<?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>IRCT20241125063851N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-04</date_registration>
      <primary_sponsor>University of Kerbala</primary_sponsor>
      <public_title>Effect Legs Strength Exercises on Activities of Daily Living, Physical Fitness and Fatigue Level in Patients undergoing Hemodialysis: Clinical Trial</public_title>
      <acronym>HD, ADLs</acronym>
      <scientific_title>Effect of Legs Strength Exercises on Activities of Daily Living, Physical Fitness, and Fatigue Level in Patients undergoing Hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80562</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the exercises began on the first day of the 4th week of hemodialysis therapy, each exercise session lasted for 25 minutes and was conducted during the first 2 hours of the dialysis sessions. Intervention 2: Control group: these patients take the routine nursing care just without intervention.</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:
The data will be the results of the Bristol Activities of Daily living Scale, International Fitness Scale, and Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4) that measures activities daily living, physical fitness, and fatigue levels in both the control and intervention groups

When:
God Willing, once the article is published, the data will be
available after 6 months of publication. If the article will
be published in a subscribed journal, the data will be
available after one year because of the policy of the
subscribed journals.

To whom:
with academic nurses and any researcher who is
interested in the data.

Conditions:
The data could be used after getting permission via
email. Also, users need to acknowledge the owner.

Where to obtain:
Users can ask for the data and permission via email.Ilham Ghanam is the corresponding author. He will contact whoever he requests the information from. His email is ilham.g@s.uokerbala.edu.iq  Users can ask for the data and permission via email. What processes are involved for a request to access data/document What processes are involved for a request to access data/document

How to obtain:
Users can ask for the data and permission via email. Ilham Ghanam is the corresponding author. He will contact whoever he requests the information from. His email is ilham.g@s.uokerbala.edu.iq

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ilham Ghanam Jabbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Baladia district street</address>
        <city>Kerbala</city>
        <country1>Iraq</country1>
        <zip>56001</zip>
        <telephone>+964 773 070 1025</telephone>
        <email>ilham.g@s.uokerbala.edu.iq</email>
        <affiliation>University of Kerbala</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ilham Ghanam Jabbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Baladia district street</address>
        <city>Karbala</city>
        <country1>Iraq</country1>
        <zip>56001</zip>
        <telephone>+964 773 070 1025</telephone>
        <email>ilham.g@s.uokerbala.edu.iq</email>
        <affiliation>University of Kerbala</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Patients who have three and two undergoing hemodialysis sessions. 2. All patients male and female. 3. Patient have stable cardiac profiles.  4. Patients who are regular for HD sessions. 5. patients age from 18 to 60 years old.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Patients who having femoral access to HD. 2. Patients who refuse participant in the study. 3. participants in the pilot study. 4. Patients have physical disability and orthopedic problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for adequacy testing for hemodialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the exercises began on the first day of the 4th week of hemodialysis therapy, each exercise session lasted for 25 minutes and was conducted during the first 2 hours of the dialysis sessions.</i_keyword>
      <i_keyword>Control group: these patients take the routine nursing care just without intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variable is the level of activities of daily living that can be changed based legs strength exercises. Timepoint: Before intervention and four weeks after intervention. Method of measurement: The Bristol of activities daily living well be used to assess the activities of daily living.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The secondary outcome variable is the level of physical fitness that can be changed based on legs strength exercises. Timepoint: Before intervention and four weeks after intervention. Method of measurement: The International Fitness Scale will be used to assess the level of physical fitness.</sec_outcome>
      <sec_outcome>The secondary outcome variable is the level of fatigue that can be changed based on legs strength exercises. Timepoint: Before intervention and four weeks after intervention. Method of measurement: The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4) will be used to assess the level of fatigue.</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>The author of the trial is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-27</approval_date>
        <contact_name>Ethics committee in College of Nursing at University of Kerbala</contact_name>
        <contact_address>Al-Baladia district street Karbala Karbala Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
