<?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>IRCT201412282324N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-06-02</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Iran  University of Medical Sciences</primary_sponsor>
      <public_title>Pilates and  Aerobic  Exercise and Quality of Sleep  and  Fatigue</public_title>
      <acronym></acronym>
      <scientific_title>Effect of  Pilates and  Aerobic  Exercise on Quality of  Sleep  and  Fatigue  of Girl  Students  of Dormitory</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1970</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Quality of Sleep. Condition 2: Fatigue.</hc_freetext>
      <i_freetext>Intervention 1: The control group continued their daily activities. Intervention 2: The intervention group 1: Pilates exercise will be done for 8 weeks. After completing initial Quality of Sleep Questionnaires,Fatigue Questionnaires, demographic questionnaires and having inclusion criteria, samples will be trained by instructor and researcher for 8 weeks,3 times per week, 60 minutes per time. Quality of Sleep questionnaires and fatigue questionnaires will be completed 4 and 8 weeks after starting the intervention. Intervention 3: The intervention group 2: Aerobic Exercise will be done for 8 weeks. After completing initial Quality of Sleep Questionnaires,Fatigue Questionnaires, demographic questionnaires and having inclusion criteria, samples will be trained by instructor and researcher for 8 weeks,3 times per week, 60 minutes per time. Quality of Sleep questionnaires and fatigue questionnaires will be completed 4 and 8 weeks after starting the intervention.</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>Ezzati Mosleh Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,Rashid Yasemi St,Vliasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3825 4708</telephone>
        <email>aryai0812@gmail.com</email>
        <affiliation>School Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Keshavarz Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,Rashid Yasemi St,Valiasr St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>Keshavarz.m@iums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include single, Iranian and healthy girls  whose their general health are validated before coming to study, aged 18 to 26 years, no history of any regularly physical activities for last 6 months, Body mass index 19/8 to 26, lack of misuse the drug, lack of stressful experiences during the last 3 months. Exclusion criteria include Lack of training for three continuous or five non-continuous sessions, lack of tendency to continue cooperation, use of effective foods for sleeping and fatigue such as coffee, espresso and energetic drinks, use of effective non-medical methods for  fatigue and quality of sleep such as acupressure, use of effective psychiatric drugs for  fatigue and quality of sleep during the study  such as Floxetine and Citalopram, the occurrence of stressful  experiences during the study, marriage during the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>26 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F51.9</hc_code>
      <hc_code>F48.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonorganic sleep disorder, unspecified</hc_keyword>
      <hc_keyword>Fatigue  Psychogenic (general)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group continued their daily activities.</i_keyword>
      <i_keyword>The intervention group 1: Pilates exercise will be done for 8 weeks. After completing initial Quality of Sleep Questionnaires,Fatigue Questionnaires, demographic questionnaires and having inclusion criteria, samples will be trained by instructor and researcher for 8 weeks,3 times per week, 60 minutes per time. Quality of Sleep questionnaires and fatigue questionnaires will be completed 4 and 8 weeks after starting the intervention.</i_keyword>
      <i_keyword>The intervention group 2: Aerobic Exercise will be done for 8 weeks. After completing initial Quality of Sleep Questionnaires,Fatigue Questionnaires, demographic questionnaires and having inclusion criteria, samples will be trained by instructor and researcher for 8 weeks,3 times per week, 60 minutes per time. Quality of Sleep questionnaires and fatigue questionnaires will be completed 4 and 8 weeks after starting the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Sleep. Timepoint: Before the Intervention, 4 and 8 weeks after Intervention. Method of measurement: Pittsburg Quality of Sleep Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fatigue. Timepoint: Before the Intervention,4 and, 8 weeks after Intervention. Method of measurement: MFI Fatigue Inventory.</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, Iran  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-06</approval_date>
        <contact_name>Ethical Commitment of  Iran University of  Medical Sciences</contact_name>
        <contact_address>Hemat Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
