<?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>IRCT2017040433205N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-19</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Kerman University of Medical Sciences; Haft Baghe Alavi Highway; Kerma</primary_sponsor>
      <public_title>Effects of Exercise on Hemodialysis Patients.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Effects of Exercise Training on Oxidative Stress Parameters in Hemodialysis Patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25684</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Chronic hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Exercise includes cycling with minicycle on the bed in the first hour of every dialysis session and exercise timing has been planned to be less than the tolerance level of the patients. Every session lasts 4 hours and the sessions will be held 3 times a week (every other day) for 8 weeks. Intervention 2: Control group: not any exercise during hemodialysis session.</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>Azadeh Saber</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nephrology Ward; Shafa Hospital; Kowsar Blvd; Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 3121 7243</telephone>
        <email>a.saber@kmu.ac.ir</email>
        <affiliation>University campus, Kerman University of Medical Sciences; Haft Baghe Alavi Highway; Kerman Province</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Saber</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nephrology Ward; Shafa Hospital; Kowsar Blvd; Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618751151</zip>
        <telephone>+98 34 3121 7243</telephone>
        <email>a.saber@kmu.ac.ir</email>
        <affiliation>University campus, Kerman University of Medical Sciences; Haft Baghe Alavi Highway; Kerman Province</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients under hemodialysis three times a week who are interested to do exercise.&#13;
Exclusion criteria: Any infectious or inflammatory disease or active malignancy; Limited circumstances for exercise such as: atopy, asthma, known ischemic heart disease or history of heart attack during past three months; a history of stroke or transient ischemic attack during past three months; Any disorder in the musculoskeletal system such as osteoarthritis, osteoporosis, joint problems and any disability that prevents exercise; Hypoxia; Fever.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Extracorporeal dialysis</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: Exercise includes cycling with minicycle on the bed in the first hour of every dialysis session and exercise timing has been planned to be less than the tolerance level of the patients. Every session lasts 4 hours and the sessions will be held 3 times a week (every other day) for 8 weeks.</i_keyword>
      <i_keyword>Control group: not any exercise during hemodialysis session</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Uric Acid. Timepoint: before and after exercise(8 weeks interval). Method of measurement: biochemistery  tests.</prim_outcome>
      <prim_outcome>Albumin. Timepoint: before and after exercise(8 weeks interval). Method of measurement: biochemistry  test.</prim_outcome>
      <prim_outcome>Ferritin. Timepoint: before and after exercise(8 weeks interval). Method of measurement: biochemistry  test.</prim_outcome>
      <prim_outcome>White Blood Cell. Timepoint: before and after exercise(8 weeks interval). Method of measurement: biochemistry  test.</prim_outcome>
      <prim_outcome>Chain Reactive Protein. Timepoint: before and after exercise(8 weeks interval). Method of measurement: biochemistry  test.</prim_outcome>
      <prim_outcome>Carbonyl Group. Timepoint: before and after exercise(8 weeks interval). Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Malondialdeid. Timepoint: before and after exercise(8 weeks interval). Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Ferric Ion Reductive Ability. Timepoint: before and after exercise(8 weeks interval). Method of measurement: Spectrophotometry.</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>Vice Chancellor for Research, Kerman University of Medical Sciences; Haft Baghe Alavi Highway; Kerma</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2007-02-25</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Central Organization of the University, Shafa crossroad, Jomhori Eslami Blvd, Kerman Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
