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/NCT05982665</url>
    </required_header>
    <id_info>
      <org_study_id>FTK_2023_12</org_study_id>
      <nct_id>NCT05982665</nct_id>
    </id_info>
    <brief_title>Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill</brief_title>
    <official_title>Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill. A Randomized, Double-blind, Placebo-controlled Crossover Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Palacky University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Palacky University</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>
        This study assesses the effect of molecular hydrogen inhalation in healthy males on muscle&#xD;
        soreness, fatigue, oxidative stress, and inflammation following eccentric muscle contraction&#xD;
        during downhill walking on the treadmill.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main aim of this randomized, double-blind, placebo-controlled crossover study is to&#xD;
        assess the effect of molecular hydrogen inhalation on recovery after downhill walking with an&#xD;
        additional load of 15% of body mass on the treadmill with a negative slope of -15% at a speed&#xD;
        of 6.5 km/h for 90 min. The study includes 12 participants, healthy males aged 20-35 years.&#xD;
        The study consists of two experimental sessions, one using molecular hydrogen inhalation and&#xD;
        the other using placebo inhalation. Randomization is performed using a computer random&#xD;
        generator. Molecular hydrogen is colourless, odourless, and tasteless, so it cannot be&#xD;
        distinguished from placebo by the human senses. The washout period between sessions is set at&#xD;
        four weeks. One week before each session, participants are asked to follow diet and physical&#xD;
        activity rules. Variables measured during the 48 h recovery are as follow: creatine kinase&#xD;
        level, perceived muscle soreness, reactive strength index, malondialdehydes level, and&#xD;
        interleukin-6 level. The following variables are also measured during exercise: heart rate,&#xD;
        ventilation and gas exchange, and blood lactate level. Analysis of variance for repeated&#xD;
        measures and Fisher's post hoc tests are used for statistical analysis. The significance&#xD;
        level is set at 0.05.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 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>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Hydrogen and placebo generators indistinguishable to the human senses</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Creatine kinase</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>The level of creatine kinase is measured from a venous blood sample taken by a healthcare specialist. Samples are collected in 2.7 ml citrate vacuum tubes. Samples are immediately centrifuged at 1000 g for 15 min and then divided into 0.5 ml cryotubes and frozen at -80 °C. Samples are taken pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise. Creatine kinase is determined by ELISA method according to the manufacturer's instructions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived muscle soreness</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>A visual analogue scale is used to subjectively assess lower limb muscle soreness. The visual analogue scale is represented by a 100 mm line marked 0 - no pain and 100 - worst imaginable pain. The subject is instructed to mark a point on the line corresponding to their perceived muscle soreness. Muscle soreness is assessed pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reactive strength index</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>Reactive strength index is determined in 5 maximum hop test on AMTI OR6-7-1000 force platform (Advanced Mechanical Technology, Watertown, USA). Each subject is instructed to maximize the jump height and minimize the ground contact time. Reactive strength index is measured pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Malondialdehydes</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>The level of malondialdehydes is measured from a venous blood sample taken by a healthcare specialist. Samples are collected in 2.7 ml citrate vacuum tubes. Samples are immediately centrifuged at 1000 g for 15 min and then divided into 0.5 ml cryotubes and frozen at -80 °C. Samples are taken pre-exercise (baseline), post-exercise, and 2 h post-exercise. Malondialdehydes are determined using TBARS assay kit according to the manufacturer's instructions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin-6</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>The level of Interleukin-6 is measured from a venous blood sample taken by a healthcare specialist. Samples are collected in 2.7 ml citrate vacuum tubes. Samples are immediately centrifuged at 1000 g for 15 min and then divided into 0.5 ml cryotubes and frozen at -80 °C. Samples are taken pre-exercise (baseline), post-exercise, and 2 h post-exercise. Interleukin-6 is determined by ELISA method according to the manufacturer's instructions.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Heart rate</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>Heart rate during the 90 min exercise is continuously recorded by Polar V800 heart rate monitor (Polar, Kempele, Finland).</description>
    </other_outcome>
    <other_outcome>
      <measure>Ventilation</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>Ventilation (air flow into and out of the lungs expressed in L/min) is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise and averaged over 5 min windows for subsequent analysis.</description>
    </other_outcome>
    <other_outcome>
      <measure>Oxygen uptake</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>Oxygen uptake is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise and averaged over 5 min windows for subsequent analysis.</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood lactate</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>The level of blood lactate is measured from the fingertip blood sample using Lactate Scout+ analyser (EKF Diagnostics, Cardiff, UK) pre-exercise (baseline) and at specified time points (30, 60, and 90 min) during the exercise.</description>
    </other_outcome>
    <other_outcome>
      <measure>Rating of perceived exertion</measure>
      <time_frame>Change between values before and after 4 weeks of crossover.</time_frame>
      <description>Subjects are asked to subjectively rate their perceived exertion at specified time points (30, 60, and 90 min) during the exercise. The Borg's scale 6 (no exertion at all) and 20 (maximal exertion) is used.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Muscle Soreness</condition>
    <condition>Muscle Fatigue</condition>
    <condition>Oxidative Stress</condition>
    <condition>Inflammation</condition>
    <arm_group>
      <arm_group_label>Molecular hydrogen</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Molecular hydrogen inhalation for 60 min at 48 h, 24 h, and 60 min pre-exercise and for 30 min post-exercise and 24 h post exercise.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo inhalation for 60 min at 48 h, 24 h, and 60 min pre-exercise and for 30 min post-exercise and 24 h post exercise.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Molecular hydrogen</intervention_name>
      <description>Hydrogen gas, purity &gt;99.9%, flow rate 300 ml/min.</description>
      <arm_group_label>Molecular hydrogen</arm_group_label>
      <other_name>i300 Hydrogen Generator, H2 World Health &amp; Beauty Company, Ostrava, Czech Republic</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Ambient air, flow rate 300 ml/min.</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>i300 Placebo Generator, H2 World Health &amp; Beauty Company, Ostrava, Czech Republic</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Free of major diseases.&#xD;
  &#xD;
            -  Completed questionnaire Sudden Cardiovascular Death in Sport: Lausanne&#xD;
               Recommendations.&#xD;
  &#xD;
            -  Signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute conditions contraindicating laboratory testing of sports performance.&#xD;
  &#xD;
            -  Hypertension.&#xD;
  &#xD;
            -  Dyslipoproteinaemia.&#xD;
  &#xD;
            -  Cardiorespiratory disease.&#xD;
  &#xD;
            -  Pharmacotherapy affecting heart rate.&#xD;
  &#xD;
            -  Musculoskeletal problems.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Adam Jarmar, Mgr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Palacky University, Faculty of Physical Culture</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Palacky University, Faculty of Physical Culture</name>
        <address>
          <city>Olomouc</city>
          <zip>77111</zip>
          <country>Czechia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Palacky University</investigator_affiliation>
      <investigator_full_name>Jakub Krejci</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myalgia</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Anonymised raw data will be made available.</ipd_description>
      <ipd_time_frame>The data will be available once the results are published in a scientific journal.</ipd_time_frame>
      <ipd_access_criteria>For everybody.</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/NCT05982665
  org study id: FTK_2023_12
  nct id: NCT05982665
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study assesses the effect of molecular hydrogen inhalation in healthy males on muscle
        soreness, fatigue, oxidative stress, and inflammation following eccentric muscle contraction
        during downhill walking on the treadmill.
  The main aim of this randomized, double-blind, placebo-controlled crossover study is to
        assess the effect of molecular hydrogen inhalation on recovery after downhill walking with an
        additional load of 15% of body mass on the treadmill with a negative slope of -15% at a speed
        of 6.5 km/h for 90 min. The study includes 12 participants, healthy males aged 20-35 years.
        The study consists of two experimental sessions, one using molecular hydrogen inhalation and
        the other using placebo inhalation. Randomization is performed using a computer random
        generator. Molecular hydrogen is colourless, odourless, and tasteless, so it cannot be
        distinguished from placebo by the human senses. The washout period between sessions is set at
        four weeks. One week before each session, participants are asked to follow diet and physical
        activity rules. Variables measured during the 48 h recovery are as follow: creatine kinase
        level, perceived muscle soreness, reactive strength index, malondialdehydes level, and
        interleukin-6 level. The following variables are also measured during exercise: heart rate,
        ventilation and gas exchange, and blood lactate level. Analysis of variance for repeated
        measures and Fisher's post hoc tests are used for statistical analysis. The significance
        level is set at 0.05.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  masking description: Hydrogen and placebo generators indistinguishable to the human senses
  measure: Creatine kinase
  time frame: Change between values before and after 4 weeks of crossover.
  description: The level of creatine kinase is measured from a venous blood sample taken by a healthcare specialist. Samples are collected in 2.7 ml citrate vacuum tubes. Samples are immediately centrifuged at 1000 g for 15 min and then divided into 0.5 ml cryotubes and frozen at -80 °C. Samples are taken pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise. Creatine kinase is determined by ELISA method according to the manufacturer's instructions.
  measure: Perceived muscle soreness
  time frame: Change between values before and after 4 weeks of crossover.
  description: A visual analogue scale is used to subjectively assess lower limb muscle soreness. The visual analogue scale is represented by a 100 mm line marked 0 - no pain and 100 - worst imaginable pain. The subject is instructed to mark a point on the line corresponding to their perceived muscle soreness. Muscle soreness is assessed pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise.
  measure: Reactive strength index
  time frame: Change between values before and after 4 weeks of crossover.
  description: Reactive strength index is determined in 5 maximum hop test on AMTI OR6-7-1000 force platform (Advanced Mechanical Technology, Watertown, USA). Each subject is instructed to maximize the jump height and minimize the ground contact time. Reactive strength index is measured pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise.
  measure: Malondialdehydes
  time frame: Change between values before and after 4 weeks of crossover.
  description: The level of malondialdehydes is measured from a venous blood sample taken by a healthcare specialist. Samples are collected in 2.7 ml citrate vacuum tubes. Samples are immediately centrifuged at 1000 g for 15 min and then divided into 0.5 ml cryotubes and frozen at -80 °C. Samples are taken pre-exercise (baseline), post-exercise, and 2 h post-exercise. Malondialdehydes are determined using TBARS assay kit according to the manufacturer's instructions.
  measure: Interleukin-6
  time frame: Change between values before and after 4 weeks of crossover.
  description: The level of Interleukin-6 is measured from a venous blood sample taken by a healthcare specialist. Samples are collected in 2.7 ml citrate vacuum tubes. Samples are immediately centrifuged at 1000 g for 15 min and then divided into 0.5 ml cryotubes and frozen at -80 °C. Samples are taken pre-exercise (baseline), post-exercise, and 2 h post-exercise. Interleukin-6 is determined by ELISA method according to the manufacturer's instructions.
  measure: Heart rate
  time frame: Change between values before and after 4 weeks of crossover.
  description: Heart rate during the 90 min exercise is continuously recorded by Polar V800 heart rate monitor (Polar, Kempele, Finland).
  measure: Ventilation
  time frame: Change between values before and after 4 weeks of crossover.
  description: Ventilation (air flow into and out of the lungs expressed in L/min) is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise and averaged over 5 min windows for subsequent analysis.
  measure: Oxygen uptake
  time frame: Change between values before and after 4 weeks of crossover.
  description: Oxygen uptake is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise and averaged over 5 min windows for subsequent analysis.
  measure: Blood lactate
  time frame: Change between values before and after 4 weeks of crossover.
  description: The level of blood lactate is measured from the fingertip blood sample using Lactate Scout+ analyser (EKF Diagnostics, Cardiff, UK) pre-exercise (baseline) and at specified time points (30, 60, and 90 min) during the exercise.
  measure: Rating of perceived exertion
  time frame: Change between values before and after 4 weeks of crossover.
  description: Subjects are asked to subjectively rate their perceived exertion at specified time points (30, 60, and 90 min) during the exercise. The Borg's scale 6 (no exertion at all) and 20 (maximal exertion) is used.
  arm group label: Molecular hydrogen
  arm group type: Experimental
  description: Molecular hydrogen inhalation for 60 min at 48 h, 24 h, and 60 min pre-exercise and for 30 min post-exercise and 24 h post exercise.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo inhalation for 60 min at 48 h, 24 h, and 60 min pre-exercise and for 30 min post-exercise and 24 h post exercise.
  intervention type: Other
  intervention name: Molecular hydrogen
  description: Hydrogen gas, purity >99.9%, flow rate 300 ml/min.
  arm group label: Molecular hydrogen
  other name: i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
  intervention type: Other
  intervention name: Placebo
  description: Ambient air, flow rate 300 ml/min.
  arm group label: Placebo
  other name: i300 Placebo Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
  criteria: 
  gender: Male
  minimum age: 20 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Adam Jarmar, Mgr
  role: Principal Investigator
  affiliation: Palacky University, Faculty of Physical Culture
  facility: 
  country: Czechia
  responsible party type: Principal Investigator
  investigator affiliation: Palacky University
  investigator full name: Jakub Krejci
  investigator title: Assistant professor
  mesh term: Myalgia
  mesh term: Inflammation
  sharing ipd: Yes
  ipd description: Anonymised raw data will be made available.
  ipd time frame: The data will be available once the results are published in a scientific journal.
  ipd access criteria: For everybody.