Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT03593733
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2018-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Photobiomodulation Therapy (PBMT) and a Cold-Water Immersion (CWI) in Recovery Soccer Player: Analysis of Biochemical Markers of Recovery and Muscular Oxidative Stress.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum levels of Creatine Kinase (CK) activity', 'timeFrame': 'Baseline; immediatily soccer match and 48 hours after.', 'description': 'Sample of Blood'}, {'measure': 'Serum levels Thiobarbituric acid reactive substances -TBARS', 'timeFrame': 'Baseline; immediatily soccer match and 48 hours after.', 'description': 'Sample of Blood'}, {'measure': 'Serum levels Superoxide Dismutase -SOD', 'timeFrame': 'Baseline; immediatily soccer match and 48 hours after.', 'description': 'Sample of Blood'}, {'measure': 'Serum levels Catalase - CAT', 'timeFrame': 'Baseline; immediatily soccer match and 48 hours after.', 'description': 'Sample of Blood'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soccer', 'Fatigue', 'Oxidative Stress', 'Recovery', 'Cold Water Immersion', 'Photobiomodulation Therapy']}, 'referencesModule': {'references': [{'pmid': '23743793', 'type': 'BACKGROUND', 'citation': 'Versey NG, Halson SL, Dawson BT. Water immersion recovery for athletes: effect on exercise performance and practical recommendations. Sports Med. 2013 Nov;43(11):1101-30. doi: 10.1007/s40279-013-0063-8.'}, {'pmid': '26888646', 'type': 'BACKGROUND', 'citation': 'Ihsan M, Watson G, Abbiss CR. What are the Physiological Mechanisms for Post-Exercise Cold Water Immersion in the Recovery from Prolonged Endurance and Intermittent Exercise? Sports Med. 2016 Aug;46(8):1095-109. doi: 10.1007/s40279-016-0483-3.'}, {'pmid': '23315753', 'type': 'BACKGROUND', 'citation': 'Nedelec M, McCall A, Carling C, Legall F, Berthoin S, Dupont G. Recovery in soccer : part ii-recovery strategies. Sports Med. 2013 Jan;43(1):9-22. doi: 10.1007/s40279-012-0002-0.'}, {'pmid': '29090398', 'type': 'BACKGROUND', 'citation': 'Vanin AA, Verhagen E, Barboza SD, Costa LOP, Leal-Junior ECP. Photobiomodulation therapy for the improvement of muscular performance and reduction of muscular fatigue associated with exercise in healthy people: a systematic review and meta-analysis. Lasers Med Sci. 2018 Jan;33(1):181-214. doi: 10.1007/s10103-017-2368-6. Epub 2017 Oct 31.'}, {'pmid': '29099680', 'type': 'BACKGROUND', 'citation': 'de Oliveira AR, Vanin AA, Tomazoni SS, Miranda EF, Albuquerque-Pontes GM, De Marchi T, Dos Santos Grandinetti V, de Paiva PRV, Imperatori TBG, de Carvalho PTC, Bjordal JM, Leal-Junior ECP. Pre-Exercise Infrared Photobiomodulation Therapy (810 nm) in Skeletal Muscle Performance and Postexercise Recovery in Humans: What Is the Optimal Power Output? Photomed Laser Surg. 2017 Nov;35(11):595-603. doi: 10.1089/pho.2017.4343.'}, {'pmid': '28054262', 'type': 'BACKGROUND', 'citation': 'De Marchi T, Schmitt VM, Machado GP, de Sene JS, de Col CD, Tairova O, Salvador M, Leal-Junior EC. Does photobiomodulation therapy is better than cryotherapy in muscle recovery after a high-intensity exercise? A randomized, double-blind, placebo-controlled clinical trial. Lasers Med Sci. 2017 Feb;32(2):429-437. doi: 10.1007/s10103-016-2139-9. Epub 2017 Jan 5.'}, {'pmid': '16195010', 'type': 'RESULT', 'citation': 'Reilly T, Ekblom B. The use of recovery methods post-exercise. J Sports Sci. 2005 Jun;23(6):619-27. doi: 10.1080/02640410400021302.'}, {'pmid': '23046224', 'type': 'RESULT', 'citation': 'Nedelec M, McCall A, Carling C, Legall F, Berthoin S, Dupont G. Recovery in soccer: part I - post-match fatigue and time course of recovery. Sports Med. 2012 Dec 1;42(12):997-1015. doi: 10.2165/11635270-000000000-00000.'}, {'pmid': '16937951', 'type': 'RESULT', 'citation': 'Wilcock IM, Cronin JB, Hing WA. Physiological response to water immersion: a method for sport recovery? Sports Med. 2006;36(9):747-65. doi: 10.2165/00007256-200636090-00003.'}, {'pmid': '26464795', 'type': 'RESULT', 'citation': 'Murray A, Cardinale M. Cold applications for recovery in adolescent athletes: a systematic review and meta analysis. Extrem Physiol Med. 2015 Oct 12;4:17. doi: 10.1186/s13728-015-0035-8. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': "Competitive soccer engages many of the body's systems to a major extent. The musculoskeletal, nervous, immune and metabolic systems are stressed to a point where recovery strategies post-exercise become influential in preparing for the next match.\n\nRecovery from exercise can be an important factor in performance during repeated bouts of exercise. In a tournament situation, where athletes may compete numerous times over a few days, enhancing recovery may provide a competitive advantage. Recent work has highlighted that the aim of most recovery interventions is to return psychological, physiological, and performance variables to the 'pre-exercise' level or to baseline conditions identified in the absence of fatigue.\n\nThe post-exercise cold water immersion (CWI) through its primary ability to decrease tissue temperature and blood flow, is purported to facilitate recovery by ameliorating hyperthermia and subsequent alterations to the central nervous system (CNS), reducing cardiovascular strain, removing accumulated muscle metabolic by-products, attenuating exercise-induced muscle damage (EIMD) and improving autonomic nervous system function. All these alterations provoke important physiological changes for the recovery of the athlete.\n\nScientific evidence for other strategies reviewed in their ability to accelerate the return to the initial level of performance is still lacking. These include active recovery, stretching, compression garments, massage and electrical stimulation. While this does not mean that these strategies do not aid the recovery process, the protocols implemented up until now do not significantly accelerate the return to initial levels of performance in comparison with a control condition.\n\nAmong these new strategies, Photobimodulation therapy - PBMT using low-level laser therapy (LLLT) and light-emitting diode therapy (LEDT) has been the focus of important research insights science in recent years. The PBMT has been used to increase muscle performance and reduces muscle fatigue signals. The mechanism proposed for the use of PBMT in sports and exercise is the increase in cytochrome c-oxidase in skeletal muscle fibers that lead to upregulation of mitochondrial activity, which increases ATP production promoting more energy for the muscle and decreases oxidative stress and reactive oxygen species production.\n\nConsidering that the consented CWI is already used with good results in soccer athletes, however it has some drawbacks such as the time of application and the inconvenience caused by the application of cold and the new possibilities presented in the literature of the use of PBMT we propose to carry out this study. To address these issues, the present study aims to investigate and analyze biological markers on oxidative stress and muscle damage in soccer athletes after a match submitted to recovery strategies through CWI and PBMT", 'detailedDescription': 'In elite soccer, players are frequently required to play consecutive matches interspersed by 3 days and complete physical performance recovery may not be achieved. Incomplete recovery might result in underperformance and injury. During congested schedules, recovery strategies are therefore required to alleviate post-match fatigue, regain performance faster and reduce the risk of injury. Recovery from exercise can be an important factor in performance during repeated bouts of exercise.\n\nThe strenuous exercise induces muscle cell structural damage, which results in increased plasma concentrations of muscle enzymes such as CK and LDH. The efflux of CK and LDH proteins from muscle may be attributed to increased permeability of the plasma membrane or intramuscular vasculature (or both). Thus, a reduction in these markers has been proposed as an indicator of recovery after strenuous exercise that induces muscle damage.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Voluntary athletes were soccer players aged 16 to 17 years, healthy, male, with no history of autoimmune diseases, who did not present previous muscular lesions in the period of 3 months prior to the study and who are participating of the category championships.\n\n\\-\n\nExclusion Criteria:\n\n* No soccer playres.'}, 'identificationModule': {'nctId': 'NCT03593733', 'briefTitle': 'Comparison Between Photobiomodulation Therapy (PBMT) and a Cold-Water Immersion (CWI) in Recovery Soccer Player: Analysis of Biochemical Markers of Recovery and Muscular Oxidative Stress.', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Comparison Between Photobiomodulation Therapy (PBMT) and a Cold-Water Immersion (CWI) in Recovery Soccer Player: Analysis of Biochemical Markers of Recovery and Muscular Oxidative Stress.', 'orgStudyIdInfo': {'id': 'PBTM CWI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cold Water Immersion', 'description': 'Cold Water Immersion', 'interventionNames': ['Other: Cold Water Immersion']}, {'type': 'EXPERIMENTAL', 'label': 'Photobiomodulation Therapy', 'description': 'Photobiomodulation Therapy', 'interventionNames': ['Other: Photobiomodulation Therapy']}], 'interventions': [{'name': 'Photobiomodulation Therapy', 'type': 'OTHER', 'otherNames': ['Cold Water Immersion'], 'description': 'Photobiomodulation Therapy', 'armGroupLabels': ['Photobiomodulation Therapy']}, {'name': 'Cold Water Immersion', 'type': 'OTHER', 'description': 'Cold Water Immersion', 'armGroupLabels': ['Cold Water Immersion']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paulo de Tarso Camillo de Carvalho, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nove de Julho'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LUCIANA MARIA MALOSA SAMPAIO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Postgraduate Program in Rehabilitation Science', 'investigatorFullName': 'LUCIANA MARIA MALOSA SAMPAIO', 'investigatorAffiliation': 'University of Nove de Julho'}}}}