<?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>IRCT20100623004251N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-12</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise on insomnia in patients referred to sleep clinic</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of drug therapy in combination with exercise and drug therapy alone in the treatment of patients with insomnia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39456</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization.
Four blocks of 4 including 2 participants in the intervention group and 2 participants in the control group were used. The blocks were selected by www.sealedenvelope.com.</study_design>
      <phase>N/A</phase>
      <hc_freetext>insomnia.</hc_freetext>
      <i_freetext>Intervention 1: Interventions are increased for 3 months in the form of aerobic and resistance exercise. Aerobic exercise will be performed in the form of walking, 30 minutes daily, three days a week in the first month, 45 minutes a day in the second month and 1 hour a day in the third month with moderate intensity. Twelve weeks of resistance training is considered .Every 4 weeks have same exercise program chosen from 3 models of A, B and C focusing on the large muscles of the lower and upper limbs and central part of the body that will be performed for 3 consecutive days per week. Before each session, patients warm up for 15 minutes with stretching exercises. Every two weeks the weight of the weight will be increased a half kilo so that the first week of every two weeks is three sets of 10, and the second week is three sets of 15, and the intensity increases gradually every two weeks. At the end of each session cooling down will be done for 5 to 10 minutes. The intervention group will be provided with a summary of these movements and their order through a booklet. The practitioner instructs patients on all movements during the first visit. Patients will record each movement after doing it in the report table given to them. Intervention 2: Control group: patient with insomnia.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Sleep quality data available in the pittsburgh questionnaire

When:
From the time the article was published until five years later

To whom:
Researchers working in academic centers who systematically intend to use these findings in meta-analysis.

Conditions:
Due to the presence of the authors of this article in the academic center, there is a need to obtain written permission from the university to submit data. Therefore, after requesting data, this data will be sent within 6 months (after university approval).

Where to obtain:
Rasoul Akram Hospital of Sports Medicine
Dr. Hale Dadgostar, Dr. Afsane Basharkhah

How to obtain:
Upon requesting documentation, the researcher must obtain a written permission from the research project and submit the documentation after obtaining permission. So the estimated time to send the data is about 6 months after their request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Haleh Dadgostar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6651 5001</telephone>
        <email>dadgostar.h@iums.ac.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haleh dadgostar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6651 5001</telephone>
        <email>dadgostar.h@iums.ac.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People who have diagnostic criteria for insomnia based on psychiatric examinations
People with systolic and diastolic blood pressure of less than 180 and 100, respectively
People with less than 30 minutes of activity per day
People who have completed the consent form of the study in the study</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with cardiovascular disease or history of cardiovascular disease
People with uncontrolled diabetes
People with uncontrolled respiratory illness
Patients who are not able to exercise for any reason
Patients whose symptoms of sleep disorder strongly suggest other sleep disturbances other than Insomnia, such as sleep apnea and restlessness syndrome</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Insomnia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions are increased for 3 months in the form of aerobic and resistance exercise. Aerobic exercise will be performed in the form of walking, 30 minutes daily, three days a week in the first month, 45 minutes a day in the second month and 1 hour a day in the third month with moderate intensity. Twelve weeks of resistance training is considered .Every 4 weeks have same exercise program chosen from 3 models of A, B and C focusing on the large muscles of the lower and upper limbs and central part of the body that will be performed for 3 consecutive days per week. Before each session, patients warm up for 15 minutes with stretching exercises. Every two weeks the weight of the weight will be increased a half kilo so that the first week of every two weeks is three sets of 10, and the second week is three sets of 15, and the intensity increases gradually every two weeks. At the end of each session cooling down will be done for 5 to 10 minutes. The intervention group will be provided with a summary of these movements and their order through a booklet. The practitioner instructs patients on all movements during the first visit. Patients will record each movement after doing it in the report table given to them.</i_keyword>
      <i_keyword>Control group: patient with insomnia</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Insomnia. Timepoint: before intervention and 3 month after intervention. Method of measurement: Pittsburgh 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-20</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahrara St, Satarkhan St,Tehran،Tehran Province, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
