<?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>IRCT20190120042436N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-26</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aerobic and resistance exercise on the adequacy of dialysis and the quality of life of hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two methods of aerobic and resistance exercises on the adequacy of dialysis and the quality of life in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39622</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Firstly, according to the criteria for entering the patients who are willing to participate in the study, they are divided into three groups A, B, and C according to the formula. The two groups are divided into six groups according to formula (2): Draw the first illness in the middle section of the group, select the control group, the aerobic and resistance exercises, in the order indicated in the draw sheet. Again, the selected team will be returned to the Lottery Cup to complete the draw, Blinding description: In this study, the data analyst does not know the allocation of study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first intervention group: For resistance exercise, warming up is a simple tensile movement in all four muscle groups in the form of flexion and extension of the elbow joint, the upper and lower sides of the arm. Intervention 2: The second intervention group: With use of a low-intensity bike, after warming the body for 5 minutes, for 15-60 minutes of exercise, according to protocol. The beginning of exercise for the first week will be as follows. First, a weight will be given to the patient who can only open his hand once (one maximum repetition) and then heals 60 to 65 percent of the weight of the above three training periods To be The number of repetitive exercises will be 8 to 10 times. The rest time will be 1 to 3 minutes after each round of training. The training of the following weeks will be done according to protocol. The duration of resistance exercise starts from 12-15 minutes in the first weeks and ends at 36-48 minutes in the seventh and eighth weeks. Intervention 3: Control group: Receive routine care.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohsen Salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Jalil St.,  Nursing School of Hazrat Zaynab (SA), Yasuj, Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>75919-94799</zip>
        <telephone>+98 74 3323 5140</telephone>
        <email>salarimo@yums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Jalil St., Faculty of Nursing, Yasuj, Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>75919-94799</zip>
        <telephone>+98 74 3323 5140</telephone>
        <email>salarimo@yamse.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have at least six months of dialysis history
At least twice a week dialysis
No known ischemic disease based on history
Not having the history of heart attacks and angina during the last six months
Lung disease requiring artificial oxygen
No history of stroke or transient ischemic attacks during the past three months
Not having a disturbance in the musculoskeletal system and the leg in the leg that prevents the intended sporting activity (pedaling by bicycle).
No use of beta-blocker and no uncontrolled blood pressure
At the same time, there is not under supervision of another study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having known ischemic disease based on history
Having a history of heart attacks and angina during the last 6 months.
Having pulmonary disease requiring artificial oxygen.
Having a history of stroke or transient ischemic attacks in the past three months.
Having Disorders of musculoskeletal system in the leg that prevent the exercise (bicycle pedaling).
Use of beta-blocker and uncontrolled blood pressure.
At the same time, there is under supervision of another study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first intervention group: For resistance exercise, warming up is a simple tensile movement in all four muscle groups in the form of flexion and extension of the elbow joint, the upper and lower sides of the arm.</i_keyword>
      <i_keyword>The second intervention group: With use of a low-intensity bike, after warming the body for 5 minutes, for 15-60 minutes of exercise, according to protocol. The beginning of exercise for the first week will be as follows. First, a weight will be given to the patient who can only open his hand once (one maximum repetition) and then heals 60 to 65 percent of the weight of the above three training periods To be The number of repetitive exercises will be 8 to 10 times. The rest time will be 1 to 3 minutes after each round of training. The training of the following weeks will be done according to protocol. The duration of resistance exercise starts from 12-15 minutes in the first weeks and ends at 36-48 minutes in the seventh and eighth weeks.</i_keyword>
      <i_keyword>Control group: Receive routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dialysis adequacy. Timepoint: Before intervention and after intervention. Method of measurement: Formula.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and after the study. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: At the time of the intervention. Method of measurement: With a cardiopulmonary monitoring device.</sec_outcome>
      <sec_outcome>Pulse. Timepoint: At the time of the intervention. Method of measurement: With a cardiopulmonary monitoring device.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-10</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Shahid Dr. Jalil St., Faculty of Nursing, Yasuj Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
