<?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>IRCT20170120032066N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-17</date_registration>
      <primary_sponsor>Shahroud Unversity of Technology</primary_sponsor>
      <public_title>Circuit resistance training and arterial stiffness in neuropathy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of circuit resistance training on arterial stiffness in type 2 diabetic men with peripheral neuropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43652</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be enrolled by one of the research colleagues. A person, blinded to group allocation will provide a random allocation sequence using computer software of SAS prior to the initiation of the study to be used to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 4, 6) will be applied to ensure an equal number of participants in each group. Group allocation will be concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes will be opened after the enrolled participants are analyzed. In this study the instructor and participants will not be blinded to the group allocation but laboratory specialists  and data analyst will be blinded to the group allocation, Blinding description: In this study the instructor and participants will not be blinded to the group allocation but laboratory specialists and data analyst will be blinded to the group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Peripheral Neuropathy of Type 2 Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Circuit resistance training over 3 months with the frequency of 3 sessions per week and 36 sessions in total, with the intensity of 50-70% of one repetition maximum . Intervention 2: Control group: no further activity other than daily physical activity.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farhad Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7-Tir Square,. Tehran St.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 5900</telephone>
        <email>gholami.farhaad@gmail.com</email>
        <affiliation>Shahroud University of Technology</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farhad Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7-Tir Square,. Tehran St.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 5900</telephone>
        <email>gholami.farhaad@gmail.com</email>
        <affiliation>Shahroud University of Technology</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of type 2 diabetes for more than 5 years
diagnose of peripheral neuropathy by a neurologist
HbA1c over 6.6%
No restriction for exercise
Sedentary life-style</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>regular exercise training
Orthopedic problems
Heart Surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with diabetic polyneuropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Circuit resistance training over 3 months with the frequency of 3 sessions per week and 36 sessions in total, with the intensity of 50-70% of one repetition maximum .</i_keyword>
      <i_keyword>Control group: no further activity other than daily physical activity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ankle-brachial index. Timepoint: Before and after the intervention. Method of measurement: Arterial stiffness analyzer.</prim_outcome>
      <prim_outcome>Toe-brachial Index. Timepoint: Before and after the intervention. Method of measurement: Arterial stiffness analyzer.</prim_outcome>
      <prim_outcome>Cardio-ankle vascular stiffness index. Timepoint: Before and after the intervention. Method of measurement: Arterial stiffness analyzer.</prim_outcome>
      <prim_outcome>Score of neuropathy symptomes. Timepoint: Before and after the intervention. Method of measurement: Michigan diabetic neuropathy score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before and after the intervention. Method of measurement: Blood pressure monitor.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before and after the intervention. Method of measurement: Blood pressure monitor.</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: Before and after the intervention. Method of measurement: Calorimetric method.</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>Shahroud Unversity of Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-30</approval_date>
        <contact_name>Ethics Committee of Shahroud university of medical sciences</contact_name>
        <contact_address>7-Tir Square., Tehran St. Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
