<?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>IRCT2013061112509N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-09-10</date_registration>
      <primary_sponsor>Nephrology and Urology Research Center</primary_sponsor>
      <public_title>The  effect  of physical and mental exercises during dialysis on adequacy of dialysis and fatigue in dialysis  patients</public_title>
      <acronym></acronym>
      <scientific_title>The  effect  of  planned physical and mental exercises during hemodialysis on adequacy of dialysis and fatigue in hemodialysis  patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12582</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>CKD(ESRD).</hc_freetext>
      <i_freetext>Intervention 1: The amount of urea and the weight were measured prior to hemodialysis through arteriovenous sampling. At the end of hemodialysis and before disconnecting the patient from the machine, an arterial blood sample was once more prepared from the dialyzer. In the end, patients' weight was monitored again and samples were transferred to the Laboratory.&#13;
The dialysis adequacy for both groups was measured before, 1 month after, and 2 months after the intervention and then compared, also fatigue in patients was measured via a fatigue severity scale questionnaire before, one month after, and two months after intervention and then compared. &#13;
Each patient was initially questioned about their kinetic limitations and comorbid diseases so as to propose an exercise program corresponding to their individual capabilities. The exercises were given by a senior expert in physical education during the dialysis half an hour after the patients were connected to the machine. At the beginning of each session, the trainer began taking about the system of the universe, the infinite power of God Almighty and positive thinking about the self. Then, the patients were encouraged to do stretching and flexibility movements. For the limb inflicted with fistula, the patient was told to close their eyes and imagine moving it. During the exercise intervals the patients were required to take a deep breath or do diaphragm breathing with inhalation and exhalation. Ultimately, they were taught to do relaxation exercises under the trainer’s guidance, while a soft music without lyrics was being played. In the next sessions the exercises were extended with respect to the subjects’ capabilities in terms of severity and repetition. They were continued twice a week for almost two months with a maximum time of 20 minutes. Intervention 2: The control group did not receive any intervention. The amount of urea and the weight were measured prior to hemodialysis through arteriovenous sampling. At the end of hemodialysis and before disconnecting the patient from the machine, an arterial blood sample was once more prepared from the dialyzer. In the end, patients' weight was monitored again and samples were transferred to the Laboratory. The dialysis adequacy for both groups was measured before, 1 month after, and 2 months after the study and then compared, also fatigue in patients was measured via a fatigue severity scale questionnaire before, one month after, and two months after study and then compared.</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>Batool Nehrir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Building of Velayat, Street of bedside to the  Artesh Square, The Northern End of the Emam Ali Highway, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956837172</zip>
        <telephone>+98 21 2612 7237</telephone>
        <email>rnehrir1739@yahoo.com</email>
        <affiliation>School of Nursing, Baghiyatallah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Tayebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Building of Velayat, Street of bedside to the  Artesh Square, The Northern End of the Emam Ali Highway, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956837172</zip>
        <telephone>+98 21 2228 9941</telephone>
        <email>tayybi.ali@gmail.com</email>
        <affiliation>School of Nursing, Baghiyatallah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria:Patients’ undergoing hemodialysis 3 times a week who at least three months had passed since the start of hemodialysis; Not participating in the regular exercise program in the past 6 months; Being capable of learning during the exercises; Having no medical prohibition for the exercise; Having no record of ischemic heart disease according to the case history; Having no record of 3rd degree congestive heart failure;  No record of unstable angina. &#13;
 exclusion criteria: High blood pressure over 180.110 mmHg, low blood pressure equal to 90 mmHg; Reluctance to continue participating in the exercises; Kidney transplant; Death</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The amount of urea and the weight were measured prior to hemodialysis through arteriovenous sampling. At the end of hemodialysis and before disconnecting the patient from the machine, an arterial blood sample was once more prepared from the dialyzer. In the end, patients' weight was monitored again and samples were transferred to the Laboratory.&#13;
The dialysis adequacy for both groups was measured before, 1 month after, and 2 months after the intervention and then compared, also fatigue in patients was measured via a fatigue severity scale questionnaire before, one month after, and two months after intervention and then compared. &#13;
Each patient was initially questioned about their kinetic limitations and comorbid diseases so as to propose an exercise program corresponding to their individual capabilities. The exercises were given by a senior expert in physical education during the dialysis half an hour after the patients were connected to the machine. At the beginning of each session, the trainer began taking about the system of the universe, the infinite power of God Almighty and positive thinking about the self. Then, the patients were encouraged to do stretching and flexibility movements. For the limb inflicted with fistula, the patient was told to close their eyes and imagine moving it. During the exercise intervals the patients were required to take a deep breath or do diaphragm breathing with inhalation and exhalation. Ultimately, they were taught to do relaxation exercises under the trainer’s guidance, while a soft music without lyrics was being played. In the next sessions the exercises were extended with respect to the subjects’ capabilities in terms of severity and repetition. They were continued twice a week for almost two months with a maximum time of 20 minutes.</i_keyword>
      <i_keyword>The control group did not receive any intervention. The amount of urea and the weight were measured prior to hemodialysis through arteriovenous sampling. At the end of hemodialysis and before disconnecting the patient from the machine, an arterial blood sample was once more prepared from the dialyzer. In the end, patients' weight was monitored again and samples were transferred to the Laboratory. The dialysis adequacy for both groups was measured before, 1 month after, and 2 months after the study and then compared, also fatigue in patients was measured via a fatigue severity scale questionnaire before, one month after, and two months after study and then compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: before, one month after intervention, two months after intervention. Method of measurement: Fatigue Severity Scale.</prim_outcome>
      <prim_outcome>Adequacy of dialysis. Timepoint: before, one month after intervention, two months after intervention. Method of measurement: Kt/v formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep. Timepoint: before, one month after intervention, two months after intervention. Method of measurement: Pittsburgh questionnaire.</sec_outcome>
      <sec_outcome>Stress. Timepoint: before, one month after intervention , two months after intervention. Method of measurement: DASS questionnaire.</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: before, one month after intervention , two months after intervention. Method of measurement: DASS questionnaire.</sec_outcome>
      <sec_outcome>Depression. Timepoint: before, one month after intervention , two months after intervention. Method of measurement: DASS questionnaire.</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>Nephrology and Urology Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-12-26</approval_date>
        <contact_name>Faculty of Nursing</contact_name>
        <contact_address>Faculty of Nursing, Building of Velayat, Street of bedside to the  Artesh Square, The Northern End of the Emam Ali Highway, Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
