<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190720044283N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-23</date_registration>
      <primary_sponsor>University of Guilan</primary_sponsor>
      <public_title>Effect of sodium bicarbonate on anaerobic capacity under hypoxia and normoxia</public_title>
      <acronym></acronym>
      <scientific_title>The acute effect of pre-anaerobic workout sodium bicarbonate intake on heart rate, heart rate variability, rating perceived exertion and anaerobic power of male athletes under hypoxic and normoxic conditions</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59467</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Other, Randomization description: Use the random selection method by Excel software.
In this method, we first enter the names of the subjects in Excel, and then in another part, we specify the position of the desired groups in two separate sections of 6 subjects. Then in these two sections, we will execute the following code so that people are randomly placed in groups of 6 subjects.
=INDEX($A$3:$A$12,RANDBETWEEN(1,ROWS($A$3:$A$12)),1), Blinding description: In this study, the subjects were not aware of how the supplement or placebo was distributed. The G-physician was aware of the subjects receiving the supplement to take action if any possible allergies to the supplement occurred. Then, the physician weighed the supplement and placebo using the determined amount per weight of each subject and delivered it to the subjects for consumption in his presence by coding on each day of the test.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Muscle fatigue during exercise activity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Subjects will consume 0.3 grams of sodium bicarbonate per kilogram of body weight one hour before the start of the activity. After the initial measurements and warm-up, the anaerobic activity of the Wingate will be performed by the Monark cycle ergometer and by a training mask (Phantom Athletics 001 model) in hypoxic conditions. The test process will take 9 minutes and then 30 minutes at rest (sitting) the desired variables will be monitored. Intervention 2: Intervention group: Subjects will consume 0.3 grams of sodium bicarbonate per kilogram of body weight one hour before exercise. After the initial measurements and warm-up, the anaerobic activity of the Wingate will be performed by the Monark cycle ergometer under normoxic conditions and without a mask. The test process will take 9 minutes and then 30 minutes at rest (sitting) the desired variables will be monitored. Intervention 3: Control group: Subjects will receive the same amount of placebo, which contains dextrose. After the initial measurements and warm-up, the anaerobic activity of the Wingate will be performed by the Monark cycle ergometer and by a training mask (Phantom Athletics 001 model) in hypoxic conditions. The test process will take 9 minutes and then 30 minutes at rest (sitting) the desired variables will be monitored. Intervention 4: Control group: Subjects will receive the same amount of placebo, which contains dextrose. After the initial measurements and warm-up, the anaerobic bouts of the Wingate will be performed by the Monark cycle ergometer under normoxic conditions and without a mask. The test process will take 9 minutes and then 30 minutes at rest (sitting) the desired variables will be monitored.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The data release schedule is not yet known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Javad Mehrabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8 km of Tehran road, Faculty of Physical Education and Sports Sciences, University of Guilan</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199843653</zip>
        <telephone>+98 911 230 9074</telephone>
        <email>mehrabanij@guilan.ac.ir</email>
        <affiliation>Faculty of Physical Education and Sports Sciences, University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Javad Mehrabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8 km of Tehran road, Faculty of Physical Education and Sports Sciences, University of Guilan</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199843653</zip>
        <telephone>+98 911 230 9074</telephone>
        <email>mehrabanij@guilan.ac.ir</email>
        <affiliation>Faculty of Physical Education and Sports Sciences, University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Physical health and with no disease
No medication and exercise supplements 6 months before the test
No smoking and alcohol consumption
Have regular exercise 3 days a week for the past year
Age range 18 to 25 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Inability to perform intense anaerobic activity
Sensitivity to sodium bicarbonate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Subjects will consume 0.3 grams of sodium bicarbonate per kilogram of body weight one hour before the start of the activity. After the initial measurements and warm-up, the anaerobic activity of the Wingate will be performed by the Monark cycle ergometer and by a training mask (Phantom Athletics 001 model) in hypoxic conditions. The test process will take 9 minutes and then 30 minutes at rest (sitting) the desired variables will be monitored.</i_keyword>
      <i_keyword>Intervention group: Subjects will consume 0.3 grams of sodium bicarbonate per kilogram of body weight one hour before exercise. After the initial measurements and warm-up, the anaerobic activity of the Wingate will be performed by the Monark cycle ergometer under normoxic conditions and without a mask. The test process will take 9 minutes and then 30 minutes at rest (sitting) the desired variables will be monitored.</i_keyword>
      <i_keyword>Control group: Subjects will receive the same amount of placebo, which contains dextrose. After the initial measurements and warm-up, the anaerobic activity of the Wingate will be performed by the Monark cycle ergometer and by a training mask (Phantom Athletics 001 model) in hypoxic conditions. The test process will take 9 minutes and then 30 minutes at rest (sitting) the desired variables will be monitored.</i_keyword>
      <i_keyword>Control group: Subjects will receive the same amount of placebo, which contains dextrose. After the initial measurements and warm-up, the anaerobic bouts of the Wingate will be performed by the Monark cycle ergometer under normoxic conditions and without a mask. The test process will take 9 minutes and then 30 minutes at rest (sitting) the desired variables will be monitored.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate variability. Timepoint: Before and immediately after the activity in the period of 10 minutes to 30 minutes after the activity. Method of measurement: Polar heart rate monitor (H10).</prim_outcome>
      <prim_outcome>Muscle Power. Timepoint: Before supplementation and at each point of the fatigue protocol and after completion of the activity. Method of measurement: Monark ergometer cycle and by Wingate protocol.</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: Before and immediately after the activity in the period of 10 minutes to 30 minutes after the activity. Method of measurement: Beurer blood pressure monitor.</prim_outcome>
      <prim_outcome>Rate of Perceived Exertion (RPE). Timepoint: Immediately after each bout. Method of measurement: Borg scale (6-20).</prim_outcome>
      <prim_outcome>Muscle Pain. Timepoint: Immediately after each bout. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-22</approval_date>
        <contact_name>Research Ethics Committee of Sports Science Institute (SSRI)</contact_name>
        <contact_address>Fifth Alley, Mir Emad St., Ostad Motahhari St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
