Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-02 @ 4:04 AM
Study NCT ID:
NCT03688932
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of WBV Associated With IMT on Functionality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2018-09-26', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking Distance', 'timeFrame': 'Change from Baseline walking distance at 3 months', 'description': 'The walking distance will be assessed through the six-minute walk test.'}], 'secondaryOutcomes': [{'measure': 'Balance', 'timeFrame': 'Change from Baseline balance at 3 months', 'description': 'Static balance and dynamic balance will be evaluated through the Tinetti test'}, {'measure': 'Functionality', 'timeFrame': 'Change from Baseline functionality at 3 months', 'description': 'It will be evaluated through the Timed Up and Go (TUG) test.'}, {'measure': 'Hand grip strength', 'timeFrame': 'Change from Baseline hand grip strength at 3 months', 'description': 'The strength of the dominant hand will be evaluated by dynamometry.'}, {'measure': 'Muscle Metabolism', 'timeFrame': 'Change from Baseline muscle metabolism at 3 months', 'description': 'It will be assessed through the blood lactate and glucose rate after moderate physical activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aging', 'functional capacity', 'muscle metabolism'], 'conditions': ['Frail Elderly Syndrome']}, 'descriptionModule': {'briefSummary': 'The pre-frail elderly are a population more vulnerable to diminished functionality and future disabilities. Thus, interventions focused on the prevention of sarcopenia are indicated to prevent dysfunction in this population. This study aims to evaluate the effects of whole body vibration training associated with inspiratory muscle training on functional outcomes, balance and muscle metabolism in pre-frail elderly women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To able to walk without assistance\n* Good understanding to carry out the proposed tests, evaluated through the Mini Mental State Examination (MMSE).\n\nExclusion Criteria:\n\n* Contraindication or difficulty to perform evaluation procedures\n* Users of medications that interfere with the cardiovascular and / or muscular system\n* Smokers\n* Neuromuscular or degenerative diseases\n* Pulmonary comorbidities\n* Heart diseases and labyrinthitis'}, 'identificationModule': {'nctId': 'NCT03688932', 'briefTitle': 'Effects of WBV Associated With IMT on Functionality', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': 'Effects of Whole Body Vibration Associated With the Inspiratory Muscle Training Program on Functional Capacity, Balance and Muscle Metabolism', 'orgStudyIdInfo': {'id': 'WBV on Functionality'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WBV + IMT', 'description': 'Whole body vibration training associated with respiratory muscle training (WBV + IMT)', 'interventionNames': ['Other: WBV + IMT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WBV + IMTsham', 'description': 'Whole body vibration training associated with respiratory muscle training sham (WBV + IMTsham)', 'interventionNames': ['Other: WBV + IMTsham']}, {'type': 'SHAM_COMPARATOR', 'label': 'WBVsham + IMTsham', 'description': 'Whole body vibration training sham associated with respiratory muscle training sham (WBVsham + IMTsham)', 'interventionNames': ['Other: WBVsham + IMTsham']}], 'interventions': [{'name': 'WBV + IMT', 'type': 'OTHER', 'description': 'The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training will be performed through a device that provides inspiratory resistance.', 'armGroupLabels': ['WBV + IMT']}, {'name': 'WBV + IMTsham', 'type': 'OTHER', 'description': 'The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training sham will be performed through a device without inspiratory resistance.', 'armGroupLabels': ['WBV + IMTsham']}, {'name': 'WBVsham + IMTsham', 'type': 'OTHER', 'description': 'Whole body vibration training will be performed through a vibrating platform coupled to a device that generates non-therapeutic low frequency vibration. The simulation of inspiratory muscle training will be performed through a device with no inspiratory resistance.', 'armGroupLabels': ['WBVsham + IMTsham']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Federal University of Pernambuco', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Msc', 'investigatorFullName': 'Helga Cecília Muniz de Souza', 'investigatorAffiliation': 'Universidade Federal de Pernambuco'}}}}