<?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>IRCT20091017002599N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-27</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of planned walking on fatigue of patients with acute leukemia</public_title>
      <acronym></acronym>
      <scientific_title>Effect of the Planned Walking Exercise Program on Cancer-related Fatigue among Patients with Acute Myeloid Leukemia Undergoing Chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28399</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute Myeloid Leukemia.</hc_freetext>
      <i_freetext>Intervention group: The researcher provided a quiet and private place in the hospital’s courtyard to perform the walking exercise program . Before each session, the patients’ vital signs including blood pressure, pulse and respiratory rate were measured by the researcher. The patients were assigned to the group of males and females to facilitate the implementation of the walking exercise program in each gender group. Similar to the intervention by Wenzel et al. (2013), the patients were asked to perform a 30-minute walk program in two 5-day non-stop periods and within a specified time each day in the following phases: warm-up and preparing the body (5 minutes), a fast-paced walking on the basis of their tolerance (10 minutes), slow-paced walking and body cooling (5 minutes) followed by 10 minutes of rest and relaxation. The patients walked slowly in the warm-up phase and took deep breathing and then entered the main walking program including a 10-minute quick-paced walking. Subsequently, the patients were asked to walk in a slow pace to feel their heartbeat and do cool down exercises for 5 minutes. After the walking exercise program, the patient laid on the bed and breathed deeply for ten minutes, and their vital signs were measured again by the researcher. In the fifth day and tenth day of the intervention, the BFI was completed again..</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:
A portion of the original outcome data is shared

When:
Starting the access period from 2020

To whom:
The data will only be available to academic researchers

Conditions:
Requests for doing a systematic review and meta-analysis of data are available

Where to obtain:
Contact  the email of the author

How to obtain:
It takes about one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>shahram baraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>school of nursing and midwiferry, Ahvaz Jundishapur University of Medical sciences, Golestan Blvd, University square,Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>88611135700</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>shahrambaraz@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahram Baraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>school of nursing and midwiferry, Ahvaz Jundishapur University of Medical sciences, Golestan Blvd, Daneshgah square,Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>88611135700</zip>
        <telephone>+98 61 3373 8333</telephone>
        <email>shahrambaraz@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>being 18 years old and over
being diagnosed with acute AML or the recurrence of AML
taking part in at least two chemotherapy sessions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of underlying diseases including cardiovascular diseases, diabetes mellitus and hypertension and any other cancers
Inability to attend walking tours
Unstable hemodynamic status
Hospital discharge or death
Life expectancy less than a month
Uncontrollable pain</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C92.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myeloblastic leukemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The researcher provided a quiet and private place in the hospital’s courtyard to perform the walking exercise program . Before each session, the patients’ vital signs including blood pressure, pulse and respiratory rate were measured by the researcher. The patients were assigned to the group of males and females to facilitate the implementation of the walking exercise program in each gender group. Similar to the intervention by Wenzel et al. (2013), the patients were asked to perform a 30-minute walk program in two 5-day non-stop periods and within a specified time each day in the following phases: warm-up and preparing the body (5 minutes), a fast-paced walking on the basis of their tolerance (10 minutes), slow-paced walking and body cooling (5 minutes) followed by 10 minutes of rest and relaxation. The patients walked slowly in the warm-up phase and took deep breathing and then entered the main walking program including a 10-minute quick-paced walking. Subsequently, the patients were asked to walk in a slow pace to feel their heartbeat and do cool down exercises for 5 minutes. After the walking exercise program, the patient laid on the bed and breathed deeply for ten minutes, and their vital signs were measured again by the researcher. In the fifth day and tenth day of the intervention, the BFI was completed again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score obtained from The Brief Fatigue Questionnaire (BFI). Timepoint: Fatigue measurement at the beginning of the study, 5 and 10 days after the planned walking. Method of measurement: The Brief Fatigue Questionnaire (BFI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fatigue interference with everyday life activities. Timepoint: Before the intervention, 5 and 10 days after the intervention. Method of measurement: The Brief Fatigue Questionnaire (BFI).</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-03</approval_date>
        <contact_name>Ethics committee of Jundishapur University of Medical Sciences</contact_name>
        <contact_address>School of nursing and midwiferry, Ahvaz Jundishapur University of Medical sciences, Golestan Blvd, Daneshgah square,Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
