Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT02090192
Status:
UNKNOWN
Last Update Posted:
2014-03-18
First Post:
2014-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Whole-body Vibration in the Frail Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-16', 'studyFirstSubmitDate': '2014-03-14', 'studyFirstSubmitQcDate': '2014-03-16', 'lastUpdatePostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change of the common femoral artery's blood flow from Baseline to 60min post-WBV", 'timeFrame': '60min post-WBV'}, {'measure': 'Change of lower extremities muscle strength from Baseline to 3 month post-WBV', 'timeFrame': '3 month post-WBV'}, {'measure': 'Change of "timed up and go" test (TUGT) from Baseline to 3 month post-WBV', 'timeFrame': '3 month post-WBV'}, {'measure': 'Change of 30-second chair stand test from Baseline to 3 month post-WBV', 'timeFrame': '3 month post-WBV'}, {'measure': 'Change of balance function from Baseline to 3 month post-WBV', 'timeFrame': '3 month post-WBV'}, {'measure': 'Change of balance confidence from Baseline to 3 month post-WBV', 'timeFrame': '3 month post-WBV'}, {'measure': 'Change of bone density from Baseline to 6 month post-WBV', 'timeFrame': '6 month post-WBV'}, {'measure': 'Change of general health status (SF-12 score) from Baseline to 6 month post-WBV', 'timeFrame': '6 month post-WBV'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Whole-body vibration;', 'Frail Elderly;', 'Blood flow;', 'Bone density', 'Mobility;', 'Balance;', 'Muscle strength;', 'Lower Extremity;', 'Musculoskeletal System;', 'Health Status;', 'Exercise;', 'Mechanical Oscillation'], 'conditions': ['Sarcopenia;', 'Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status, and its feasibility as an intervention in frail elderly patients.\n\nDesign: Randomized controlled trial. Subjects: The frail older persons meeting the Fried Frailty Criteria.\n\nInterventions: All eligible subjects were randomly assigned to 4 groups:\n\n(1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+ PRT group: Subjects received the whole-body vibration and progressive resistance training; (4) Control group: Subjects received no intervention/training. The periods of intervention are 12 weeks.\n\nMain measures: The lower extremities blood flow (the diameters and red blood cell velocity of the common femoral artery), timed up and go test, 30-second chair stand test, five times sit to stand test, lower extremities muscle strength, balance function, balance confidence, bone density, and general health status was assessed at the beginning of the study, at instant, 12 weeks and 24 month after the intervention.\n\nStudy hypothesis: Whole-body vibration exercise is a safe and effective method that can improve the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status in the frail elderly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥75 years old\n* Fried Frailty Criteria\n* Mini Mental State Examination score ≥18\n\nExclusion Criteria:\n\n* Recent fractures (≤6 months)\n* Gallbladder or kidney stones\n* Malignancies\n* Rheumatic arthritis\n* Epilepsy\n* Serious heart sicknesses or an implant, and bypass stent or cardiac pacemaker\n* Any diseases to be associated with a life expectancy of less than 12 months'}, 'identificationModule': {'nctId': 'NCT02090192', 'briefTitle': 'Effects of Whole-body Vibration in the Frail Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Acute and Chronic Effects of Whole-body Vibration on Mobility, Muscle Strength, Bone and General Health Status in the Frail Elderly', 'orgStudyIdInfo': {'id': 'ChinaPLAGH-2013FC3009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WBV training', 'description': 'Whole-body vibration training was performed on a commercial Galileo machine (Germany). Participants were required to stand on the moveable rectangular platform and positioned their feet at an equal and standardized distance from the axis of rotation so that the vertical vibration amplitude was 1-3 mm. The frequency was set at 6-26 Hz. The vibration protocol consisted of four to five bouts (60 seconds for each bout), and three to five times a week for 12 weeks. The positions taken by the subjects differed according to their function. Participants who could stand independently were instructed to adopt a "partial squat" position with slight flexion at the hips, knees, and ankle joints to damp the vibrations approximately at the pelvic level.', 'interventionNames': ['Procedure: WBV training']}, {'type': 'EXPERIMENTAL', 'label': 'WBV+ PRT training', 'interventionNames': ['Procedure: WBV training', 'Procedure: PRT training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PRT training', 'interventionNames': ['Procedure: PRT training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group'}], 'interventions': [{'name': 'WBV training', 'type': 'PROCEDURE', 'armGroupLabels': ['WBV training', 'WBV+ PRT training']}, {'name': 'PRT training', 'type': 'PROCEDURE', 'armGroupLabels': ['PRT training', 'WBV+ PRT training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunhua Li, Bachelor', 'role': 'CONTACT', 'email': '18601224462@163.com', 'phone': '8610-66875462'}], 'facility': 'Rehabilitation Department, Nanlou, Chinese PLA general hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Li Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhangli781230@163.com', 'phone': '8610-66876335'}], 'overallOfficials': [{'name': 'Changshui Weng, Bachelor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Li Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Li Zhang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}