Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT01310335
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2011-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Whole-Body Vibration on Plasma Sclerostin Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'C537525', 'term': 'Sclerosteosis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-07', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Sclerostin Level', 'timeFrame': '1 month', 'description': 'Change of plasma sclerostin level with whole-body vibration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sclerostin', 'whole-body vibration'], 'conditions': ['Osteopenia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.\n\nFifteen healthy young adult women are planned to include in this study. All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period. Training duration will be short at the beginning but progressed slowly.\n\nThe amplitude of vibration will be 2 mm and the frequency of the vibration will be 40 Hz. The subjects will be asked to report negative side effects or adverse reactions in their training diary.\n\nPrevibration and postvibration (just after, 10.minute and 30.minute) levels of plasma sclerostin will be measured on first, second and fifth day of experiment. Sclerostin levels will be measured by human sclerostin ELISA kit.', 'detailedDescription': 'Whole-body vibration has a strong osteogenic effect. The cyclic mechanical loading to the bone stimulates the osteocytes.\n\nSclerostin, the protein product of the SOST gene, is an osteocyte-specific cysteine knot-secreted glycoprotein that is a potent inhibitor of bone formation. Sost/sclerostin levels have been reported to be reduced by mechanical stimulation.\n\nThe aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy women,\n* Women with ages varying between 20 and 40 years\n* Right-handed women\n\nExclusion Criteria:\n\n* Lower extremity problems\n\n 1. Orthopedic problems: shortness of legs, congenital anomalies, etc.\n 2. Joint disease (arthritis, joint prosthesis, etc.)\n 3. Other painful pathologies in the lower extremities (fractures, tendinitis,bursitis, etc.)\n 4. Circulation problems in the lower extremities\n* Dorsolumbar diseases: Vertebral fract, disc hernias, spondylodiskitis, etc.\n* Systemic disease cases\n\n 1. Systemic bone disease: osteoporosis, osteomalacia, Paget's disease\n 2. Hypertension (\\>135 mmHg systolic, \\>85 mmHg diastolic)\n 3. Heart dis.(coronary dis, conduction/rhythm prob, cardiac pacemaker)\n 4. Infectious diseases\n 5. Endocrine diseases (Diabetes mellitus etc)\n* Neurological diseases (CNS problems, peripheral neuropathy)\n* Menstrual cycle disorders, amenorrhea, lactation, oral contraceptive use\n* Cases during the ovulatory period (11-16th day of menses)\n* Obesity (BMI \\>30 kg/m2) or low BMI (BMI \\<20 kg/m2)\n* Vertigo\n* Cognitive function disorders\n* Women whose blood samples were not taken in the time planned\n* Women whose blood samples hemolyzed"}, 'identificationModule': {'nctId': 'NCT01310335', 'acronym': 'WBV-SCL', 'briefTitle': 'Effect of Whole-Body Vibration on Plasma Sclerostin Level', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bagcilar Training and Research Hospital'}, 'officialTitle': 'Effect of Whole-Body Vibration on Plasma Sclerostin Level in Healthy Young Adult Women', 'orgStudyIdInfo': {'id': 'BEAH FTR-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training', 'description': 'The whole-body vibration (WBV) training', 'interventionNames': ['Device: whole-body vibration (WBV)']}], 'interventions': [{'name': 'whole-body vibration (WBV)', 'type': 'DEVICE', 'otherNames': ['Cyclic mechanical loading'], 'description': 'All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period.', 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bagcilar Training & Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'ILHAN KARACAN, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bagcilar Training & Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bagcilar Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Physical Med & Rehab Clinic', 'investigatorFullName': 'Ilhan Karacan, Clinical Associated Professor', 'investigatorAffiliation': 'Bagcilar Training and Research Hospital'}}}}