Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-02-24 @ 8:27 AM
Study NCT ID:
NCT01610232
Status:
COMPLETED
Last Update Posted:
2012-06-01
First Post:
2012-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infrared-LED During Physical Training for Rehabilitation, Physical Performance and Body Aesthetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071697', 'term': 'Cellulite'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Infrared-LED Illumination Associated with Treadmill Training', 'timeFrame': '12 months', 'description': 'Quantitative and qualitative evaluations'}], 'secondaryOutcomes': [{'measure': 'Maximal exercise testing', 'timeFrame': 'Baseline and 6 months', 'description': 'Progressive aerobic exercise testing on treadmill (Modified Bruce Protocol)'}, {'measure': 'Isokinetic concentric exercise testing', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Peak torque, power, work, and fatigue of the dominant quadriceps were measured using the isokinetic dynamometer'}, {'measure': 'Biochemical tests', 'timeFrame': 'Baseline and 6 months', 'description': 'Thyroid stimulating hormone (TSH), urea, creatinine, triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, insulin and glucose'}, {'measure': 'Quality of life', 'timeFrame': 'Baseline and 6 months', 'description': 'Menopause Rating Scale (MRS) and Women´s Health Questionnaire (WHQ)'}, {'measure': 'Dietary habits', 'timeFrame': 'Baseline and 6 months', 'description': '3-day dietary record'}, {'measure': 'Exercise tolerance and heart rate variability', 'timeFrame': 'Baseline and 6 months', 'description': 'Submaximal constant-speed testing and heart rate variability via autonomic reflex testing'}, {'measure': 'Bone mineral density', 'timeFrame': 'Baseline and 12 months', 'description': 'Bone mineral density (femoral neck, wrist, and lumbar spine) via dual-energy x-ray absorptiometry (DXA)'}, {'measure': 'Thermography', 'timeFrame': 'Baseline', 'description': 'Cutaneous temperature measurements'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infrared LED', 'Treadmill Training', 'Strength Muscle', 'Fatigue Muscle', 'Aerobic Capacity', 'Cellulite', 'Osteoporosis'], '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': '21870127', 'type': 'BACKGROUND', 'citation': 'Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26.'}, {'pmid': '21739259', 'type': 'BACKGROUND', 'citation': 'De Marchi T, Leal Junior EC, Bortoli C, Tomazoni SS, Lopes-Martins RA, Salvador M. Low-level laser therapy (LLLT) in human progressive-intensity running: effects on exercise performance, skeletal muscle status, and oxidative stress. Lasers Med Sci. 2012 Jan;27(1):231-6. doi: 10.1007/s10103-011-0955-5. Epub 2011 Jul 8.'}, {'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': '19302015', 'type': 'BACKGROUND', 'citation': 'Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Rossi RP, Grosselli D, Generosi RA, de Godoi V, Basso M, Mancalossi JL, Bjordal JM. Comparison between single-diode low-level laser therapy (LLLT) and LED multi-diode (cluster) therapy (LEDT) applications before high-intensity exercise. Photomed Laser Surg. 2009 Aug;27(4):617-23. doi: 10.1089/pho.2008.2350.'}, {'pmid': '15739174', 'type': 'BACKGROUND', 'citation': 'Karu TI, Pyatibrat LV, Afanasyeva NI. Cellular effects of low power laser therapy can be mediated by nitric oxide. Lasers Surg Med. 2005 Apr;36(4):307-14. doi: 10.1002/lsm.20148.'}, {'pmid': '17508845', 'type': 'BACKGROUND', 'citation': 'Corazza AV, Jorge J, Kurachi C, Bagnato VS. Photobiomodulation on the angiogenesis of skin wounds in rats using different light sources. Photomed Laser Surg. 2007 Apr;25(2):102-6. doi: 10.1089/pho.2006.2011.'}, {'pmid': '11776448', 'type': 'BACKGROUND', 'citation': 'Whelan HT, Smits RL Jr, Buchman EV, Whelan NT, Turner SG, Margolis DA, Cevenini V, Stinson H, Ignatius R, Martin T, Cwiklinski J, Philippi AF, Graf WR, Hodgson B, Gould L, Kane M, Chen G, Caviness J. Effect of NASA light-emitting diode irradiation on wound healing. J Clin Laser Med Surg. 2001 Dec;19(6):305-14. doi: 10.1089/104454701753342758.'}, {'pmid': '14972023', 'type': 'BACKGROUND', 'citation': 'Vladimirov YA, Osipov AN, Klebanov GI. Photobiological principles of therapeutic applications of laser radiation. Biochemistry (Mosc). 2004 Jan;69(1):81-90. doi: 10.1023/b:biry.0000016356.93968.7e.'}, {'pmid': '21749263', 'type': 'RESULT', 'citation': 'Paolillo FR, Milan JC, Aniceto IV, Barreto SG, Rebelatto JR, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. Effects of infrared-LED illumination applied during high-intensity treadmill training in postmenopausal women. Photomed Laser Surg. 2011 Sep;29(9):639-45. doi: 10.1089/pho.2010.2961. Epub 2011 Jul 12.'}, {'pmid': '21740089', 'type': 'RESULT', 'citation': 'Paolillo FR, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. New treatment of cellulite with infrared-LED illumination applied during high-intensity treadmill training. J Cosmet Laser Ther. 2011 Aug;13(4):166-71. doi: 10.3109/14764172.2011.594065.'}, {'pmid': '22382875', 'type': 'RESULT', 'citation': 'Paolillo FR, Corazza AV, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. Infrared LED irradiation applied during high-intensity treadmill training improves maximal exercise tolerance in postmenopausal women: a 6-month longitudinal study. Lasers Med Sci. 2013 Feb;28(2):415-22. doi: 10.1007/s10103-012-1062-y. Epub 2012 Mar 2.'}, {'pmid': '22089183', 'type': 'RESULT', 'citation': 'Paolillo FR, Milan JC, Bueno Pde G, Paolillo AR, Borghi-Silva A, Parizotto NA, Arena R, Kurachi C, Bagnato VS. Effects of excess body mass on strength and fatigability of quadriceps in postmenopausal women. Menopause. 2012 May;19(5):556-61. doi: 10.1097/gme.0b013e3182364e80.'}], 'seeAlsoLinks': [{'url': 'http://cepof.ifsc.usp.br/', 'label': 'Research: Biophotonics (phototherapy)'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is that the infrared-LED illumination during treadmill training can enhance physical performance in postmenopausal women. The basis for such a hypothesis is based on the fact that the light therapy during the intense metabolic stage caused by exercise may be more efficient.', 'detailedDescription': 'Phototherapy improves cellular activation via absorption of photons by chromophores present in the protein components of the mitochondrial respiratory chain - mainly NADH dehydrogenases and cytochrome C oxidase, which leads to increased electron transport, production of ATP, and tissue regeneration (skin, muscle, bone, and nerves). Moreover, phototherapy stimulates the anti-inflammatory effect with analgesia and vasodilatation. Regarding body aesthetics, phototherapy increases microcirculation, lymphatic drainage, as well as collagen synthesis for the treatment of cellulite. The objective of this study was to develop and evaluate the effects of a new clinical procedure: infrared radiation originated from LEDs associated with treadmill training in postmenopausal women. LED arrays were developed for an irradiation of a large area, such as hip and quadriceps muscles, main actuators during stance and swing phases. These body parts are furthermore areas where there is incidence of osteoporosis, mainly at the femur, localized fat deposits, and cellulite. Infrared radiation (850 nm) was selected because this spectral range shows better skin penetration compared to red interval.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women\n* Caucasian\n* 50 and 60 years of age\n* Healthy\n\nExclusion Criteria:\n\n* Neurological disease\n* Inflammatory disease\n* Pulmonary disease\n* Oncological disease\n* Cardiac disease\n* Endocrinopathy\n* Musculotendinous or articular injuries\n* Hormone replacement therapy or osteoporosis drugs\n* Cigarette smoking'}, 'identificationModule': {'nctId': 'NCT01610232', 'briefTitle': 'Infrared-LED During Physical Training for Rehabilitation, Physical Performance and Body Aesthetics', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Infrared-LED Illumination Applied During Treadmill Training in Postmenopausal Women', 'orgStudyIdInfo': {'id': '98142708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LED Group', 'description': 'Phototherapy associated with treadmill training', 'interventionNames': ['Device: Photon stimulation by light-emitting diodes (LEDs)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Group', 'description': 'Treadmill training', 'interventionNames': ['Other: Treadmill training']}, {'type': 'NO_INTERVENTION', 'label': 'Sedentary Group', 'description': 'Neither physical training nor phototherapy'}], 'interventions': [{'name': 'Photon stimulation by light-emitting diodes (LEDs)', 'type': 'DEVICE', 'description': 'Treadmill training with the application of the phototherapy was performed twice a week for 6 months, each session lasting 45 min at intensities between 85% and 90% maximal heart rate. The average power and power density on the skin were 100 mW and 39 mW/cm2, respectively. The treatment time was 45 min bilaterally in both thighs. These parameters led to an approximate fluence of 108 J/cm2.', 'armGroupLabels': ['LED Group']}, {'name': 'Treadmill training', 'type': 'OTHER', 'description': 'Treadmill training without the application of the phototherapy was performed twice a week for 6 months, each session lasting 45 min at intensities between 85% and 90% maximal heart rate', 'armGroupLabels': ['Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '369', 'city': 'São Carlos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Optics Group from Physics Institute of São Carlos (IFSC), University of São Paulo (USP)', 'geoPoint': {'lat': -22.0175, 'lon': -47.89083}}], 'overallOfficials': [{'name': 'Vanderlei S Bagnato, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physics Institute of São Carlos (IFSC), University of São Paulo (USP)'}, {'name': 'Cristina Kurachi, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physics Institute of São Carlos (IFSC), University of São Paulo (USP)'}, {'name': 'Fernanda R Paolillo, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physics Institute of São Carlos (IFSC), University of São Paulo (USP)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}, {'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Fernanda Rossi Paolillo', 'investigatorAffiliation': 'University of Sao Paulo'}}}}