<?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>IRCT20180624040222N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-11</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The Impact of concurrent (aerobic-resistance) training on prostate cancer</public_title>
      <acronym></acronym>
      <scientific_title>The Impact of concurrent (aerobic-resistance) training on serum levels of IGF-I and IGFBP-3 in men with prostate cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33746</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Due to the health status and acceptance of the patients to the testing stages, use the selection method the maximum sample in the Morgan table, 20 men aged 51-75 years old and BMI of 23-29 KG/m2 randomly divided in to two groups of 10 Control unit and experimental. based on sortition, odd and even numbers were selected for experimental and control groups,respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prostate cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Intervention group with practice protocol contain a concurrent training course ( aerobic-resistance ) that designed by the researcher( according to the American College of Sports Medicine ) for three days a week for 8 weeks. the concurrent training program combines endurance training and resistance training that runs in two equal time steps which includes 55 minutes of training in the first and second weeks to 70 minutes in the seventh and eighth weeks. Warm up for 10 minute then resistance training program included four movements of upper  and lower large muscle groups that will be executed three session per week with a severity of 60 to 75%, One-repetition maximum, and for two time with 10 repetitions and three- minute break between turns. the beginning of the course with 60% of maximal repetitions that increases bye five percent every two weeks. Aerobic training with 15 minutes of activity with 60% heart rate maximum, starting at three session per week, which is performed with resistance training in one session.[ based on the maximum heart rate will be added every two weeks 5% to this a amount and five minute to period. at the end of each exercise session , 10 minute recovery to original state and cool down ( slow running, walking  and tensile movements for recovery) will be done. Intervention 2: Control group:  The control group will continue to carry out regular daily activities and there was no intervention in them.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Ghadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah EI- Azam Subspeciality Hospital, Sheikh Bahai Av, Mulla Sadra St, Vanak Sq,Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8805 0435</telephone>
        <email>P_Ghdian@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid arazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Guilan, Postal Code 4199613776, Khalij Fars highway (5th km of Ghazvin road).</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13336902557</telephone>
        <email>Hamidarazi@yahoo.com</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects are putted at the stage T1 and T2 of the disease .
Physical health based on a medical history questionnaire that has no history of  disease.
No participation in any exercise program atlast 2 month before take part in exercise training program.
Subjects get allowed to enter the project after a cardiovascular examination, blood pressure measurement and ECG monitoring by a specialist.
Take the physical activities readiness questionnaire ( PAR-Q) and  The informed consent form for participation in this research by subjects.</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having of heart or lung disease.
Having high blood pressure.
Having diabetes
Having renal disease
smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>DO7.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carcinoma in situ of prostate</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Intervention group with practice protocol contain a concurrent training course ( aerobic-resistance ) that designed by the researcher( according to the American College of Sports Medicine ) for three days a week for 8 weeks. the concurrent training program combines endurance training and resistance training that runs in two equal time steps which includes 55 minutes of training in the first and second weeks to 70 minutes in the seventh and eighth weeks. Warm up for 10 minute then resistance training program included four movements of upper  and lower large muscle groups that will be executed three session per week with a severity of 60 to 75%, One-repetition maximum, and for two time with 10 repetitions and three- minute break between turns. the beginning of the course with 60% of maximal repetitions that increases bye five percent every two weeks. Aerobic training with 15 minutes of activity with 60% heart rate maximum, starting at three session per week, which is performed with resistance training in one session.[ based on the maximum heart rate will be added every two weeks 5% to this a amount and five minute to period. at the end of each exercise session , 10 minute recovery to original state and cool down ( slow running, walking  and tensile movements for recovery) will be done.</i_keyword>
      <i_keyword>Control group:  The control group will continue to carry out regular daily activities and there was no intervention in them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Phosphatase and tensin homolog (PTEN). Timepoint: Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training). Method of measurement: Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.</prim_outcome>
      <prim_outcome>Insulin-like growth factor 1 (IGF-1). Timepoint: Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training). Method of measurement: Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.</prim_outcome>
      <prim_outcome>Insulin-like growth factor-binding protein 3. Timepoint: Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training). Method of measurement: Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.</prim_outcome>
      <prim_outcome>Sex hormone-binding globulin (SHBG). Timepoint: Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training). Method of measurement: Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.</prim_outcome>
      <prim_outcome>Aerobic capacity. Timepoint: Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training). Method of measurement: To estimate the maximum oxygen consumption, the Modified Bruce test on the treadmill [ based on the maximum oxygen consumption equation: 8.545 +(test run time × 2.282).</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-01</approval_date>
        <contact_name>Ethics Committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Baqiyatallah EI- Azam Subspeciality Hospital, Sheikh Bahai Av, Mulla Sadra St, Vanak Sq. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
