<?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>IRCT201011044251N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-12-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences (Research Department)</primary_sponsor>
      <public_title>The effect of group therapy in ‎patients with type 2 diabetes‎</public_title>
      <acronym></acronym>
      <scientific_title>The effect of exercise consultation and exercise therapy on quality of life in ‎patients with type 2 diabetes‎‏:‏‎ A randomized clinical trial‎                   ‎</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4510</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabete‎s.</hc_freetext>
      <i_freetext>Intervention 1: The control group will only receive an educational booklet, and a systematic intervention program will not be given. They have just one session (30 minutes) by sports medicine specialist about health screening, education of booklet and exercise prescription, individually. They don’t have another session during 6 weeks of the study. Also, consultation to change other aspects of lifestyle (nutrition and diet consultation) will be given to all patients. Intervention 2: The intervention group: The 6-week group therapy will be provided in 6 sessions once a week by sports medicine specialist (2 hours) consisted of: health screening (blood pressure and body weight check), education, exercise prescription and counseling. Also, once a week, contact with participants by phone will be done for giving necessary recommendations about exercise training by sports medicine specialist. Exercise program will be 3 sessions per week consisted of warm-up, stretching, strength training, aerobic and cool-down exercises for 60 minutes per session. Participants will be encouraged to perform walking exercise in other days. Also, consultation to change other aspects of lifestyle (nutrition and diet consultation) will be given to all patients. The patients can call during the week for receiving the necessary exercise consultation.</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>Haleh Dadgostar, MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Rasool Hospital ,Niayesh St., Satarkhan Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6651 5001</telephone>
        <email>hldadgostar@gmail.com- halehd@iums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haleh Dadgostar, MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Rasool Akram Hospital, Niayesh St., Satarkhan Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6651 5001</telephone>
        <email>hldadgostar@gmail.com halehd@iums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: known history of type 2 diabetes, age more than 30 years old, not engaged in physical activity more than 2 hours/week, not receiving insulin, the absence of ST changes in ECG; history of chest pain or pressure, dyspnea on exertion, unexplained gastrointestinal complaints; uncontrolled BP (resting systolic BP &gt;200mmHg or diastolic BP &gt;110mmHg); resting tachycardia (100 beats/min); absence of clinical findings of diabetic micro- or macrovascular complications (retinopathy, autonomic neuropathy, nephropathy), Not orthopedic problem for patient’s activity, ability to read and speak in Persian&#13;
Exclusion criteria: taking glucocorticoids, absence in more than one session of group therapy session</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group will only receive an educational booklet, and a systematic intervention program will not be given. They have just one session (30 minutes) by sports medicine specialist about health screening, education of booklet and exercise prescription, individually. They don’t have another session during 6 weeks of the study. Also, consultation to change other aspects of lifestyle (nutrition and diet consultation) will be given to all patients.</i_keyword>
      <i_keyword>The intervention group: The 6-week group therapy will be provided in 6 sessions once a week by sports medicine specialist (2 hours) consisted of: health screening (blood pressure and body weight check), education, exercise prescription and counseling. Also, once a week, contact with participants by phone will be done for giving necessary recommendations about exercise training by sports medicine specialist. Exercise program will be 3 sessions per week consisted of warm-up, stretching, strength training, aerobic and cool-down exercises for 60 minutes per session. Participants will be encouraged to perform walking exercise in other days. Also, consultation to change other aspects of lifestyle (nutrition and diet consultation) will be given to all patients. The patients can call during the week for receiving the necessary exercise consultation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: The short form health survay (SF-36).</prim_outcome>
      <prim_outcome>TG. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>HDL. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>LDL. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Total cholestrol. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Diastolic pressure. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: Sphygmomanometer.</prim_outcome>
      <prim_outcome>FBS. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: Sphygmomanometer.</prim_outcome>
      <prim_outcome>Hb A1c. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Weight. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: scale.</prim_outcome>
      <prim_outcome>BMI. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: weight(kg)/Square of height(meter).</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: meter.</prim_outcome>
      <prim_outcome>Physical functioning. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: The short form health survey(SF-36).</prim_outcome>
      <prim_outcome>Role physical. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: The short form health survey(SF-36).</prim_outcome>
      <prim_outcome>Social functioning. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: The short form health survey(SF-36).</prim_outcome>
      <prim_outcome>Mental health. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: The short form health survey(SF-36).</prim_outcome>
      <prim_outcome>Bodily pain. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: The short form health survey(SF-36).</prim_outcome>
      <prim_outcome>Vitality. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: The short form health survey(SF-36).</prim_outcome>
      <prim_outcome>General health. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: The short form health survey(SF-36).</prim_outcome>
      <prim_outcome>Role emotional. Timepoint: before intervention and after 6 weeks of intervention. Method of measurement: The short form health survey(SF-36).</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>Tehran University of Medical Sciences (Research Department)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-10-24</approval_date>
        <contact_name>Ethics committee in Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
