Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT03941067
Status:
UNKNOWN
Last Update Posted:
2019-05-07
First Post:
2019-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Pre-event Massage Over the Neuromuscular Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-06-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2019-05-03', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delay time change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).'}, {'measure': 'Contraction time change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).'}, {'measure': 'Sustain time change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).'}, {'measure': 'Relaxation time change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).'}, {'measure': 'Maximal displacement change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).'}], 'secondaryOutcomes': [{'measure': 'Gastrocnemious strength change', 'timeFrame': '8 minutes before the intervention, and 2 minutes after the intervention', 'description': 'Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).'}, {'measure': 'Passive ankle dorsiflexion change', 'timeFrame': '6 minutes before the intervention, and 4 minutes after the intervention', 'description': 'Passive range of motion of the ankle dorsiflexion, using an inclinometer (degrees).'}, {'measure': 'Jump height change', 'timeFrame': '10 minutes before the intervention, and 1 minute after the intervention', 'description': 'Maximum jump height with one leg using the application "My Jump 2" (centimeters).'}, {'measure': 'Stiffness change', 'timeFrame': '5 minute before the intervention, and 5 minute after the intervention', 'description': 'Resistance to an external force that deforms its initial shape, using a "Myoton".'}, {'measure': 'Elasticity change', 'timeFrame': '5 minute before the intervention, and 5 minute after the intervention', 'description': 'Capacity to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton".'}, {'measure': 'Relaxation change', 'timeFrame': '5 minute before the intervention, and 5 minute after the intervention', 'description': 'Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton" (miliseconds).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromuscular response', 'pre-competition massage', 'pre-event massage'], 'conditions': ['Neuromuscular Diseases']}, 'referencesModule': {'references': [{'pmid': '33917668', 'type': 'DERIVED', 'citation': 'Perez-Bellmunt A, Labata-Lezaun N, Llurda-Almuzara L, Rodriguez-Sanz J, Gonzalez-Rueda V, Bueno-Gracia E, Celik D, Lopez-de-Celis C. Effects of a Massage Protocol in Tensiomyographic and Myotonometric Proprieties. Int J Environ Res Public Health. 2021 Apr 8;18(8):3891. doi: 10.3390/ijerph18083891.'}]}, 'descriptionModule': {'briefSummary': 'The study observes the effect of a pre-event massage on the gastrocnemius muscles over the neuromuscular response of the gastrocnemious muscles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Exclusion Criteria:\n\n* Muscle injury in the last two months\n* To not understand the study orders\n* Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol"}, 'identificationModule': {'nctId': 'NCT03941067', 'briefTitle': 'Effects of Pre-event Massage Over the Neuromuscular Response', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'officialTitle': 'Effects of Pre-event Massage Over the Neuromuscular Response of Gastrocnemius Muscles', 'orgStudyIdInfo': {'id': 'Protocol 4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-event massage', 'interventionNames': ['Other: Pre-event massage']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Pre-event massage', 'type': 'OTHER', 'description': 'Five minutes massage, combining superficial and high-frequency techniques of massage applied with the therapist hands', 'armGroupLabels': ['Pre-event massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08195', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Universitat Internacional de Catalunya', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}], 'overallOfficials': [{'name': 'Albert Pérez-Bellmunt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat Internacional de Catalunya'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Albert Pérez Bellmunt', 'investigatorAffiliation': 'Universitat Internacional de Catalunya'}}}}