<?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>IRCT20200928048866N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-29</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigation of aerobic exercise effect on prostate cancer</public_title>
      <acronym>TPCS</acronym>
      <scientific_title>The effect of an aerobic exercise course on the associated serum microRNA levels with antiangiogenesis and cell death in prostate cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51274</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, the effect of exercise activities on angiogenesis and anti-angiogenesis factors and microRNA changes has been investigated in cancer patients by monitoring some microRNAs and factors that increase the associated angiogenesis with cancer and it can cause metastasis and resistance to chemotherapy and other treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The role of exercise and microRNAs in prostate cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Resistance training consisted includes eight weeks and 3 sessions per week. The program includes a 10-minute warm-up session with a various of stretching, flexibility and running exercises. Then, continuous running with a constant trend and intensity of 60 to 70% of HRR (Carvonen formula) was performed using a pulse gauge belt. The duration of running was 15 minutes in the first session and one minute was added to each session in the running time. The maximum heart rate was calculated from the formula age-220. At the end of each session, the cooling operation will be achieved by performing soft running, stretching and soft movements for ten minutes. Intervention 2: Control group: without treatment and participate in exercise. It plays important role in the experimental process.</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 Failure to complete information in this issue</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi garshasbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO 22, Banafsheh 3 Ave, South Star Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1473993374</zip>
        <telephone>+98 21 4447 2341</telephone>
        <email>md_garshasb@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hussein Abed Natanzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Science and Research Branch, Islamic Azad University، Shohada Hesarak Blv, University Square,   End of Shahid Sattari Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5154</telephone>
        <email>abednazari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtaining the necessary permits for referring to specialized oncology treatment centers
Failure to do the radiation therapy, chemotherapy and androgen therapy
They have been diagnosed with prostate cancer at least one month ago
Do not smoke or drink alcohol
No physical problems that prevent exercise such as orthopedic, brain problems and nerve
All patients with benign prostate cancer</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>66 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Blood pressure&gt; 180/110
Cardiovascular diseases
History of surgery
Family dissatisfaction
Overweight</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C60-c63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of prostate</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Resistance training consisted includes eight weeks and 3 sessions per week. The program includes a 10-minute warm-up session with a various of stretching, flexibility and running exercises. Then, continuous running with a constant trend and intensity of 60 to 70% of HRR (Carvonen formula) was performed using a pulse gauge belt. The duration of running was 15 minutes in the first session and one minute was added to each session in the running time. The maximum heart rate was calculated from the formula age-220. At the end of each session, the cooling operation will be achieved by performing soft running, stretching and soft movements for ten minutes.</i_keyword>
      <i_keyword>Control group: without treatment and participate in exercise. It plays important role in the experimental process</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people with decreasing the serum mirRNA-15a. Timepoint: Pre and post-test. Method of measurement: Blood test (RNA extraction kit for Riz biofanavaran company. And also, RT steam-loop house keeping method was used to check microRNA levels).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The percentage of people with decreasing the serum mirRNA-329. Timepoint: Pre and post-test. Method of measurement: Blood test (RNA extraction kit rena biotechnology company. And also, RT steam-loop house keeping method was used to check microRNA levels).</sec_outcome>
      <sec_outcome>The percentage of people with decreasing the serum mirRNA-16-1. Timepoint: Pre and post-test. Method of measurement: Blood test (RNA extraction kit rena biotechnology company. And also, RT steam-loop house keeping method was used to check microRNA levels).</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>Vice Chancellor for Research, University of Research Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ethics Committee of Qom University</contact_name>
        <contact_address>Unit 4, No. 22, , Banafsheh Alley, Jihad Akbar St., Sattari Highway Mojahed Kabir St., West Laleh Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
