Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-29 @ 9:15 AM
Study NCT ID:
NCT01391195
Status:
COMPLETED
Last Update Posted:
2011-07-13
First Post:
2011-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Low Level Laser Therapy (808nm) on Muscle Performance of Young Women Submitted to Physical Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-12', 'studyFirstSubmitDate': '2011-07-07', 'studyFirstSubmitQcDate': '2011-07-08', 'lastUpdatePostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Index of knee extensor muscles', 'timeFrame': 'nine weeks', 'description': 'Fatigue Index of knee extensor muscles assessed in isokinetic dynamometry.'}, {'measure': 'Ventilatory threshold', 'timeFrame': 'nine weeks', 'description': 'Ventilatory threshold quantified by a gas analyzer.'}, {'measure': 'VO2max', 'timeFrame': 'nine weeks', 'description': 'VO2max quantified by a gas analyzer.'}, {'measure': 'VO2peak', 'timeFrame': 'nine weeks', 'description': 'VO2peak quantified by a gas analyzer.'}, {'measure': "Maximum load of effort on cycle ergometer (Balke's protocol).", 'timeFrame': 'nine weeks', 'description': 'Maximum load of effort on cycle ergometer quantified in Watts.'}], 'secondaryOutcomes': [{'measure': 'Total work of knee extensor muscles', 'timeFrame': 'nine weeks', 'description': 'Total work of knee extensor muscles assessed in isokinetic dynamometry'}, {'measure': 'Peak torque of knee extensor muscles', 'timeFrame': 'nine weeks', 'description': 'Peak torque of knee extensor muscles assessed in isokinetic dynamometry'}, {'measure': 'Borg scale', 'timeFrame': 'nine weeks', 'description': 'Subjective effort perception assessed by Borg scale'}, {'measure': 'Heart rate', 'timeFrame': 'nine weeks', 'description': 'Heart Rate assessed by cardiac frequency meter'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low level laser therapy', 'muscle performance', 'fatigue index', 'endurance training', 'ventilatory threshold', 'VO2Max', 'VO2Peak'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '21086010', 'type': 'BACKGROUND', 'citation': 'Ferraresi C, de Brito Oliveira T, de Oliveira Zafalon L, de Menezes Reiff RB, Baldissera V, de Andrade Perez SE, Matheucci Junior E, Parizotto NA. Effects of low level laser therapy (808 nm) on physical strength training in humans. Lasers Med Sci. 2011 May;26(3):349-58. doi: 10.1007/s10103-010-0855-0. Epub 2010 Nov 18.'}, {'pmid': '20024577', 'type': 'BACKGROUND', 'citation': 'Leal Junior EC, Lopes-Martins RA, de Almeida P, Ramos L, Iversen VV, Bjordal JM. Effect of low-level laser therapy (GaAs 904 nm) in skeletal muscle fatigue and biochemical markers of muscle damage in rats. Eur J Appl Physiol. 2010 Apr;108(6):1083-8. doi: 10.1007/s00421-009-1321-1. Epub 2009 Dec 19.'}, {'pmid': '16627677', 'type': 'BACKGROUND', 'citation': 'Lopes-Martins RA, Marcos RL, Leonardo PS, Prianti AC Jr, Muscara MN, Aimbire F, Frigo L, Iversen VV, Bjordal JM. Effect of low-level laser (Ga-Al-As 655 nm) on skeletal muscle fatigue induced by electrical stimulation in rats. J Appl Physiol (1985). 2006 Jul;101(1):283-8. doi: 10.1152/japplphysiol.01318.2005. Epub 2006 Apr 20.'}, {'pmid': '20602109', 'type': 'BACKGROUND', 'citation': 'Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3.'}, {'pmid': '20626264', 'type': 'BACKGROUND', 'citation': 'Baroni BM, Leal Junior EC, Geremia JM, Diefenthaeler F, Vaz MA. Effect of light-emitting diodes therapy (LEDT) on knee extensor muscle fatigue. Photomed Laser Surg. 2010 Oct;28(5):653-8. doi: 10.1089/pho.2009.2688. Epub 2010 Jul 13.'}, {'pmid': '19057981', 'type': 'BACKGROUND', 'citation': 'Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Taufer D, Manfro DS, Rech M, Danna V, Grosselli D, Generosi RA, Marcos RL, Ramos L, Bjordal JM. Effect of 830 nm low-level laser therapy applied before high-intensity exercises on skeletal muscle recovery in athletes. Lasers Med Sci. 2009 Nov;24(6):857-63. doi: 10.1007/s10103-008-0633-4. Epub 2008 Dec 5.'}, {'pmid': '18649044', 'type': 'BACKGROUND', 'citation': 'Leal Junior EC, Lopes-Martins RA, Vanin AA, Baroni BM, Grosselli D, De Marchi T, Iversen VV, Bjordal JM. Effect of 830 nm low-level laser therapy in exercise-induced skeletal muscle fatigue in humans. Lasers Med Sci. 2009 May;24(3):425-31. doi: 10.1007/s10103-008-0592-9. Epub 2008 Jul 23.'}, {'pmid': '18817474', 'type': 'BACKGROUND', 'citation': 'Leal Junior EC, Lopes-Martins RA, Dalan F, Ferrari M, Sbabo FM, Generosi RA, Baroni BM, Penna SC, Iversen VV, Bjordal JM. Effect of 655-nm low-level laser therapy on exercise-induced skeletal muscle fatigue in humans. Photomed Laser Surg. 2008 Oct;26(5):419-24. doi: 10.1089/pho.2007.2160.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is an increase in muscle performance and a higher aerobic adaptation of young women submitted to chronic endurance training program associated to low level laser therapy when compared to chronic aerobic training alone.', 'detailedDescription': "The study assessed women muscle performance in isokinetic dynamometry, ventilatory parameters such as ventilatory threshold, VO2Peak, VO2Max, Ventilation. Maximal load in cycle ergometer test (Balke's protocol), Borg Scale and Heart rate were assessed too."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy young women volunteers\n* women with a beginner or moderately trained pattern of physical activity\n* body Mass Index (BMI) between 18 and 25kg/m2\n\nExclusion Criteria:\n\n* previous injury to the femoral quadriceps or hamstrings muscles (within 6 months prior to study)\n* osseous or articular disorder in the lower limbs\n* cardiovascular system disorders or systemic disease'}, 'identificationModule': {'nctId': 'NCT01391195', 'briefTitle': 'Effects of Low Level Laser Therapy (808nm) on Muscle Performance of Young Women Submitted to Physical Training', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Sao Carlos'}, 'officialTitle': 'Effects of Low Level Laser Therapy (808nm) on Muscle Performance of Young Women Submitted to Physical Training', 'orgStudyIdInfo': {'id': 'CAAE - 0100.0.135.000-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser therapy and aerobic capacity', 'description': 'Effects of low level laser therapy on aerobic capacity of young women submitted to endurance training', 'interventionNames': ['Device: Phototherapy by low level laser therapy']}], 'interventions': [{'name': 'Phototherapy by low level laser therapy', 'type': 'DEVICE', 'otherNames': ['Laser', 'Laser therapy', 'Low level laser therapy'], 'description': 'Phototherapy by low level laser therapy during 9 weeks', 'armGroupLabels': ['Laser therapy and aerobic capacity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13565-905', 'city': 'São Carlos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de Sao Carlos', 'geoPoint': {'lat': -22.0175, 'lon': -47.89083}}], 'overallOfficials': [{'name': 'Wouber Hérickson B Vieira, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de Sao Carlos'}, {'name': 'Nivaldo A Parizotto, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Federal de Sao Carlos'}, {'name': 'Cleber Ferraresi, Ms', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de Sao Carlos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Sao Carlos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Wouber Hérickson de Brito Vieira', 'oldOrganization': 'Federal University of São Carlos'}}}}