<?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>IRCT20221102056381N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-24</date_registration>
      <primary_sponsor>Shahrekord University</primary_sponsor>
      <public_title>Comparison of the effect of exercise training on bone metabolism in adolescent boy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of 12 weeks of plyometric and HICT training on serum levels of  FGF23, KLOTHO, and Some markers related to bone metabolism in adolescent boy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>63</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66701</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: To reduce the influence of maturity, and to maximize the balance and homogenization of the groups, 63 selected subjects of this research (selected based on the inclusion criteria) were also examined in terms of biological maturity status. Considering the importance of biological maturity in the present research and with the aim of relatively balanced distribution of the subjects in groups, first we stratified the subjects based on the status of biological maturity and using the age of peak height velocity (aPHV) formula.
Random allocation software is also used for randomization. In addition to simple randomization, these random sequence generation softwares are capable of generating a random sequence using the block method,that from each block, three subjects were placed in the control group, three subjects in the intervention group 1, and three subjects in the intervention group 2, so that the number of subjects Each group reached 21 people.The advantage of this method is that the distribution of the subjects is done in a more balanced and favorable manner, and it will not be the case that most of the subjects of one group have a significantly higher biological age than other groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bone Density.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: HICT exercise protocol is performed three days a week for 12 weeks. The intensity of the exercises will be gradually increased by using the methods of increasing the training pressure. Intervention 2: Intervention group 2: plyometric exercise protocol is performed three days a week for 12 weeks. The intensity of the exercises will be gradually increased by using the methods of increasing the training pressure. Intervention 3: Control group: They do not receive any kind of training.</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>Reyhane Shokoohi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Sport Sciences, Shahrekord University, Shahrekord, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8818634141</zip>
        <telephone>+98 38 3232 4407</telephone>
        <email>r.shokoohi2008@yahoo.com</email>
        <affiliation>Shahrekord University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akbar Azamian Jazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Sport Sciences, Shahrekord University, Shahrekord, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8818634141</zip>
        <telephone>+98 38 3232 4407</telephone>
        <email>Azaminakbar@yahoo.com</email>
        <affiliation>Shahrekord University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male teenagers 
Aged 13-15 years</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Any type of disease such as anemia, obesity, diabetes, heart disease
Using any type of special medicine
Participating in regular sports activities in the last 6 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>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: HICT exercise protocol is performed three days a week for 12 weeks. The intensity of the exercises will be gradually increased by using the methods of increasing the training pressure.</i_keyword>
      <i_keyword>Intervention group 2: plyometric exercise protocol is performed three days a week for 12 weeks. The intensity of the exercises will be gradually increased by using the methods of increasing the training pressure.</i_keyword>
      <i_keyword>Control group: They do not receive any kind of training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of FGF23. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: Eliza kit (BioSwamp Company, NY, USA).</prim_outcome>
      <prim_outcome>Serum level of αKlotho. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: Using the ELISA kit.</prim_outcome>
      <prim_outcome>Serum level of GH. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: radium kit.</prim_outcome>
      <prim_outcome>SERUM LEVEL OF IGF-1. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: DRG IGF-11600 enzyme immunoassay kit.</prim_outcome>
      <prim_outcome>BMD. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: Dual-energy X-ray absorptiometry (DEXA).</prim_outcome>
      <prim_outcome>BMC. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: Dual-energy X-ray absorptiometry (DEXA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>SERUM LEVEL OF CALSITERIOL. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: ELISA TEST.</sec_outcome>
      <sec_outcome>SERUN LEVEL OF PHOSPHATE. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: ELISA TEST.</sec_outcome>
      <sec_outcome>SERUM LEVEL OF CALSIUM. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: ELISA TEST.</sec_outcome>
      <sec_outcome>Serum level of PHEX. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: ELISA TEST.</sec_outcome>
      <sec_outcome>Serun level of PTH. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: ELISA TEST.</sec_outcome>
      <sec_outcome>SeruM level of vitamin D. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: Elisa test.</sec_outcome>
      <sec_outcome>Serum level of DMP1. Timepoint: Before and after 12 weeks of plyometric and HICT training. Method of measurement: Elisa test.</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>Shahrekord University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-30</approval_date>
        <contact_name>Ethics Committee of Shahrekord University</contact_name>
        <contact_address>Shahrekord University, Shahrekord, Iran Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
