<?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>IRCT201011085133N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-01-03</date_registration>
      <primary_sponsor>Tonekabon Azad University</primary_sponsor>
      <public_title>The efficacy of physical exercise and token behavior therapy on reducing the negative symptoms in schizophrenic patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the efficacy of physical exercise to token behavior therapy on the rate of negative symptoms in schizophrenic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5455</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Physical exercise was carried out within 16 sessions, including physical movements with 7 minute-running, 3 minute-in situ running, 7 minute-stretching starting from upper body to lower body, 10 minute-dynamic exercise, 3 minute-cooling down. Intervention 2: Control group: No intervention. Intervention 3: Token behavior therapy: token economics was applied aimed at reducing negative symptoms in schizophrenic patients. Schizophrenic patients were awarded tokens on account of displaying positive behaviors such as: 1) participating in therapeutic activities, 2) properly washing face after waking up, 3) tooth brushing, 4) being tidy and organized, 5) responding to the questions and taking part in conversations. These patients lost tokens due to displaying negative behaviors such as: 1) not participating in therapeutic activities, 2) not properly washing face after waking up, 3) shouting at other people, 4) not being tidy and organized, 5) not responding to the questions asked and not taking part in conversations.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kamran Gholinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tonekabon Azad University, Vali Abad Educational Complex, 2nd kilometer of Chaloos road</address>
        <city>Tonekabon</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 911 130 9728</telephone>
        <email>kgolinia@yahoo.com</email>
        <affiliation>Tonekabon Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnam Abolghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tonekabon Azad University, Vali Abad Educational Complex, 2nd kilometer of Chaloos road</address>
        <city>Tonekabon</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 911 391 3907</telephone>
        <email>abolghasemi@tonekaboniau.ac.ir</email>
        <affiliation>Tonekabon Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: at least 3 years passed from disorder outset, male gender, age 20-50 years, no mental illness and disorders along with schizophrenia, no mental retardation or brain damage, having active case in Organizing Committee for Chronic Psychiatric Patients&#13;
Exclusion criteria: displaying severe physical illness, change of diagnosis within the period or displaying other prominent psychiatric symptoms, death, moving from the Care Center</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></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>Behavior</i_code>
      <i_code>N/A</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Physical exercise was carried out within 16 sessions, including physical movements with 7 minute-running, 3 minute-in situ running, 7 minute-stretching starting from upper body to lower body, 10 minute-dynamic exercise, 3 minute-cooling down</i_keyword>
      <i_keyword>Control group: No intervention</i_keyword>
      <i_keyword>Token behavior therapy: token economics was applied aimed at reducing negative symptoms in schizophrenic patients. Schizophrenic patients were awarded tokens on account of displaying positive behaviors such as: 1) participating in therapeutic activities, 2) properly washing face after waking up, 3) tooth brushing, 4) being tidy and organized, 5) responding to the questions and taking part in conversations. These patients lost tokens due to displaying negative behaviors such as: 1) not participating in therapeutic activities, 2) not properly washing face after waking up, 3) shouting at other people, 4) not being tidy and organized, 5) not responding to the questions asked and not taking part in conversations</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Negative symptoms. Timepoint: Before the intervention, three months after intervention, the end of intervention. Method of measurement: The Scale for Assessment of Negative Symptoms (SANS).</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>Tonekabon Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-10-29</approval_date>
        <contact_name>Tonekabon Azad University</contact_name>
        <contact_address>Tonekabon Azad University, Vali Abad Educational Complex, 2nd  kilometer of Chaloos road Tonekabon  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
