<?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>IRCT20240121060758N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-28</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Aerobic Exercise on the Severity of Suicidal Ideation and Disease Symptoms in Schizophrenic Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Aerobic Exercise on the Severity of Suicidal Ideation and Disease Symptoms in Schizophrenic Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75078</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: In this study, aerobic exercises will be performed for 8 weeks on even days of the week for 30 minutes, and at the end of the intervention, the control group will be taught the ethical considerations of aerobic exercises in one session, Randomization description: Block Randomization, Blinding description: In this study, aerobic exercises will be performed for 8 weeks on even days of the week for 30 minutes, and at the end of the intervention, the control group will be taught the ethical considerations of aerobic exercises in one session.To consider single blinding , the participants will be informed that the intervention will take place at two different times.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Aerobic exercises will be performed for 15 patients with schizophrenia during 8 weeks on even days of the week for 30 minutes. These exercises include 5 minutes of warm-up (soft running, combined movements of arms and legs and stretching), 20 minutes of main exercise including 10 minutes of running with an intensity of 60 to 80% of the maximum heart rate and 10 minutes of invisible rope jumping in 5 sets (30 times in each set). After each set, patients will rest for 1 minute by running slowly in place and breathing deeply. At the end, it is 5 minutes to cool down and return to the initial position. Intervention 2: Control group: For 15 patients with schizophrenia, after the end of the intervention, aerobic exercises will be performed during one session for 30 minutes. These exercises include 5 minutes of warm-up (soft running, combined movements of arms and legs and stretching movements), 20 minutes of main exercise. It consists of 10 minutes of running at an intensity of 60-80% of maximum heart rate and 10 minutes of in situ invisible rope jumping in 5 sets (30 times per set). After each set, patients will rest for 1 minute by running slowly in place and breathing deeply. At the end, it is 5 minutes to cool down and return to the initial position.</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 based on ethical issues</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Sheykh fendereski</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.44, 3th Standard Ave., Standard Blvd</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4916698173</zip>
        <telephone>+98 17 3235 3523</telephone>
        <email>sara12345678sh@chmail.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Davood Oudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghafari Blvd., Birjand University of Medical Sciences</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853076</zip>
        <telephone>+98 56 3239 5000</telephone>
        <email>davoodoudi@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to cooperate in research.
Have at least one period of hospitalization with a diagnosis of schizophrenia.
Age between 18 and 65 years.
In terms of physical health, have enough health to participate in the sports program.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from another mental illness except schizophrenia.
Participating in another research project at the same time</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</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:Aerobic exercises will be performed for 15 patients with schizophrenia during 8 weeks on even days of the week for 30 minutes. These exercises include 5 minutes of warm-up (soft running, combined movements of arms and legs and stretching), 20 minutes of main exercise including 10 minutes of running with an intensity of 60 to 80% of the maximum heart rate and 10 minutes of invisible rope jumping in 5 sets (30 times in each set). After each set, patients will rest for 1 minute by running slowly in place and breathing deeply. At the end, it is 5 minutes to cool down and return to the initial position.</i_keyword>
      <i_keyword>Control group: For 15 patients with schizophrenia, after the end of the intervention, aerobic exercises will be performed during one session for 30 minutes. These exercises include 5 minutes of warm-up (soft running, combined movements of arms and legs and stretching movements), 20 minutes of main exercise. It consists of 10 minutes of running at an intensity of 60-80% of maximum heart rate and 10 minutes of in situ invisible rope jumping in 5 sets (30 times per set). After each set, patients will rest for 1 minute by running slowly in place and breathing deeply. At the end, it is 5 minutes to cool down and return to the initial position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Score of Suicidal Ideation in the Beck Questionnaire. Timepoint: Before the Start of the Intervention, The Second Week, The Fourth Week After the Start of the Intervention and After the End of the Intervention. Method of measurement: Beck Suicidal Ideation Questionnaire.</prim_outcome>
      <prim_outcome>Score of Positive and Negative Syndrome Scale Questionnaire. Timepoint: Before the Start of the Intervention, The Second Week, The Fourth Week After the Start of the Intervention and After the End of the Intervention. Method of measurement: Positive and Negative Syndrome Scale Questionnaire.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-20</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Ghafari Blvd.,Birjand University of Medical Science Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
