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/NCT05994092</url>
    </required_header>
    <id_info>
      <org_study_id>TK03/2023</org_study_id>
      <nct_id>NCT05994092</nct_id>
    </id_info>
    <brief_title>Influence of Voluntary Isocapnic Hyperpnea on Blood Lactate Level and Rate of Perceived Exertion</brief_title>
    <official_title>Influence of Voluntary Isocapnic Hyperpnea on Blood Lactate Level and Rate of Perceived Exertion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Sport - National Research Institute, Poland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Sport - National Research Institute, Poland</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>
        All the study participants performed the Wingate Anaerobic Test (WAnT) with maximal effort.&#xD;
        The experimental group (E) performed a 3-minute recovery protocol based on low-intensity&#xD;
        breathing Voluntary Isocapnic Hyperpnea exercises 20 minuter after cessation of the exercise,&#xD;
        whereas the control group (C) used passive recovery only. All study participants were advised&#xD;
        to sit during the 30-minute period, with minimal walking in order to meet the physiological&#xD;
        needs allowed. The blood samples were taken 3 minutes and 30 minutes after cessation of the&#xD;
        exercise to measure the bLa. The Borg CR-10 Scale was presented to the participants 3 minutes&#xD;
        and 30 minutes after cessation of the exercise to measure the rate of perceived exertion&#xD;
        (RPE) (Borg, 1998).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All the study participants performed the Wingate Anaerobic Test (WAnT) with maximal effort.&#xD;
        The experimental group (E) performed a 3-minute recovery protocol based on low-intensity&#xD;
        breathing VIH exercises 20 minuter after cessation of the exercise, whereas the control group&#xD;
        (C) used passive recovery only. All study participants were advised to sit during the&#xD;
        30-minute period, with minimal walking in order to meet the physiological needs allowed. The&#xD;
        blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure&#xD;
        the bLa. The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes&#xD;
        after cessation of the exercise to measure the rate of perceived exertion (RPE).&#xD;
  &#xD;
        WAnT was conducted using a Monark 874E Cycle Ergometer (Monark Exercise AB, Sweden). Prior to&#xD;
        the test, a standard warm-up of 5 minutes was performed with a load of 0.8-1.2 W/kg. Then,&#xD;
        athletes performed a maximal 6-second sprint with a load adjusted to 7.5% of the individual&#xD;
        body weight. Following a 2-minute rest period, the athletes underwent a 30-second WAnT with&#xD;
        the load adjusted to 7.5% of the individual body weight. The objective for the subjects was&#xD;
        to achieve the highest possible peak power as fast as possible and maintain the highest power&#xD;
        output throughout the whole test duration. Loud and dynamic verbal encouragement was&#xD;
        provided. The testing took place between 9:00 and 10:30 AM. The basic mechanical parameters&#xD;
        of the exercise, including performed work and maximum power, were computed with dedicated&#xD;
        software (MCE 6.0 - JBA Z. Staniak, Poland) linked to the cycle ergometer.&#xD;
  &#xD;
        The recovery protocol consisted of 3' of breathing with 20 breaths·min-1 frequency. The&#xD;
        Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc, Kelowna, Canada) with 6-liter&#xD;
        bags were used. The protocol was performed in a seating position.&#xD;
  &#xD;
        Blood samples were taken from fingertips by skilled technicians to 20 uL capillary tubes. bLa&#xD;
        was measured with Super GL2 analyzer (Dr. Müller Gerätebau GmbH, Freital, Germany).&#xD;
  &#xD;
        Whereas participants and data collectors were aware of the allocated training method, the&#xD;
        laboratory technicians performing biochemistry assays were kept blinded to the allocation.&#xD;
        The participants were assigned at random to either E or C group to perform VIH protocol under&#xD;
        a supervision of qualified physiotherapist.&#xD;
  &#xD;
        Stratified randomization to assign the participants was used. First, the participants were&#xD;
        assigned to subgroups based on the membership in National Development or National Elite Team.&#xD;
        Then, the participants were assigned to subgroups based on the gender. Then, the participants&#xD;
        were assigned to E or C group based on the coin toss.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 10, 2023</start_date>
    <completion_date type="Actual">July 30, 2023</completion_date>
    <primary_completion_date type="Actual">July 30, 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>
      <intervention_model_description>Parallel Group Randomized Controlled Trial</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in blood lactate (bLa)</measure>
      <time_frame>30 minutes</time_frame>
      <description>The blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure the bLa.&#xD;
  Blood samples were taken from fingertips by skilled technicians to 20 uL capillary tubes. bLa was measured with Super GL2 analyzer (Dr. Müller Gerätebau GmbH, Freital, Germany).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in rate of perceived exertion (RPE)</measure>
      <time_frame>30 minutes</time_frame>
      <description>The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes after cessation of the exercise to measure the rate of perceived exertion (RPE) (Borg, 1998).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">39</enrollment>
    <condition>Blood Lactate Decrease</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Voluntary Isocapnic Hyperpnea</intervention_name>
      <description>The protocol of 3' of breathing with 20 breaths·min-1 frequency. The Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc, Kelowna, Canada) with 6-liter bags were used. The protocol was performed in a seating position.</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The inclusion criteria:&#xD;
  &#xD;
            -  valid medical certificate to compete in speedskating,&#xD;
  &#xD;
            -  lack of previous experience with RMT,&#xD;
  &#xD;
            -  at least 6 years of athletic training.&#xD;
  &#xD;
          The exclusion criteria:&#xD;
  &#xD;
            -  any chronic medical condition,&#xD;
  &#xD;
            -  any acute medical condition within last 3 months,&#xD;
  &#xD;
            -  any ongoing medication intake.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Institute of Sport - National Research Institute</name>
        <address>
          <city>Warsaw</city>
          <zip>01-982</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Institute of Sport - National Research Institute, Poland</investigator_affiliation>
      <investigator_full_name>Tomasz Kowalski</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Voluntary Isocapnic Hyperpnea</keyword>
    <keyword>Lactate Clearance</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Upon reasonable request.</ipd_description>
    </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/NCT05994092
  org study id: TK03/2023
  nct id: NCT05994092
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  All the study participants performed the Wingate Anaerobic Test (WAnT) with maximal effort.
        The experimental group (E) performed a 3-minute recovery protocol based on low-intensity
        breathing Voluntary Isocapnic Hyperpnea exercises 20 minuter after cessation of the exercise,
        whereas the control group (C) used passive recovery only. All study participants were advised
        to sit during the 30-minute period, with minimal walking in order to meet the physiological
        needs allowed. The blood samples were taken 3 minutes and 30 minutes after cessation of the
        exercise to measure the bLa. The Borg CR-10 Scale was presented to the participants 3 minutes
        and 30 minutes after cessation of the exercise to measure the rate of perceived exertion
        (RPE) (Borg, 1998).
  All the study participants performed the Wingate Anaerobic Test (WAnT) with maximal effort.
        The experimental group (E) performed a 3-minute recovery protocol based on low-intensity
        breathing VIH exercises 20 minuter after cessation of the exercise, whereas the control group
        (C) used passive recovery only. All study participants were advised to sit during the
        30-minute period, with minimal walking in order to meet the physiological needs allowed. The
        blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure
        the bLa. The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes
        after cessation of the exercise to measure the rate of perceived exertion (RPE).
  
        WAnT was conducted using a Monark 874E Cycle Ergometer (Monark Exercise AB, Sweden). Prior to
        the test, a standard warm-up of 5 minutes was performed with a load of 0.8-1.2 W/kg. Then,
        athletes performed a maximal 6-second sprint with a load adjusted to 7.5% of the individual
        body weight. Following a 2-minute rest period, the athletes underwent a 30-second WAnT with
        the load adjusted to 7.5% of the individual body weight. The objective for the subjects was
        to achieve the highest possible peak power as fast as possible and maintain the highest power
        output throughout the whole test duration. Loud and dynamic verbal encouragement was
        provided. The testing took place between 9:00 and 10:30 AM. The basic mechanical parameters
        of the exercise, including performed work and maximum power, were computed with dedicated
        software (MCE 6.0 - JBA Z. Staniak, Poland) linked to the cycle ergometer.
  
        The recovery protocol consisted of 3' of breathing with 20 breaths·min-1 frequency. The
        Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc, Kelowna, Canada) with 6-liter
        bags were used. The protocol was performed in a seating position.
  
        Blood samples were taken from fingertips by skilled technicians to 20 uL capillary tubes. bLa
        was measured with Super GL2 analyzer (Dr. Müller Gerätebau GmbH, Freital, Germany).
  
        Whereas participants and data collectors were aware of the allocated training method, the
        laboratory technicians performing biochemistry assays were kept blinded to the allocation.
        The participants were assigned at random to either E or C group to perform VIH protocol under
        a supervision of qualified physiotherapist.
  
        Stratified randomization to assign the participants was used. First, the participants were
        assigned to subgroups based on the membership in National Development or National Elite Team.
        Then, the participants were assigned to subgroups based on the gender. Then, the participants
        were assigned to E or C group based on the coin toss.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Group Randomized Controlled Trial
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Changes in blood lactate (bLa)
  time frame: 30 minutes
  description: The blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure the bLa.
  Blood samples were taken from fingertips by skilled technicians to 20 uL capillary tubes. bLa was measured with Super GL2 analyzer (Dr. Müller Gerätebau GmbH, Freital, Germany).
  measure: Changes in rate of perceived exertion (RPE)
  time frame: 30 minutes
  description: The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes after cessation of the exercise to measure the rate of perceived exertion (RPE) (Borg, 1998).
  arm group label: Experimental
  arm group type: Experimental
  arm group label: Control
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Voluntary Isocapnic Hyperpnea
  description: The protocol of 3' of breathing with 20 breaths·min-1 frequency. The Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc, Kelowna, Canada) with 6-liter bags were used. The protocol was performed in a seating position.
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Poland
  responsible party type: Principal Investigator
  investigator affiliation: Institute of Sport - National Research Institute, Poland
  investigator full name: Tomasz Kowalski
  investigator title: Principal Investigator
  sharing ipd: Yes
  ipd description: Upon reasonable request.