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/NCT05985967</url>
    </required_header>
    <id_info>
      <org_study_id>3.997.120-1</org_study_id>
      <nct_id>NCT05985967</nct_id>
    </id_info>
    <brief_title>Therapeutic Modalities on Exercise Performance and Post-exercise Recovery of CrossFit® Athletes</brief_title>
    <official_title>Therapeutic Modalities on Exercise Performance and Post-exercise Recovery of CrossFit® Athletes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Nove de Julho</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Crossfit® is a training modality that consists in functional movements, constantly varied and&#xD;
        executed at high intensity. Both training sessions and competitions involve physically&#xD;
        demanding activities, which in addition to being performed at very high intensity also&#xD;
        involves the aerobic metabolism pathway. These characteristics led to very high metabolic and&#xD;
        muscular stress, as well as decrease in physical performance immediately after competitions&#xD;
        and training sessions. The cumulative effects of the metabolic and muscular stress can be a&#xD;
        precursor of injuries. Studies using different therapeutic modalities aiming to improve&#xD;
        post-exercise recovery are needed in order to tackle this issue.&#xD;
  &#xD;
        However, to the date there are no studies investigating the effects of different therapeutic&#xD;
        modalities in an exercise modality such as Crossfit®. Therefore, the aim of this project is&#xD;
        to assess the effects of different therapeutic modalities on performance and muscle recovery&#xD;
        of Crossfit® athletes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It will be carried out a randomized, crossover, controlled trial.&#xD;
  &#xD;
        Volunteers will be allocated to four interventions, and the order of the interventions will&#xD;
        be randomized.&#xD;
  &#xD;
        The outcomes will be obtained at baseline (prior to the Workout of the Day - WOD), and in&#xD;
        different timepoints after that.&#xD;
  &#xD;
        The WOD will be consisted in finishing as quickly as possible a sequence of three exercises&#xD;
        (Calories in Assault AirBike®, Hang Squat Clean and Box Jump Over), in a well-known series&#xD;
        model for the athletes, without rest.&#xD;
  &#xD;
        The investigators will analyze: the maximum number of free squats performed in 1 minute; the&#xD;
        activity of creatine kinase (CK); the levels of Interleukin-6 (IL-6); the ratings of&#xD;
        perceived exertion; and the volunteers satisfaction with the interventions.&#xD;
  &#xD;
        All data will be analyzed both in their absolute values and in relation to their percentage&#xD;
        variation from the values obtained in the pre-WOD (baseline) assessments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in functional capacity</measure>
      <time_frame>1hour, 24 hours and 48 hours after WOD (workout of the day).</time_frame>
      <description>The functional capacity will be assessed through the maximum number of free squat repetitions performed within 1 minute.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in the activity of creatine kinase (CK)</measure>
      <time_frame>1 hour, 24 hours and 48 hours after WOD (workout of the day).</time_frame>
      <description>The activity of CK will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the levels of interleukin-6 (IL-6)</measure>
      <time_frame>1 hour, 24 hours and 48 hours after WOD (workout of the day).</time_frame>
      <description>The levels of interleukin-6 will be analyzed from the blood samples collected from the participants through enzyme-linked immunosorbent assay (ELISA) and using specific reagent kits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participants' perceived exercise intensity</measure>
      <time_frame>1 minute after WOD (workout of the day), 1 minute post-treatment/intervention, 1 hour, 24 hours and 48 hours after WOD.</time_frame>
      <description>The perception of exercise intensity will be assessed through a 0-100 Ratings of Perceived Exertion Scale: in this scale lower score, means lower degree of fatigue and higher score, means higher degree of fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participants' satisfaction regarding the interventions</measure>
      <time_frame>48 hours after WOD (workout of the day).</time_frame>
      <description>The participants satisfaction regarding the interventions will be assessed through the LIKERT scale</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Muscle Strength</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Passive recovery for 30 minutes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PBMT-sMF</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Photobiomodulation therapy combined with static magnetic field, with a total treatment duration lasting for around 30 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Shock wave</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Shock wave therapy applied for 30 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pneumatic compression</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Pneumatic compression applied for 30 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PBMT-sMF</intervention_name>
      <description>PBMT-sMF applied in the lower limbs with different doses per muscle group.</description>
      <arm_group_label>PBMT-sMF</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Shock wave</intervention_name>
      <description>Shock wave therapy applied in the lower limbs for 30 minutes.</description>
      <arm_group_label>Shock wave</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Pneumatic compression</intervention_name>
      <description>Pneumatic compression applied in the lower limbs for 30 minutes.</description>
      <arm_group_label>Pneumatic compression</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Passive recovery</intervention_name>
      <description>Volunteers laid in supine position resting for 30 minutes.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Crossfit® amateur male athletes&#xD;
  &#xD;
            -  Do not present a history of musculoskeletal injury in the regions of the hips, knees&#xD;
               and calves in the month preceding the study;&#xD;
  &#xD;
            -  Are not using pharmacological agents;&#xD;
  &#xD;
            -  Athletes should have been practicing the sport for at least 1 year;&#xD;
  &#xD;
            -  Voluntarily commit to participate in all stages of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Present musculoskeletal or joint injuries during data collection.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <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 Pinto Leal Junior, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Full Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Heliodora Casalechi, Ph.D.</last_name>
      <phone>+55 11 3385 9134</phone>
      <email>lapit@eljconsultancy.com</email>
    </overall_contact>
    <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>
      <status>Recruiting</status>
      <contact>
        <last_name>Ernesto Cesar Pinto Leal Junior, PhD</last_name>
        <phone>+55 11 3385 9134</phone>
      </contact>
      <investigator>
        <last_name>Ernesto Cesar Pinto Leal Junior, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 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>University of Nove de Julho</investigator_affiliation>
      <investigator_full_name>Ernesto Cesar Pinto Leal Junior</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be shared upon request addressed to the principal investigator.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>The data will become available six months after the manuscript publication for five years after that.</ipd_time_frame>
      <ipd_access_criteria>All IPD that underlie results in a publication will be available on reasonable request.</ipd_access_criteria>
    </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/NCT05985967
  org study id: 3.997.120-1
  nct id: NCT05985967
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Crossfit® is a training modality that consists in functional movements, constantly varied and
        executed at high intensity. Both training sessions and competitions involve physically
        demanding activities, which in addition to being performed at very high intensity also
        involves the aerobic metabolism pathway. These characteristics led to very high metabolic and
        muscular stress, as well as decrease in physical performance immediately after competitions
        and training sessions. The cumulative effects of the metabolic and muscular stress can be a
        precursor of injuries. Studies using different therapeutic modalities aiming to improve
        post-exercise recovery are needed in order to tackle this issue.
  
        However, to the date there are no studies investigating the effects of different therapeutic
        modalities in an exercise modality such as Crossfit®. Therefore, the aim of this project is
        to assess the effects of different therapeutic modalities on performance and muscle recovery
        of Crossfit® athletes.
  It will be carried out a randomized, crossover, controlled trial.
  
        Volunteers will be allocated to four interventions, and the order of the interventions will
        be randomized.
  
        The outcomes will be obtained at baseline (prior to the Workout of the Day - WOD), and in
        different timepoints after that.
  
        The WOD will be consisted in finishing as quickly as possible a sequence of three exercises
        (Calories in Assault AirBike®, Hang Squat Clean and Box Jump Over), in a well-known series
        model for the athletes, without rest.
  
        The investigators will analyze: the maximum number of free squats performed in 1 minute; the
        activity of creatine kinase (CK); the levels of Interleukin-6 (IL-6); the ratings of
        perceived exertion; and the volunteers satisfaction with the interventions.
  
        All data will be analyzed both in their absolute values and in relation to their percentage
        variation from the values obtained in the pre-WOD (baseline) assessments.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Change in functional capacity
  time frame: 1hour, 24 hours and 48 hours after WOD (workout of the day).
  description: The functional capacity will be assessed through the maximum number of free squat repetitions performed within 1 minute.
  measure: Change in the activity of creatine kinase (CK)
  time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
  description: The activity of CK will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
  measure: Change in the levels of interleukin-6 (IL-6)
  time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
  description: The levels of interleukin-6 will be analyzed from the blood samples collected from the participants through enzyme-linked immunosorbent assay (ELISA) and using specific reagent kits.
  measure: Participants' perceived exercise intensity
  time frame: 1 minute after WOD (workout of the day), 1 minute post-treatment/intervention, 1 hour, 24 hours and 48 hours after WOD.
  description: The perception of exercise intensity will be assessed through a 0-100 Ratings of Perceived Exertion Scale: in this scale lower score, means lower degree of fatigue and higher score, means higher degree of fatigue.
  measure: Participants' satisfaction regarding the interventions
  time frame: 48 hours after WOD (workout of the day).
  description: The participants satisfaction regarding the interventions will be assessed through the LIKERT scale
  arm group label: Control
  arm group type: Other
  description: Passive recovery for 30 minutes
  arm group label: PBMT-sMF
  arm group type: Experimental
  description: Photobiomodulation therapy combined with static magnetic field, with a total treatment duration lasting for around 30 minutes.
  arm group label: Shock wave
  arm group type: Active Comparator
  description: Shock wave therapy applied for 30 minutes.
  arm group label: Pneumatic compression
  arm group type: Active Comparator
  description: Pneumatic compression applied for 30 minutes.
  intervention type: Device
  intervention name: PBMT-sMF
  description: PBMT-sMF applied in the lower limbs with different doses per muscle group.
  arm group label: PBMT-sMF
  intervention type: Device
  intervention name: Shock wave
  description: Shock wave therapy applied in the lower limbs for 30 minutes.
  arm group label: Shock wave
  intervention type: Device
  intervention name: Pneumatic compression
  description: Pneumatic compression applied in the lower limbs for 30 minutes.
  arm group label: Pneumatic compression
  intervention type: Other
  intervention name: Passive recovery
  description: Volunteers laid in supine position resting for 30 minutes.
  arm group label: Control
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ernesto Cesar Pinto Leal Junior, Ph.D.
  role: Principal Investigator
  affiliation: Full Professor
  last name: Heliodora Casalechi, Ph.D.
  phone: +55 11 3385 9134
  email: lapit@eljconsultancy.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: University of Nove de Julho
  investigator full name: Ernesto Cesar Pinto Leal Junior
  investigator title: Professor
  sharing ipd: Yes
  ipd description: Data will be shared upon request addressed to the principal investigator.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: The data will become available six months after the manuscript publication for five years after that.
  ipd access criteria: All IPD that underlie results in a publication will be available on reasonable request.