed 35kg/m2.\n* Females have psychological disorders.\n* cardiac diseases.\n* hypertension'}, 'identificationModule': {'nctId': 'NCT04930068', 'briefTitle': 'Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females', 'orgStudyIdInfo': {'id': 'Cairo Un112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ultra-sound', 'description': 'ultrasonic cavitation applied on abdominal region for 30 minutes, 2 times per week for 6 weeks.', 'interventionNames': ['Other: low caloric diet']}, {'type': 'EXPERIMENTAL', 'label': 'aerobic exercise', 'description': 'aerobic exercises through treadmill (60-70% of VO2 max.) for 30 minutes, 2 times per week for 6 weeks', 'interventionNames': ['Other: low caloric diet']}], 'interventions': [{'name': 'low caloric diet', 'type': 'OTHER', 'description': 'A low-calorie diet is a structured eating plan that restricts daily caloric intake, commonly for weight loss. Following a low-calorie diet typically means consuming around 1,200 to 1,500 calories per day, which creates a calorie deficit that can lead to weight loss. A low-calorie diet can be effective, but it requires a lot of discipline to work and be safe.', 'armGroupLabels': ['aerobic exercise', 'ultra-sound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Giza', 'state': 'Dokki', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ghada eb elrefaye, professor', 'role': 'CONTACT', 'email': 'ghada.ibrahim2011@yahoo.com', 'phone': '01005572715', 'phoneExt': '002'}, {'name': 'Ghada E Elrefaye, lecturer', 'role': 'CONTACT', 'email': 'ghadaebrahim2000@gmail.com', 'phone': '+201005572715', 'phoneExt': '02'}], 'facility': 'Faculty of physical therapy- Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Ghada E Elrefaye, professor', 'role': 'CONTACT', 'email': 'ghadaebrahim2000@gmail.com', 'phone': '+201005572715', 'phoneExt': '02'}, {'name': 'Ghada E Elrefaye, lecturer', 'role': 'CONTACT', 'email': 'ghadaebrahim2000@gmail.com', 'phone': '+201005572715', 'phoneExt': '02'}], 'overallOfficials': [{'name': 'Ghada E Elrefaye, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': "Ghada ebrahim El Refaye - Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University, Egypt", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt", 'investigatorFullName': 'Ghada Ebrahim El Refaye', 'investigatorAffiliation': 'Cairo University'}}}}