xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05989815</url>
    </required_header>
    <id_info>
      <org_study_id>62842522.2.0000.5504</org_study_id>
      <nct_id>NCT05989815</nct_id>
    </id_info>
    <brief_title>Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.</brief_title>
    <acronym>WBPME</acronym>
    <official_title>Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidade Federal de Sao Carlos</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidade Federal de Sao Carlos</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Introduction: Photobiomodulation therapy (PBMT) is based on the emission of light ranging&#xD;
        from red to near-infrared spectra by different devices based on diode lasers or&#xD;
        light-emitting diodes. These devices emitting different wavelengths can increase&#xD;
        mitochondrial activity and energy synthesis (ATP - adenosine triphosphate) that in turn can&#xD;
        help to prevent muscle damage, decrease muscle fatigue and enhance muscle performance. Thus,&#xD;
        PBMT can be a promising therapeutic resource in the sports field. Objectives: The aim of this&#xD;
        study is to verify the effect of PBMT on the muscle performance and prevention of muscle&#xD;
        damage and delayed onset muscle soreness (DOMS) in professional soccer players submitted to a&#xD;
        muscle damage protocol. Methodology: The present study is a randomized sham-controlled&#xD;
        clinical trial following the SPIRIT guidelines.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be allocated into 3 balanced randomized groups, as follows: 1) PBMT post&#xD;
        muscle damage protocol (PBMT-post); 2) PBMT pre (PBMT-pre) and 3) PBMT placebo (PBMT-sham).&#xD;
        All groups will be submitted to a) anamnesis; b) measurement of blood levels of creatine&#xD;
        phosphokinase (CK); c) delayed onset muscle soreness (DOMS); d) muscle performance tests&#xD;
        (Squat Jump test (SJ) and Counter Movement Jump (CMJ)); e) dynamometry of the knee extensor&#xD;
        muscles. Whole body PBMT will be applied according to the groups, during 10 min (sham or&#xD;
        effective), with an effective dose of 13.85 J/cm2 and irradiance of 46.17 mW/cm2. Muscle&#xD;
        damage protocol will consist of 8 exercises for lower limb muscles, with 3 sets of 10&#xD;
        repetitions each, 1 minute of rest between sets, and 2 minutes of rest between exercises.&#xD;
        Next, participants will be evaluated for levels of CK, DOMS and muscle performance (SJ, CMJ,&#xD;
        dynamometry) at 24, 48 and 72 hours after muscle damage protocol. Data will be analyzed and&#xD;
        compared between groups with a significance level of 5%.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">December 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 10, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Measurement of blood levels of creatine phosphokinase (CK)</measure>
      <time_frame>Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)</time_frame>
      <description>Measure blood levels of creatine phosphokinase (CK) at baseline and after 24h, 48h, and 72h from the muscle damage protocol.&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Muscle performance tests by Jump tests</measure>
      <time_frame>Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)</time_frame>
      <description>This muscle performance tests consists in: Squat Jump test (SJ) and Counter Movement Jump (CMJ), measured by the height of the vertical saint in centimeters (cm).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle performance tests - Dynamometry</measure>
      <time_frame>Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)</time_frame>
      <description>This muscle performance tests consists in: dynamometry of the knee extensor muscles, measured by peak force in kilograms of force (kgf) of the subject's dominant leg.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delayed onset muscle soreness (DOMS)</measure>
      <time_frame>Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)</time_frame>
      <description>The perception of DOMS (Delayed-Onset Muscle Soreness) will be evaluated using a Numeric Rating Scale (NRS) for pain The scale will be numbered from 0 to 10, with 0 indicating no muscle pain and 10 meaning that the muscles were very sore during a maximal voluntary contraction for knee extension in a sitting position, and the location of DOMS will be assessed through a specific pain map tool. Two variables, namely the extent and location of pain, will be used to estimate the outcomes.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Sports Performance</condition>
    <condition>Injury Prevention</condition>
    <condition>Muscle Damage</condition>
    <condition>Musculoskeletal Pain</condition>
    <arm_group>
      <arm_group_label>PBMT post muscle damage protocol (PBMT-post)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT.&#xD;
  PBMT will be administered using the Joovv Elite System, which has 6 panels of red Light-Emiting Diodes (LEDs) (660±10nm) and 74 panels of infrared LEDs (850±10nm), totaling 900 LEDs covering an area of 12,193 cm². Athletes will stand 20 cm in front of the device, wearing only swim shorts to expose their thigh muscles and other body areas to the light. The total irradiation time will be 20 minutes, with 10 minutes (600 seconds) of irradiation for the anterior region and another 10 minutes (600 seconds) for the posterior region. The active PBMT dose applied in each region (anterior or posterior) will be 48.97 J/cm², with an irradiance of 81.62 mW/cm².</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PBMT pre (PBMT-pre)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT.&#xD;
  PBMT will be administered using the Joovv Elite System, which has 6 panels of red Light-Emiting Diodes (LEDs) (660±10nm) and 74 panels of infrared LEDs (850±10nm), totaling 900 LEDs covering an area of 12,193 cm². Athletes will stand 20 cm in front of the device, wearing only swim shorts to expose their thigh muscles and other body areas to the light. The total irradiation time will be 20 minutes, with 10 minutes (600 seconds) of irradiation for the anterior region and another 10 minutes (600 seconds) for the posterior region. The active PBMT dose applied in each region (anterior or posterior) will be 48.97 J/cm², with an irradiance of 81.62 mW/cm².</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PBMT placebo (PBMT-sham)</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo).&#xD;
  PBMT will be administered using the Joovv Elite System, which has 6 panels of red Light-Emiting Diodes(LEDs) (660±10nm) and 74 panels of infrared LEDs (850±10nm), totaling 900 LEDs covering an area of 12,193 cm². Athletes will stand 20 cm in front of the device, wearing only swim shorts to expose their thigh muscles and other body areas to the light. The total irradiation time will be 20 minutes, with 10 minutes (600 seconds) of irradiation for the anterior region and another 10 minutes (600 seconds) for the posterior region. The Sham PBMT dose applied in each region (anterior or posterior) will be 0 J/cm², with an irradiance of 0 mW/cm².</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Muscle damage protocol training</intervention_name>
      <description>The adopted protocol of muscle damage will follow the recommendations from American College of Sports Medicine (ACSM) in 2009 for trained individuals. It consists of 8-12 repetitions above 70% of 1 Repetition Maximum (1RM) with 1 minute of rest between sets and 2 minutes between exercises. The protocol will be composed as follows: 3 sets of 10 repetitions for each exercise, with an emphasis on producing microlesions in the muscle tissue (muscle damage protocol).</description>
      <arm_group_label>PBMT placebo (PBMT-sham)</arm_group_label>
      <arm_group_label>PBMT post muscle damage protocol (PBMT-post)</arm_group_label>
      <arm_group_label>PBMT pre (PBMT-pre)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Photobiomodulation therapy (PBMT)</intervention_name>
      <description>PBMT will be administered using the Joovv Elite System, which has 6 panels of red LEDs (660±10nm) and 74 panels of infrared LEDs (850±10nm), totaling 900 LEDs covering an area of 12,193 cm². Athletes will stand 20 cm in front of the device, wearing only swim shorts to expose their thigh muscles and other body areas to the light. The total irradiation time will be 20 minutes, with 10 minutes (600 seconds) of irradiation for the anterior region and another 10 minutes (600 seconds) for the posterior region. The active PBMT dose applied in each region (anterior or posterior) will be 48.97 J/cm², with an irradiance of 81.62 milliwatt (mW)/cm². The PBMT Sham dose applied in each region (anterior or posterior) will be 0 J/cm², with an irradiance of 0 mW/cm².</description>
      <arm_group_label>PBMT placebo (PBMT-sham)</arm_group_label>
      <arm_group_label>PBMT post muscle damage protocol (PBMT-post)</arm_group_label>
      <arm_group_label>PBMT pre (PBMT-pre)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male individuals aged between 18 and 35 years, professional soccer players who engage&#xD;
               in training at least 5 times a week, will be selected.&#xD;
  &#xD;
          Data collection will be conducted at the Desportivo Brasil Football Club, located in Porto&#xD;
          Feliz, São Paulo. The sample will consist of team members, with a total of 36 athletes&#xD;
          established to compose the sample. All data collection will take place in the same&#xD;
          location.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with any impediment to physical activity or those presenting dysfunctions&#xD;
               that may impair the neuromuscular system will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cleber Ferraresi, Phd</last_name>
      <role>Study Director</role>
      <affiliation>Universidade Federal de Sao Carlos</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Italo A de Oliveira, Bachelor</last_name>
      <phone>+55 19 997190361</phone>
      <email>italoao@estudante.ufscar.br</email>
    </overall_contact>
    <location>
      <facility>
        <name>Desportivo Brasil Football Club</name>
        <address>
          <city>Porto Feliz</city>
          <state>São Paulo</state>
          <zip>18546-412</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Italo A Oliveira, Bachelor</last_name>
        <phone>+55 19 997190361</phone>
        <email>italoao@estudante.ufscar.br</email>
      </contact>
      <investigator>
        <last_name>Italo A de Oliveira, Bachelor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <reference>
      <citation>Zagatto AM, Dutra YM, Lira FS, Antunes BM, Faustini JB, Malta ES, Lopes VHF, de Poli RAB, Brisola GMP, Dos Santos GV, Rodrigues FM, Ferraresi C. Full Body Photobiomodulation Therapy to Induce Faster Muscle Recovery in Water Polo Athletes: Preliminary Results. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):766-772. doi: 10.1089/photob.2020.4803.</citation>
      <PMID>33332232</PMID>
    </reference>
    <reference>
      <citation>Thong ISK, Tan G, Lee TYC, Jensen MP. A Comparison of Pain Beliefs and Coping Strategies and Their Association with Chronic Pain Adjustment Between Singapore and United States. Pain Med. 2017 Sep 1;18(9):1668-1678. doi: 10.1093/pm/pnw237.</citation>
      <PMID>27694147</PMID>
    </reference>
    <reference>
      <citation>Lesnak J, Anderson D, Farmer B, Katsavelis D, Grindstaff TL. VALIDITY OF HAND-HELD DYNAMOMETRY IN MEASURING QUADRICEPS STRENGTH AND RATE OF TORQUE DEVELOPMENT. Int J Sports Phys Ther. 2019 Apr;14(2):180-187.</citation>
      <PMID>30997270</PMID>
    </reference>
    <reference>
      <citation>Higashi RH, Toma RL, Tucci HT, Pedroni CR, Ferreira PD, Baldini G, Aveiro MC, Borghi-Silva A, de Oliveira AS, Renno AC. Effects of low-level laser therapy on biceps braquialis muscle fatigue in young women. Photomed Laser Surg. 2013 Dec;31(12):586-94. doi: 10.1089/pho.2012.3388.</citation>
      <PMID>24320801</PMID>
    </reference>
    <reference>
      <citation>Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Psychometric properties of the portuguese version of the Pain Self-Efficacy Questionnaire. Acta Reumatol Port. 2011 Jul-Sep;36(3):260-7.</citation>
      <PMID>22113601</PMID>
    </reference>
    <reference>
      <citation>Enwemeka CS. Light is light. Photomed Laser Surg. 2005 Apr;23(2):159-60. doi: 10.1089/pho.2005.23.159. No abstract available.</citation>
      <PMID>15910178</PMID>
    </reference>
    <reference>
      <citation>Denadai AS, de Carvalho Pde T, dos Reis FA, Belchior AC, Pereira DM, Dourado DM, Silva IS, de Oliveira LV. Morphometric and histological analysis of low-power laser influence on bone morphogenetic protein in bone defects repair. Lasers Med Sci. 2009 Sep;24(5):689-95. doi: 10.1007/s10103-008-0595-6. Epub 2008 Sep 12.</citation>
      <PMID>18787760</PMID>
    </reference>
    <reference>
      <citation>Dornelles MP, Fritsch CG, Sonda FC, Johnson DS, Leal-Junior ECP, Vaz MA, Baroni BM. Photobiomodulation therapy as a tool to prevent hamstring strain injuries by reducing soccer-induced fatigue on hamstring muscles. Lasers Med Sci. 2019 Aug;34(6):1177-1184. doi: 10.1007/s10103-018-02709-w. Epub 2019 Jan 3.</citation>
      <PMID>30607719</PMID>
    </reference>
    <reference>
      <citation>Cressoni MD, Dib Giusti HH, Casarotto RA, Anaruma CA. The effects of a 785-nm AlGaInP laser on the regeneration of rat anterior tibialis muscle after surgically-induced injury. Photomed Laser Surg. 2008 Oct;26(5):461-6. doi: 10.1089/pho.2007.2150.</citation>
      <PMID>18800950</PMID>
    </reference>
    <reference>
      <citation>Azuma RHE, Merlo JK, Jacinto JL, Borim JM, da Silva RA, Pacagnelli FL, Nunes JP, Ribeiro AS, Aguiar AF. Photobiomodulation Therapy at 808 nm Does Not Improve Biceps Brachii Performance to Exhaustion and Delayed-Onset Muscle Soreness in Young Adult Women: A Randomized, Controlled, Crossover Trial. Front Physiol. 2021 Jun 10;12:664582. doi: 10.3389/fphys.2021.664582. eCollection 2021.</citation>
      <PMID>34177615</PMID>
    </reference>
    <reference>
      <citation>Julio CE, Antonialli FC, Nascimento TMD, Sa KA, Barton GJ, Lucareli PRG. The Movement Deviation Profile Can Differentiate Faller and Non-Faller Older Adults. J Gerontol A Biol Sci Med Sci. 2023 Aug 27;78(9):1651-1658. doi: 10.1093/gerona/glad141.</citation>
      <PMID>37279546</PMID>
    </reference>
    <reference>
      <citation>Anders JJ, Arany PR, Baxter GD, Lanzafame RJ. Light-Emitting Diode Therapy and Low-Level Light Therapy Are Photobiomodulation Therapy. Photobiomodul Photomed Laser Surg. 2019 Feb;37(2):63-65. doi: 10.1089/photob.2018.4600. Epub 2019 Jan 24. No abstract available.</citation>
      <PMID>31050924</PMID>
    </reference>
    <reference>
      <citation>Qureshi MA, Mcisaac L, Schlyer D, Hupf HB, Al-Watban FA, Lewall D. Production of 123I as iodide by distillation. Int J Nucl Med Biol. 1985;12(1):57-8. doi: 10.1016/0047-0740(85)90014-2. No abstract available.</citation>
      <PMID>4008167</PMID>
    </reference>
    <reference>
      <citation>American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.</citation>
      <PMID>19204579</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidade Federal de Sao Carlos</investigator_affiliation>
      <investigator_full_name>Italo Amaral de Oliveira</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>phototherapy</keyword>
    <keyword>laser therapy</keyword>
    <keyword>muscle fatigue</keyword>
    <keyword>muscle damage</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Musculoskeletal Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05989815
  org study id: 62842522.2.0000.5504
  nct id: NCT05989815
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Introduction: Photobiomodulation therapy (PBMT) is based on the emission of light ranging
        from red to near-infrared spectra by different devices based on diode lasers or
        light-emitting diodes. These devices emitting different wavelengths can increase
        mitochondrial activity and energy synthesis (ATP - adenosine triphosphate) that in turn can
        help to prevent muscle damage, decrease muscle fatigue and enhance muscle performance. Thus,
        PBMT can be a promising therapeutic resource in the sports field. Objectives: The aim of this
        study is to verify the effect of PBMT on the muscle performance and prevention of muscle
        damage and delayed onset muscle soreness (DOMS) in professional soccer players submitted to a
        muscle damage protocol. Methodology: The present study is a randomized sham-controlled
        clinical trial following the SPIRIT guidelines.
  Participants will be allocated into 3 balanced randomized groups, as follows: 1) PBMT post
        muscle damage protocol (PBMT-post); 2) PBMT pre (PBMT-pre) and 3) PBMT placebo (PBMT-sham).
        All groups will be submitted to a) anamnesis; b) measurement of blood levels of creatine
        phosphokinase (CK); c) delayed onset muscle soreness (DOMS); d) muscle performance tests
        (Squat Jump test (SJ) and Counter Movement Jump (CMJ)); e) dynamometry of the knee extensor
        muscles. Whole body PBMT will be applied according to the groups, during 10 min (sham or
        effective), with an effective dose of 13.85 J/cm2 and irradiance of 46.17 mW/cm2. Muscle
        damage protocol will consist of 8 exercises for lower limb muscles, with 3 sets of 10
        repetitions each, 1 minute of rest between sets, and 2 minutes of rest between exercises.
        Next, participants will be evaluated for levels of CK, DOMS and muscle performance (SJ, CMJ,
        dynamometry) at 24, 48 and 72 hours after muscle damage protocol. Data will be analyzed and
        compared between groups with a significance level of 5%.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Measurement of blood levels of creatine phosphokinase (CK)
  time frame: Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
  description: Measure blood levels of creatine phosphokinase (CK) at baseline and after 24h, 48h, and 72h from the muscle damage protocol."
  measure: Muscle performance tests by Jump tests
  time frame: Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
  description: This muscle performance tests consists in: Squat Jump test (SJ) and Counter Movement Jump (CMJ), measured by the height of the vertical saint in centimeters (cm).
  measure: Muscle performance tests - Dynamometry
  time frame: Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
  description: This muscle performance tests consists in: dynamometry of the knee extensor muscles, measured by peak force in kilograms of force (kgf) of the subject's dominant leg.
  measure: Delayed onset muscle soreness (DOMS)
  time frame: Total of four consecutive days, from the 1st-day baseline to the 4th day (72 hours after the protocol)
  description: The perception of DOMS (Delayed-Onset Muscle Soreness) will be evaluated using a Numeric Rating Scale (NRS) for pain The scale will be numbered from 0 to 10, with 0 indicating no muscle pain and 10 meaning that the muscles were very sore during a maximal voluntary contraction for knee extension in a sitting position, and the location of DOMS will be assessed through a specific pain map tool. Two variables, namely the extent and location of pain, will be used to estimate the outcomes.
  arm group label: PBMT post muscle damage protocol (PBMT-post)
  arm group type: Experimental
  description: Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT.
  PBMT will be administered using the Joovv Elite System, which has 6 panels of red Light-Emiting Diodes (LEDs) (660±10nm) and 74 panels of infrared LEDs (850±10nm), totaling 900 LEDs covering an area of 12,193 cm². Athletes will stand 20 cm in front of the device, wearing only swim shorts to expose their thigh muscles and other body areas to the light. The total irradiation time will be 20 minutes, with 10 minutes (600 seconds) of irradiation for the anterior region and another 10 minutes (600 seconds) for the posterior region. The active PBMT dose applied in each region (anterior or posterior) will be 48.97 J/cm², with an irradiance of 81.62 mW/cm².
  arm group label: PBMT pre (PBMT-pre)
  arm group type: Experimental
  description: Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT.
  PBMT will be administered using the Joovv Elite System, which has 6 panels of red Light-Emiting Diodes (LEDs) (660±10nm) and 74 panels of infrared LEDs (850±10nm), totaling 900 LEDs covering an area of 12,193 cm². Athletes will stand 20 cm in front of the device, wearing only swim shorts to expose their thigh muscles and other body areas to the light. The total irradiation time will be 20 minutes, with 10 minutes (600 seconds) of irradiation for the anterior region and another 10 minutes (600 seconds) for the posterior region. The active PBMT dose applied in each region (anterior or posterior) will be 48.97 J/cm², with an irradiance of 81.62 mW/cm².
  arm group label: PBMT placebo (PBMT-sham)
  arm group type: Sham Comparator
  description: Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo).
  PBMT will be administered using the Joovv Elite System, which has 6 panels of red Light-Emiting Diodes(LEDs) (660±10nm) and 74 panels of infrared LEDs (850±10nm), totaling 900 LEDs covering an area of 12,193 cm². Athletes will stand 20 cm in front of the device, wearing only swim shorts to expose their thigh muscles and other body areas to the light. The total irradiation time will be 20 minutes, with 10 minutes (600 seconds) of irradiation for the anterior region and another 10 minutes (600 seconds) for the posterior region. The Sham PBMT dose applied in each region (anterior or posterior) will be 0 J/cm², with an irradiance of 0 mW/cm².
  intervention type: Other
  intervention name: Muscle damage protocol training
  description: The adopted protocol of muscle damage will follow the recommendations from American College of Sports Medicine (ACSM) in 2009 for trained individuals. It consists of 8-12 repetitions above 70% of 1 Repetition Maximum (1RM) with 1 minute of rest between sets and 2 minutes between exercises. The protocol will be composed as follows: 3 sets of 10 repetitions for each exercise, with an emphasis on producing microlesions in the muscle tissue (muscle damage protocol).
  arm group label: PBMT placebo (PBMT-sham)
  arm group label: PBMT post muscle damage protocol (PBMT-post)
  arm group label: PBMT pre (PBMT-pre)
  intervention type: Device
  intervention name: Photobiomodulation therapy (PBMT)
  description: PBMT will be administered using the Joovv Elite System, which has 6 panels of red LEDs (660±10nm) and 74 panels of infrared LEDs (850±10nm), totaling 900 LEDs covering an area of 12,193 cm². Athletes will stand 20 cm in front of the device, wearing only swim shorts to expose their thigh muscles and other body areas to the light. The total irradiation time will be 20 minutes, with 10 minutes (600 seconds) of irradiation for the anterior region and another 10 minutes (600 seconds) for the posterior region. The active PBMT dose applied in each region (anterior or posterior) will be 48.97 J/cm², with an irradiance of 81.62 milliwatt (mW)/cm². The PBMT Sham dose applied in each region (anterior or posterior) will be 0 J/cm², with an irradiance of 0 mW/cm².
  arm group label: PBMT placebo (PBMT-sham)
  arm group label: PBMT post muscle damage protocol (PBMT-post)
  arm group label: PBMT pre (PBMT-pre)
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cleber Ferraresi, Phd
  role: Study Director
  affiliation: Universidade Federal de Sao Carlos
  last name: Italo A de Oliveira, Bachelor
  phone: +55 19 997190361
  email: italoao@estudante.ufscar.br
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Brazil
  citation: Zagatto AM, Dutra YM, Lira FS, Antunes BM, Faustini JB, Malta ES, Lopes VHF, de Poli RAB, Brisola GMP, Dos Santos GV, Rodrigues FM, Ferraresi C. Full Body Photobiomodulation Therapy to Induce Faster Muscle Recovery in Water Polo Athletes: Preliminary Results. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):766-772. doi: 10.1089/photob.2020.4803.
  PMID: 33332232
  citation: Thong ISK, Tan G, Lee TYC, Jensen MP. A Comparison of Pain Beliefs and Coping Strategies and Their Association with Chronic Pain Adjustment Between Singapore and United States. Pain Med. 2017 Sep 1;18(9):1668-1678. doi: 10.1093/pm/pnw237.
  PMID: 27694147
  citation: Lesnak J, Anderson D, Farmer B, Katsavelis D, Grindstaff TL. VALIDITY OF HAND-HELD DYNAMOMETRY IN MEASURING QUADRICEPS STRENGTH AND RATE OF TORQUE DEVELOPMENT. Int J Sports Phys Ther. 2019 Apr;14(2):180-187.
  PMID: 30997270
  citation: Higashi RH, Toma RL, Tucci HT, Pedroni CR, Ferreira PD, Baldini G, Aveiro MC, Borghi-Silva A, de Oliveira AS, Renno AC. Effects of low-level laser therapy on biceps braquialis muscle fatigue in young women. Photomed Laser Surg. 2013 Dec;31(12):586-94. doi: 10.1089/pho.2012.3388.
  PMID: 24320801
  citation: Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Psychometric properties of the portuguese version of the Pain Self-Efficacy Questionnaire. Acta Reumatol Port. 2011 Jul-Sep;36(3):260-7.
  PMID: 22113601
  citation: Enwemeka CS. Light is light. Photomed Laser Surg. 2005 Apr;23(2):159-60. doi: 10.1089/pho.2005.23.159. No abstract available.
  PMID: 15910178
  citation: Denadai AS, de Carvalho Pde T, dos Reis FA, Belchior AC, Pereira DM, Dourado DM, Silva IS, de Oliveira LV. Morphometric and histological analysis of low-power laser influence on bone morphogenetic protein in bone defects repair. Lasers Med Sci. 2009 Sep;24(5):689-95. doi: 10.1007/s10103-008-0595-6. Epub 2008 Sep 12.
  PMID: 18787760
  citation: Dornelles MP, Fritsch CG, Sonda FC, Johnson DS, Leal-Junior ECP, Vaz MA, Baroni BM. Photobiomodulation therapy as a tool to prevent hamstring strain injuries by reducing soccer-induced fatigue on hamstring muscles. Lasers Med Sci. 2019 Aug;34(6):1177-1184. doi: 10.1007/s10103-018-02709-w. Epub 2019 Jan 3.
  PMID: 30607719
  citation: Cressoni MD, Dib Giusti HH, Casarotto RA, Anaruma CA. The effects of a 785-nm AlGaInP laser on the regeneration of rat anterior tibialis muscle after surgically-induced injury. Photomed Laser Surg. 2008 Oct;26(5):461-6. doi: 10.1089/pho.2007.2150.
  PMID: 18800950
  citation: Azuma RHE, Merlo JK, Jacinto JL, Borim JM, da Silva RA, Pacagnelli FL, Nunes JP, Ribeiro AS, Aguiar AF. Photobiomodulation Therapy at 808 nm Does Not Improve Biceps Brachii Performance to Exhaustion and Delayed-Onset Muscle Soreness in Young Adult Women: A Randomized, Controlled, Crossover Trial. Front Physiol. 2021 Jun 10;12:664582. doi: 10.3389/fphys.2021.664582. eCollection 2021.
  PMID: 34177615
  citation: Julio CE, Antonialli FC, Nascimento TMD, Sa KA, Barton GJ, Lucareli PRG. The Movement Deviation Profile Can Differentiate Faller and Non-Faller Older Adults. J Gerontol A Biol Sci Med Sci. 2023 Aug 27;78(9):1651-1658. doi: 10.1093/gerona/glad141.
  PMID: 37279546
  citation: Anders JJ, Arany PR, Baxter GD, Lanzafame RJ. Light-Emitting Diode Therapy and Low-Level Light Therapy Are Photobiomodulation Therapy. Photobiomodul Photomed Laser Surg. 2019 Feb;37(2):63-65. doi: 10.1089/photob.2018.4600. Epub 2019 Jan 24. No abstract available.
  PMID: 31050924
  citation: Qureshi MA, Mcisaac L, Schlyer D, Hupf HB, Al-Watban FA, Lewall D. Production of 123I as iodide by distillation. Int J Nucl Med Biol. 1985;12(1):57-8. doi: 10.1016/0047-0740(85)90014-2. No abstract available.
  PMID: 4008167
  citation: American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
  PMID: 19204579
  responsible party type: Principal Investigator
  investigator affiliation: Universidade Federal de Sao Carlos
  investigator full name: Italo Amaral de Oliveira
  investigator title: Principal Investigator
  mesh term: Musculoskeletal Pain
  sharing ipd: No