<?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>IRCT20171128037667N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Eight-Week Concurrent Training on Expression of Tumor Suppressor Genes in Men with Prostate Cancer</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Eight-Week Concurrent Training on Expression of P53 and P21 Tumor Suppressor Genes in Men with Prostate Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30108</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>prostate cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Experimental group with practice protocol contain a concurrent training course (aerobic-resistance) that designed by the researcher (according to the American College of Medicine-Sports) 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 minutes  Then Resistance training program included four movements of upper and lower large muscle groups that will be excuted 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 repetition that increases by five percent every two weeks. Aerobic exercise with 15 minutes of activity with 60% heart rate maximum, starting at three sessions per week, which is performed with resistance training in one session. [based on the maximum heart rate equation: [(220-years)±10]. Starting The course with 60% maximum heart rate will be added every two weeks 5% to this amount and Five minutes to period. At the end of each exercise session, 10 minutes 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 perform its daily activities and was requested to no participate in exercise training during this period.</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>mohammad asghari rekabdarkolaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Ayatollah Amoli Branch, University feeder, old road Amol to Babol 5 km, Amol</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4771653646</zip>
        <telephone>+98 11 4253 2765</telephone>
        <email>asghari.moh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza barari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Ayatollah Amoli Branch, University feeder, old road Amol to Babol 5 km, Amol</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4635143358</zip>
        <telephone>+98 11 4321 7126</telephone>
        <email>alireza54.barari@gmail.com</email>
        <affiliation>Islamic Azad University</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 and are treated under the same way.
The entering criteria for the study include: Physical health based on a medical history questionnaire that has no history of cardiovascular disease, high blood pressure, diabetes, renal disease, no smoking or participation in any exercise program at least 2 months 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>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Not attending more than 3 sessions
having of heart or lung disease
Change in health that prevent physical activity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D07.5</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Experimental group with practice protocol contain a concurrent training course (aerobic-resistance) that designed by the researcher (according to the American College of Medicine-Sports) 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 minutes  Then Resistance training program included four movements of upper and lower large muscle groups that will be excuted 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 repetition that increases by five percent every two weeks. Aerobic exercise with 15 minutes of activity with 60% heart rate maximum, starting at three sessions per week, which is performed with resistance training in one session. [based on the maximum heart rate equation: [(220-years)±10]. Starting The course with 60% maximum heart rate will be added every two weeks 5% to this amount and Five minutes to period. At the end of each exercise session, 10 minutes 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 perform its daily activities and was requested to no participate in exercise training during this period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>P53 tumor suppressor protein. Timepoint: Before the intervention and the end of the intervention. 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>P21 tumor suppressor protein. Timepoint: Before the intervention and the end of the intervention. 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 and the end of the intervention. 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-03</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
