Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-12 @ 1:56 PM
Study NCT ID:
NCT03865368
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive People With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcomes assessor was blinded.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Active Whole Body Vibration (aWBVT) group, performed ten dynamic standard exercises on a vibration platform. The vibration protocol lasted for 15 minutes, in a frequency of 30 Hz and amplitude of 2 mm. Control group performed only ten dynamic standard exercises with no vibration application. Blood Pressure, heart rate, saturated oxygen were measured for the hemodynamic response. Modified Borg Dyspnoea Scale (MBDS) and The Borg Rating of Perceived Exertion (BRPE) Scale were used in order to evaluate fatigue level. All evaluations were performed at the beginning of the study, at the end of the session and at the recovery period'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Dyspnea', 'timeFrame': '"20 minute"', 'description': 'Modified Borg Dyspnea Scale Minimum score 0: breathing is causing no difficulty Maximum score 10: breathing difficulty is maximal'}], 'primaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '"20 minute"', 'description': 'Heart rate was evaluated from the brachial artery using a sphygmanometer.'}, {'measure': 'Blood pressure', 'timeFrame': '"20 minute"', 'description': 'Blood pressure was evaluated using a sphygmomanometer.'}], 'secondaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': '"20 minute"', 'description': "Borg's Rating of Perceived Exertion Scale. Minimum score: 6 Maximum score: 20 The Borg Rating of Perceived Exertion scale helps estimate activity intensity."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Blood Pressure', 'Whole Body Vibration', 'Exercise']}, 'descriptionModule': {'briefSummary': 'Whole Body Vibration Therapy (WBVT) has been identified as a useful tool to increase peripheral blood flow. The present study aimed at how dynamic exercises with WBVT immediate effect on hemodynamic response and fatigue parameters in patients with obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals between age 18-65 with Body Mass Index (BMI) of \\>29.9 kg/m2\n\nExclusion Criteria:\n\n* Unstable hypertensive patients\n* History of cardiovascular, neurologic, or orthopedic diseases,\n* Presence of knee prosthesis, hip replacement\n* Chronic inflammatory disease,\n* Anti-inflammatory treatment\n* Cognitive impairments\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT03865368', 'acronym': 'RT', 'briefTitle': 'Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive People With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Okan University'}, 'officialTitle': 'Immediate Effects of Whole Body Vibration on Hemodynamic Response and Fatigue in Normotensive Patients With Obesity', 'orgStudyIdInfo': {'id': 'Okan_University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Whole Body Vibration Training', 'description': 'Exercises were taught during the first session, active training was done in the second session, and acute evaluations were made during the third session. Both groups performed the dynamic exercises, under supervision, on the whole body vibration device with 10-second rest intervals. Throughout the WBVT session, the vibration amplitude was set to 2 mm and exercise frequency 30 Hz.', 'interventionNames': ['Other: Whole Body Vibration Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The same exercises as the aWBVT group were performed on the vibration platform, with the vibration application turned off', 'interventionNames': ['Other: Whole Body Vibration Training']}], 'interventions': [{'name': 'Whole Body Vibration Training', 'type': 'OTHER', 'otherNames': ['Standard Exercise'], 'description': 'Whole Body Vibration Training (WBVT) method has been used as an alternative to conventional strengthening exercises. In this method, the patient stands on the platform of the WBVT device in a static position or performs dynamic exercises, the mechanical vibration produced by the device is transferred to the body', 'armGroupLabels': ['Active Whole Body Vibration Training', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34959', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Okan University Sports Laboratory', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medipol University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tülay Çevik', 'investigatorAffiliation': 'Okan University'}}}}