<?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>IRCT20140412017237N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-20</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of walking and Pilates exercise at home on quality of life, functional capacity and anthropometric measurements in elderly women with diabetes type 2</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of walking and Pilates exercise at home on quality of life, functional capacity and anthropometric measurements in elderly women with diabetes type 2</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47131</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The eligible patients as an unit of randomization will be allocated in two intervention groups (1:walking at home, 2: Pilates exercise at home) using Randomizer software by simple randomization, Blinding description: Due to the nature of the interventions, only the outcome assessor will be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 (walking at home): Walking at home for 45 minutes, three times a week for 3 months, which will be performed by an experienced instructor after training. Intervention 2: Intervention group 2 (Pilates exercises at home): A selection of Pilates exercises at the beginner and basic level of Pilates is done lying down and without special tools at home. These movements are accompanied by the coordination of inhaling and exhaling in the performance of the movement, which will be for 45 minutes, three times a week for 3 months, which will be performed by an experienced instructor after training.</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:
All data will be shared after unidentifiable participants.

When:
6 months after publication the data files will be available.

To whom:
The data will be shared for people working in academic institutions.

Conditions:
Meta analyses on data is permitted.

Where to obtain:
Please contact to person responsible for general inquiries.

How to obtain:
The data will be available through email.

Comments:
Please contact to both email address: 
modanloo.mahnaz@goums.ac.ir
modanloo.mahnaz@gmail.com</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Modanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Research Center, Golestan University of Medical Sciences, Hirkan Boulevard</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917136536</zip>
        <telephone>+98 17 3245 6900</telephone>
        <email>modanloo.mahnaz@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamideh Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Internal medicine, Faculty of Medicine, Golestan University of Medical Sciences</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 17 3222 0561</telephone>
        <email>dr.akbari.h@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of Diabetes mellitus type 2 from 1 year ago
60-75 years old
Lack of physical disability
Lack of known psychiatric disorder
Lack of diabetes complications</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Under weight lost diet
Contraindication of physical exercises based on physician advice
Nursing home residents
Hospitalization</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10-E14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 (walking at home): Walking at home for 45 minutes, three times a week for 3 months, which will be performed by an experienced instructor after training.</i_keyword>
      <i_keyword>Intervention group 2 (Pilates exercises at home): A selection of Pilates exercises at the beginner and basic level of Pilates is done lying down and without special tools at home. These movements are accompanied by the coordination of inhaling and exhaling in the performance of the movement, which will be for 45 minutes, three times a week for 3 months, which will be performed by an experienced instructor after training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Quality of life measurement before intervention and immediately and one months after intervention. Method of measurement: Quality of life questionnaire (SF-36).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional capacity. Timepoint: Measurement of functional capacity before intervention and immediately and one months after intervention. Method of measurement: Evaluated by TUG, 2-10MWT, STS5-3, OLS tests.</sec_outcome>
      <sec_outcome>Anthropometry. Timepoint: Measurement of anthropometric indicators before intervention and immediately and one months after intervention. Method of measurement: Measuring body dimensions in a static state, which includes height, weight, body mass index, waist circumference, pelvic circumference, waist-to-height ratio, waist-to-hip ratio, mass and body fat percentage of patients. Weight will be measured using a digital scale made in Iran with an accuracy of 100 grams, height, waist circumference, pelvic circumference using a tape measure made in Iran with an accuracy of 0.1 cm. Body fat percentage will be measured using the BIA by the OMRON BF-511.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-27</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
