<?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>IRCT20180712040448N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-01</date_registration>
      <primary_sponsor>Islamic Azad University Aliabad Katoul Branch</primary_sponsor>
      <public_title>The effect of physical exercises on TSH, GH, body composition indices and cognitive functions</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of resistance and aerobic trainings on serum levels of TSH and GH, body composition and cognitive functions indexes in adolescents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>600</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68503</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants were selected by stratified randommization and will be divided into research groups.
Randomization Unit: Individual
Randomization tool: Table of Morgan random numbers table
The participants will be divided into boy and girl groups and then into active and inactive groups.
Then they will be placed in the following groups: aerobic exercise, resistance exercise and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Examining changes in TSH  hormone. Condition 2: Examining changes in  GH hormone. Condition 3: Examining changes in  body composition indices. Condition 4: Examining changes in  cognitive function.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Resistance training: Each participant’s 6 repetition maximum (6 RM) will use to estimate their 1 RM using the Brzycki formula (%1RM = 102.78–2.78 * repetitions). This will use to determine the load corresponding to the prescribed intensity (% of 1RM) for the first week of training. The resistance training program will inform by accepted guidelines for resistance training in youth and involved a twice a week progressive periodized program including a variety of exercises for all major muscle groups using resistance machine exercises and free weights (bars and dumbbells), medicine balls, Bosu and Swiss balls. Participants perform between 2 and 4 sets of an exercise with between 30–120 seconds rest between sets. Overall, intensity will increase across the 16 weeks such that during weeks 1–5; 16–20 RM with 30 seconds rest between sets, in weeks 6–10; between 8–14 RM, with between 30–120 seconds inter-set rest, and in weeks 11–16; between 6 and 12 RM with 30–120 seconds inter-set rest. Intervention 2: Intervention group: Aerobic training: The intensity of the sessions was progressively will increase from moderate to vigorous across the course of the intervention. In order to determine the HR range which corresponded to the prescribed intensity, we will estimate maximum heart rate according to the Astrand’s formula (HR max = 216.6 –(0.84 x age)). Intensity and duration will progresse across the 16-week program as follows: weeks 1–3; 20 minutes at 65–75% of estimated max HR; weeks 4–6; 30 mins at 65–75%, weeks 7–12; 30 minutes at 70–80%, weeks 13–16; 35 minutes at 70–80%. The principal activities will use in aerobic are variations in straight line and multi directional jogging/running, with obstacles such as cones, hoops and speed ladders. Sessions also include step aerobics and sports orientated sessions incorporating balls. Intervention 3: Control group: They received no intervention without any lifestyle changes.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All information except statistical data; It can be shared after de-identifying the participants.

When:
The access period starts 6 months after the results are published

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Teaching how to sample, randomize, implement the protocol and use tools and tests

Where to obtain:
Dr. reza Rezaeeshirazi
Dr.Rezaee@aliabadiau.ac.ir

How to obtain:
The applicant will receive the desired answer two weeks after submitting her/his application via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Rezaeeshirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Aliabad Katul City - University Blvd</address>
        <city>Aliabad Katoul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4941793451</zip>
        <telephone>+98 17 3422 2300</telephone>
        <email>Dr.Rezaee@aliabadiau.ac.ir</email>
        <affiliation>Islamic Azad University Aliabad Katoul Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Rezaeeshirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Aliabad Katul City - University Blvd</address>
        <city>Aliabad Katoul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4941793451</zip>
        <telephone>+98 17 3422 2300</telephone>
        <email>Dr.Rezaee@aliabadiau.ac.ir</email>
        <affiliation>Islamic Azad University Aliabad Katoul Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being between 11 and 15 years old
Studying in one of the first secondary schools of Aliabad Katul city
Consent of the family for their child's participation in the trial
Ability to participate in physical exercises</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking a specific drug
Suffering from specific physical or mental diseases
Drug abuse
lack of education</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E22.9</hc_code>
      <hc_code>E22.9</hc_code>
      <hc_code>E66.09</hc_code>
      <hc_code>F99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hyperfunction of pituitary gland, unspecified</hc_keyword>
      <hc_keyword>Hyperfunction of pituitary gland, unspecified</hc_keyword>
      <hc_keyword>Other obesity due to excess calories</hc_keyword>
      <hc_keyword>Mental disorder, not otherwise specified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Resistance training: Each participant’s 6 repetition maximum (6 RM) will use to estimate their 1 RM using the Brzycki formula (%1RM = 102.78–2.78 * repetitions). This will use to determine the load corresponding to the prescribed intensity (% of 1RM) for the first week of training. The resistance training program will inform by accepted guidelines for resistance training in youth and involved a twice a week progressive periodized program including a variety of exercises for all major muscle groups using resistance machine exercises and free weights (bars and dumbbells), medicine balls, Bosu and Swiss balls. Participants perform between 2 and 4 sets of an exercise with between 30–120 seconds rest between sets. Overall, intensity will increase across the 16 weeks such that during weeks 1–5; 16–20 RM with 30 seconds rest between sets, in weeks 6–10; between 8–14 RM, with between 30–120 seconds inter-set rest, and in weeks 11–16; between 6 and 12 RM with 30–120 seconds inter-set rest.</i_keyword>
      <i_keyword>Intervention group: Aerobic training: The intensity of the sessions was progressively will increase from moderate to vigorous across the course of the intervention. In order to determine the HR range which corresponded to the prescribed intensity, we will estimate maximum heart rate according to the Astrand’s formula (HR max = 216.6 –(0.84 x age)). Intensity and duration will progresse across the 16-week program as follows: weeks 1–3; 20 minutes at 65–75% of estimated max HR; weeks 4–6; 30 mins at 65–75%, weeks 7–12; 30 minutes at 70–80%, weeks 13–16; 35 minutes at 70–80%. The principal activities will use in aerobic are variations in straight line and multi directional jogging/running, with obstacles such as cones, hoops and speed ladders. Sessions also include step aerobics and sports orientated sessions incorporating balls.</i_keyword>
      <i_keyword>Control group: They received no intervention without any lifestyle changes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TSH blood levels. Timepoint: Measurement of TSH blood levels at the beginning of the second phase study (before the start of the intervention) and 16 weeks later. Method of measurement: laboratory kit.</prim_outcome>
      <prim_outcome>GH blood levels. Timepoint: Measurement of GH blood levels at the beginning of the second phase study (before the start of the intervention) and 16 weeks later. Method of measurement: laboratory kit.</prim_outcome>
      <prim_outcome>BMI. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: BMI Formula.</prim_outcome>
      <prim_outcome>Short term working memory. Timepoint: At the beginning of the first phase of the study, the beginning of the second phase of the study and its end. Method of measurement: digit span forward test.</prim_outcome>
      <prim_outcome>Amount of daily physical activity. Timepoint: At the beginning of the first phase of the study. Method of measurement: International Physical Activity Questionnaire (IPAQ) – Long Form.</prim_outcome>
      <prim_outcome>Body fat percentage. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: Jackson-Pollock Formula.</prim_outcome>
      <prim_outcome>Lean body mass percentage. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: Jackson Pollock's complementary formula.</prim_outcome>
      <prim_outcome>Processing speed. Timepoint: At the beginning of the first phase of the study, the beginning of the second phase of the study and its end. Method of measurement: digit-symbol coding test.</prim_outcome>
      <prim_outcome>Reaction time. Timepoint: At the beginning of the first phase of the study, the beginning of the second phase of the study and its end. Method of measurement: computer modified Stroop color-word test.</prim_outcome>
      <prim_outcome>Error number. Timepoint: At the beginning of the first phase of the study, the beginning of the second phase of the study and its end. Method of measurement: computer modified Stroop color-word test.</prim_outcome>
      <prim_outcome>Body fat mass. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: FM  formula.</prim_outcome>
      <prim_outcome>Fat-free body mass. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: PFFM  formula.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: tape measure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lipid profile. Timepoint: At the beginning of the second phase the study (before the start of the intervention) and 16 weeks later. Method of measurement: laboratory kit.</sec_outcome>
      <sec_outcome>Glucose. Timepoint: At the beginning of the second phase the study (before the start of the intervention) and 16 weeks later. Method of measurement: laboratory kit.</sec_outcome>
      <sec_outcome>Height. Timepoint: At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end. Method of measurement: tape measure.</sec_outcome>
      <sec_outcome>Weight. Timepoint: At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end. Method of measurement: digital Balance.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Muscle strength. Timepoint: At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end. Method of measurement: 1 RM Formula.</sec_outcome>
      <sec_outcome>Aerobic power. Timepoint: At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end. Method of measurement: submaximal treadmill test.</sec_outcome>
      <sec_outcome>Personality measurement. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: Eysenck Eysenck Personality Questionnaire (JEPQ) Questionnaire (JEPQ).</sec_outcome>
      <sec_outcome>Academic motivation. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: Harter's standard academic motivation questionnaire.</sec_outcome>
      <sec_outcome>Moods. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: Brunel Mood Scale Questionnaire.</sec_outcome>
      <sec_outcome>General Health. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: General Health Questionare (GHQ-28).</sec_outcome>
      <sec_outcome>Internet Addiction. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: Young's Internet Addiction Questionnaire.</sec_outcome>
      <sec_outcome>Appetite. Timepoint: At the beginning of the first phase of the study and its end. Method of measurement: Adolescent Food Habits Checklist (Johnson &amp; et al).</sec_outcome>
      <sec_outcome>Complete Blood count (CBC). Timepoint: At the beginning of the second phase the study (before the start of the intervention) and 16 weeks later. Method of measurement: Fluorescece Flow Cytometry.</sec_outcome>
      <sec_outcome>Speed. Timepoint: At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end. Method of measurement: 60 yard test.</sec_outcome>
      <sec_outcome>Legs explosive power. Timepoint: At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end. Method of measurement: Sargent Jump Test.</sec_outcome>
      <sec_outcome>Hands explosive power. Timepoint: At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end. Method of measurement: Medicine ball throw.</sec_outcome>
      <sec_outcome>Agility. Timepoint: At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end. Method of measurement: T 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>Islamic Azad University Aliabad Katoul Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-08</approval_date>
        <contact_name>Ethics committee of Islamic Azad University, Aliabad Katul Branch</contact_name>
        <contact_address>Aliabad Katul city - University Blvd - 4941793451 Aliabad Katul Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
