<?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>IRCT20180503039517N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-16</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effect of a resistance training course with and without blood flow restriction on the plasma level of some blood enzymatic and inflammation indicators and body composition of beginner bodybuilders</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of a resistance training course with and without blood flow restriction on the plasma level of some blood enzymatic and inflammation indicators and body composition of beginner bodybuilders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>1399-11-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53713</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: 40 male bodybuilders will be selected by available sampling method.
  Through lottery (participants' names were written on paper and will be divided into experimental and control groups through random lottery), Blinding description: In this research, participants are unaware of the group assigned to themselves and other participants. A separate workout hour is considered for each intervention group.
The person in charge of collecting data and the processor are also unaware of the type of intervention and the people involved in the research groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The use of Katsu in bodybuilding exercises and its effect on blood biochemical factors.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The resistance training group will train with Katsu, three sessions per week and 90 minutes per session. The method of doing the exercises is that at the beginning of each session, warm-up is done for 10 minutes with soft running and stretching movements. Next, the main exercises are performed with low intensity, ie with an intensity of 25 to 30% 1RM, which is closed on the upper part of the limb during the tourniquet exercises. The desired pressure for the tourniquet is set at 100 mm Hg, which, according to research, reduces blood flow by half. Intervention 2: Control group: Including traditional resistance exercises with an intensity of 70 to 75% 1RM for 90 minutes and for each rest period between sets 1 minute and between movement 2 minutes, warm-up 10 minutes and cooling 5 minutes was considered. Forearm exercises with dumbbells (pair of hands), lath, back of thighs, front of thighs, leg with machine, foot press, foot splint, squat with barbell, back of arm with demil (pair of hands), barbell head from front and back (Smith) , Forearm with barbell, dumbbell forearm sitting single-handed. Each is in 10 sets of 10 repetitions.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soleyman Ansari Kolachahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>second floor, Adibsaber Apartment, next to Esparo restaurant, Prof. Samei Blv.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193193933</zip>
        <telephone>+98 13 3375 2906</telephone>
        <email>solomonansari@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soleyman Ansari Kolachahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>second floor, Adibsaber Apartment, next to Esparo restaurant, Prof. Samei Blv.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193193933</zip>
        <telephone>+98 13 3375 2906</telephone>
        <email>solomonansari@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age (19-29 years)
Gender (male)
A maximum of 3 months involving  resistance exercise</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>29 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>smoking
Having cardiorespiratory, musculoskeletal, neurological, hormonal or orthopedic disorders
No ingestion of androgenic and energetic supplements in the past 1 months</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The resistance training group will train with Katsu, three sessions per week and 90 minutes per session. The method of doing the exercises is that at the beginning of each session, warm-up is done for 10 minutes with soft running and stretching movements. Next, the main exercises are performed with low intensity, ie with an intensity of 25 to 30% 1RM, which is closed on the upper part of the limb during the tourniquet exercises. The desired pressure for the tourniquet is set at 100 mm Hg, which, according to research, reduces blood flow by half.</i_keyword>
      <i_keyword>Control group: Including traditional resistance exercises with an intensity of 70 to 75% 1RM for 90 minutes and for each rest period between sets 1 minute and between movement 2 minutes, warm-up 10 minutes and cooling 5 minutes was considered. Forearm exercises with dumbbells (pair of hands), lath, back of thighs, front of thighs, leg with machine, foot press, foot splint, squat with barbell, back of arm with demil (pair of hands), barbell head from front and back (Smith) , Forearm with barbell, dumbbell forearm sitting single-handed. Each is in 10 sets of 10 repetitions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Levels of muscle enzymes (CK, LDH). Timepoint: 48 hours before and after the exercise intervention. Method of measurement: For 12 hours, fasting will be performed as a sample of arm venous blood with the help of a 5 ml syringe, sitting on a chair.</prim_outcome>
      <prim_outcome>Inflammatory markers (C-reactive protein, interleukin-6). Timepoint: 48 hours before and after the exercise intervention. Method of measurement: For 12 hours, fasting will be performed as a sample of arm venous blood with the help of a 5 ml syringe, sitting on a chair.</prim_outcome>
      <prim_outcome>Hematological indicators of blood (white and red blood cells and platelets). Timepoint: 48 hours before and after the exercise intervention. Method of measurement: For 12 hours, fasting will be performed as a sample of arm venous blood with the help of a 5 ml syringe, sitting on a chair.</prim_outcome>
      <prim_outcome>Some factors of physical fitness (strength, body composition). Timepoint: 48 hours before and after the exercise intervention. Method of measurement: For 12 hours, fasting will be performed as a sample of arm venous blood with the help of a 5 ml syringe, sitting on a chair.</prim_outcome>
      <prim_outcome>Growth hormones, cortisol, testosterone. Timepoint: 48 hours before and after the exercise intervention. Method of measurement: For 12 hours, fasting will be performed as a sample of arm venous blood with the help of a 5 ml syringe, sitting on a chair.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-23</approval_date>
        <contact_name>The ethics committee of Islamic Azad University, Rasht Branch</contact_name>
        <contact_address>Islamic Azad University, Rasht Branch, Lakan Blv Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
