<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/NCT03803956</url>
  </required_header>
  <id_info>
    <org_study_id>397774/2011</org_study_id>
    <nct_id>NCT03803956</nct_id>
  </id_info>
  <brief_title>Infrared Low-level Laser Therapy Before Intense Progressive Running Test of High-level Soccer Players</brief_title>
  <official_title>Infrared Low-level Laser Therapy (Photobiomodulation Therapy) Before Intense Progressive Running Test of High-level Soccer Players: Effects on Functional, Muscle Damage, Inflammatory and Oxidative Stress Markers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Photobiomodulation therapy (PBMT) has recently been used to alleviate postexercise muscle&#xD;
      fatigue and enhance muscle recovery, demonstrating positive results. A previous study by the&#xD;
      investigator's research group demonstrated the optimal dose and the optimal output power (100&#xD;
      mW) for an infrared wavelength (810 nm). However, the effects of optimized PBMT on&#xD;
      performance and post-exercise recovery in high-level soccer players, to date have not been&#xD;
      evaluated.&#xD;
&#xD;
      The present research project aims to evaluate the effects of PBMT (using low-level laser&#xD;
      therapy) applied before a progressive running test on functional, muscle damage, inflammatory&#xD;
      and oxidative stress markers in high-level soccer players.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To achieve the proposed objective it will perform a randomized, crossover triple-blinded,&#xD;
      placebo-controlled trial, with high-level soccer players as volunteers.&#xD;
&#xD;
      Twenty-two volunteers will be randomly allocated to two intervention groups: active or&#xD;
      placebo PBMT before a progressive running test (ergospirometry test).&#xD;
&#xD;
      The blood samples for biochemical analysis will be obtained before and after a progressive&#xD;
      running test, and another outcomes (functional) will be obtained during the test.&#xD;
&#xD;
      The data will be collected by a blind assessor. The statistical analysis will follow the&#xD;
      intention-to-treat principles and data on functional analysis will be analyzed using the&#xD;
      paired and two-tailed t-student test. Data on biochemical analysis will be analyzed using&#xD;
      two-way ANOVA, followed by Bonferroni post hoc test.&#xD;
&#xD;
      The investigators will analyze: functional aspects (rates of oxygen uptake -VO2max (absolute&#xD;
      and relative), aerobic and anaerobic threshold and time until exhaustion), muscle damage&#xD;
      (creatine-kinase -CK and lactate dehydrogenase -LDH), inflammatory markers (IL-1β, IL-6 and&#xD;
      TNF-α) and oxidative stress markers (Thiobarbituric acid -TBARS, catalase - CAT,&#xD;
      superoxidedismutase - SOD and carbonylated proteins).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">February 16, 2019</completion_date>
  <primary_completion_date type="Actual">February 16, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>The volunteers who will receive active PBMT in the first stage of the study, will receive placebo PBMT in the second stage, while the volunteers that will receive placebo PBMT in the first stage, will receive active PBMT in the second stage of the study.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The mode of intervention (active or placebo photobiomodulation) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the laser device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of oxygen uptake (VO2max).</measure>
    <time_frame>Immediately after (1 minute) of ergospirometry test. Observation: the rates of oxygen uptake (relative and absolute) will be measured during the progressive running test.</time_frame>
    <description>The rates of oxygen uptake will be measured by an ergospirometry test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aerobic threshold.</measure>
    <time_frame>Immediately after (1 minute) of ergospirometry test. Observation: the aerobic threshold will be measured during the progressive runThe aerobic and anaerobic threshold will be measured during the progressive running test.</time_frame>
    <description>The aerobic threshold will be measured by an ergospirometry test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anaerobic threshold.</measure>
    <time_frame>Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the aerobic threshold will be measured during the progressive running test.</time_frame>
    <description>The anaerobic threshold will be measured by an ergospirometry test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of creatine kinase - CK.</measure>
    <time_frame>The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).</time_frame>
    <description>Muscle damage will be measured by blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of lactate dehydrogenase - LDH.</measure>
    <time_frame>The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).</time_frame>
    <description>Muscle damage will be measured by blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of interleukin 1 beta - IL-1b.</measure>
    <time_frame>The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).</time_frame>
    <description>Inflammation will be measured by blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of interleukin 6 - IL-6.</measure>
    <time_frame>The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).</time_frame>
    <description>Inflammation will be measured by blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of tumor necrosis factor alpha - TNF-a.</measure>
    <time_frame>The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).</time_frame>
    <description>Inflammation will be measured by blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of Thiobarbituric acid - TBARS</measure>
    <time_frame>The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).</time_frame>
    <description>Oxidative stress will be measured by blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of carbonylated proteins.</measure>
    <time_frame>The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).</time_frame>
    <description>Oxidative stress will be measured by blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of catalase - CAT.</measure>
    <time_frame>The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).</time_frame>
    <description>Oxidative stress will be measured by blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of superoxidedismutase - SOD.</measure>
    <time_frame>The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).</time_frame>
    <description>Oxidative stress will be measured by blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time until exhaustion.</measure>
    <time_frame>Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the time until exhaustion will be measured during the progressive running test.</time_frame>
    <description>The time until exhaustion will be measured by the software of ergospirometry system.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Muscle; Fatigue, Heart</condition>
  <condition>Skeletal Muscle Recovery</condition>
  <arm_group>
    <arm_group_label>Active PBMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo PBMT</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Application of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active PBMT</intervention_name>
    <description>The PBMT will be performed using the dose of 10J per diode, previously determined by a previous study and power output of 100 mW per diode, also previously determined. PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 850 J of energy. The active PBMT will be performed before a progressive running test.</description>
    <arm_group_label>Active PBMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo PBMT</intervention_name>
    <description>The placebo PBMT will per performed using the dose of 0 J per diode. Placebo PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 0 J of energy. To ensure blinding, the device emitted the same sound regardless of the programmed mode (active or placebo PBMT). The placebo PBMT will be performed before a progressive running test.</description>
    <arm_group_label>Placebo PBMT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High-level soccer players;&#xD;
&#xD;
          -  Age between 18 and 35 years;&#xD;
&#xD;
          -  Male gender;&#xD;
&#xD;
          -  Minimum of 80% participation in team practice sessions;&#xD;
&#xD;
          -  Agreement to participate through signed statement of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of musculoskeletal injury to hips or knees in previous 2 months;&#xD;
&#xD;
          -  Use of pharmacological agents or nutritional supplements;&#xD;
&#xD;
          -  Smokers and alcoholics;&#xD;
&#xD;
          -  Occurrence of musculoskeletal injury during the trial;&#xD;
&#xD;
          -  Any change in practice routine in relation to rest of the team during the trial.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ernesto Cesar Leal Junior, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nove de Julho</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory of Phototherapy and Innovative Technologies in Health</name>
      <address>
        <city>São Paulo</city>
        <zip>01504-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Ernesto Cesar Pinto Leal Junior</investigator_full_name>
    <investigator_title>Full professor</investigator_title>
  </responsible_party>
  <keyword>Photobiomodulation therapy</keyword>
  <keyword>Low-level laser therapy</keyword>
  <keyword>Performance</keyword>
  <keyword>Skeletal muscle recovery</keyword>
  <keyword>High-level soccer players</keyword>
  <keyword>Intense progressive running test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03803956
org study id: 397774/2011
nct id: NCT03803956
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Photobiomodulation therapy (PBMT) has recently been used to alleviate postexercise muscle
      fatigue and enhance muscle recovery, demonstrating positive results. A previous study by the
      investigator's research group demonstrated the optimal dose and the optimal output power (100
      mW) for an infrared wavelength (810 nm). However, the effects of optimized PBMT on
      performance and post-exercise recovery in high-level soccer players, to date have not been
      evaluated.

      The present research project aims to evaluate the effects of PBMT (using low-level laser
      therapy) applied before a progressive running test on functional, muscle damage, inflammatory
      and oxidative stress markers in high-level soccer players.
To achieve the proposed objective it will perform a randomized, crossover triple-blinded,
      placebo-controlled trial, with high-level soccer players as volunteers.

      Twenty-two volunteers will be randomly allocated to two intervention groups: active or
      placebo PBMT before a progressive running test (ergospirometry test).

      The blood samples for biochemical analysis will be obtained before and after a progressive
      running test, and another outcomes (functional) will be obtained during the test.

      The data will be collected by a blind assessor. The statistical analysis will follow the
      intention-to-treat principles and data on functional analysis will be analyzed using the
      paired and two-tailed t-student test. Data on biochemical analysis will be analyzed using
      two-way ANOVA, followed by Bonferroni post hoc test.

      The investigators will analyze: functional aspects (rates of oxygen uptake -VO2max (absolute
      and relative), aerobic and anaerobic threshold and time until exhaustion), muscle damage
      (creatine-kinase -CK and lactate dehydrogenase -LDH), inflammatory markers (IL-1β, IL-6 and
      TNF-α) and oxidative stress markers (Thiobarbituric acid -TBARS, catalase - CAT,
      superoxidedismutase - SOD and carbonylated proteins).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The volunteers who will receive active PBMT in the first stage of the study, will receive placebo PBMT in the second stage, while the volunteers that will receive placebo PBMT in the first stage, will receive active PBMT in the second stage of the study.
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The mode of intervention (active or placebo photobiomodulation) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the laser device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.
measure: Rates of oxygen uptake (VO2max).
time frame: Immediately after (1 minute) of ergospirometry test. Observation: the rates of oxygen uptake (relative and absolute) will be measured during the progressive running test.
description: The rates of oxygen uptake will be measured by an ergospirometry test.
measure: Aerobic threshold.
time frame: Immediately after (1 minute) of ergospirometry test. Observation: the aerobic threshold will be measured during the progressive runThe aerobic and anaerobic threshold will be measured during the progressive running test.
description: The aerobic threshold will be measured by an ergospirometry test.
measure: Anaerobic threshold.
time frame: Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the aerobic threshold will be measured during the progressive running test.
description: The anaerobic threshold will be measured by an ergospirometry test.
measure: Activity of creatine kinase - CK.
time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
description: Muscle damage will be measured by blood samples.
measure: Activity of lactate dehydrogenase - LDH.
time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
description: Muscle damage will be measured by blood samples.
measure: Levels of interleukin 1 beta - IL-1b.
time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
description: Inflammation will be measured by blood samples.
measure: Levels of interleukin 6 - IL-6.
time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
description: Inflammation will be measured by blood samples.
measure: Levels of tumor necrosis factor alpha - TNF-a.
time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
description: Inflammation will be measured by blood samples.
measure: Levels of Thiobarbituric acid - TBARS
time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
description: Oxidative stress will be measured by blood samples.
measure: Levels of carbonylated proteins.
time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
description: Oxidative stress will be measured by blood samples.
measure: Activity of catalase - CAT.
time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
description: Oxidative stress will be measured by blood samples.
measure: Activity of superoxidedismutase - SOD.
time frame: The blood samples will be collected 5 minutes after the ergospirometry test (progressive running test).
description: Oxidative stress will be measured by blood samples.
measure: Time until exhaustion.
time frame: Immediately after (1 minute) of ergospirometry test (progressive running test). Observation: the time until exhaustion will be measured during the progressive running test.
description: The time until exhaustion will be measured by the software of ergospirometry system.
arm group label: Active PBMT
arm group type: Active Comparator
description: Application of PBMT (Photobiomodulation Therapy) with a total dose of 850 Joules.
arm group label: Placebo PBMT
arm group type: Placebo Comparator
description: Application of placebo PBMT (Photobiomodulation Therapy) without any dose (0 Joule).
intervention type: Device
intervention name: Active PBMT
description: The PBMT will be performed using the dose of 10J per diode, previously determined by a previous study and power output of 100 mW per diode, also previously determined. PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 850 J of energy. The active PBMT will be performed before a progressive running test.
arm group label: Active PBMT
intervention type: Device
intervention name: Placebo PBMT
description: The placebo PBMT will per performed using the dose of 0 J per diode. Placebo PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 0 J of energy. To ensure blinding, the device emitted the same sound regardless of the programmed mode (active or placebo PBMT). The placebo PBMT will be performed before a progressive running test.
arm group label: Placebo PBMT
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ernesto Cesar Leal Junior, PhD
role: Principal Investigator
affiliation: University of Nove de Julho
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Ernesto Cesar Pinto Leal Junior
investigator title: Full professor
mesh term: Fatigue
sharing ipd: No