<?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>IRCT20220809055648N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of vision, balance and combined exercises on motor function and quality of life of hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of vision, balance and combined exercises on motor function and quality of life of hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66451</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Simple randomization, individual with random number generation program
Randomization was performed by a biostatistician using a computer-generated randomization program [using Stata 16, StataCrop, College Station, Tx] (regarding number of groups) with an allocation ratio of 1:1:1:1.
For allocation concealment, allocation information will be protected in opaque sealed envelopes by an identified individual not participating in the study. Only after participant registration and baseline measurements are completed will envelopes be opened, Blinding description: Due to the nature of the intervention, it is not plausible to blind participants and study staff
who enroll participants and monitor the intervention delivery.
Research project collaborator who is blinded to
study arm assignments will obtain outcome measurements of the functional test and abnormalities. Outcome
adjudicators, and data analysts will be kept blinded to the allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>End stage renal disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group of balance exercises, three sessions per week for 12 weeks ( each for 1 hour) includes stretching exercises (neck stretching, arm and hand stretching, shoulder rotation and vertical movement, lateral stretching, single knee stretching, leg stretching) which Taken from Pinter's studies at the Medical Education Institute, it is an empowering resource. and balance exercises taken from the studies of Bennett, Lingard and Maxwell (2015), which include (chest press, shoulder press, triceps strengthening, straight arm stretch, horizontal shoulder stretch, back grip, palmar grip, biceps rotation, rotation leg press, calf press, leg press in a straight position, leg press in bent knee position, hip pull, straight leg lift, drawing letters with feet in the air, pulling knees in the stomach). Intervention 2: The vision training group, which has three sessions (each for 1 hour) per week for 12 weeks, will do vision exercise which includes saccadic eye movements and tracking. Intervention 3: Intervention group: Combined exercises for 12 weeks, three sessions per week (  each for 1 hour). The participants will do balance and vision exercises ( each one for half an hour). Intervention 4: Control group: without exercising.</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 results of the study group are made available

When:
ِِAfter November 2023

To whom:
Only academics are allowed.

Conditions:
If the data is used for the purpose of research in the field of variables and providing new solutions, it can be used by mentioning the source.

Where to obtain:
by email
m.h.sarbazi@gmail.com
rokhsareh.badami@gmail.com
zmeshkati@gmail.com
be referred.

How to obtain:
It will be answered within one month after receiving the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahbobeh Hosseini Sarbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd, Arghavanieh Ave, Estern Jey Str, Esfahan Town</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>m.h.sarbazi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rokhsare Badami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd, Arghavanieh Ave, Estern Jey Str, Esfahan Town</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>rokhsareh.badami@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 80 years
More than 1 year of dialysis experience
Having a three-time hemodialysis program
No heart attack and stroke in the past three months
Having the ability to communicate with others
The permission of the attending physician to practice</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>unstable heart condition (angina, congestive heart failure, severe arterial stenosis) during exercise
Active infection or acute medical illness during intervention
Hemodynamic instability during intervention
Unstable blood sugar during intervention
Unable to do exercises, after a few sessions of participating
Having severe musculoskeletal pain during exercises</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>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The group of balance exercises, three sessions per week for 12 weeks ( each for 1 hour) includes stretching exercises (neck stretching, arm and hand stretching, shoulder rotation and vertical movement, lateral stretching, single knee stretching, leg stretching) which Taken from Pinter's studies at the Medical Education Institute, it is an empowering resource. and balance exercises taken from the studies of Bennett, Lingard and Maxwell (2015), which include (chest press, shoulder press, triceps strengthening, straight arm stretch, horizontal shoulder stretch, back grip, palmar grip, biceps rotation, rotation leg press, calf press, leg press in a straight position, leg press in bent knee position, hip pull, straight leg lift, drawing letters with feet in the air, pulling knees in the stomach).</i_keyword>
      <i_keyword>The vision training group, which has three sessions (each for 1 hour) per week for 12 weeks, will do vision exercise which includes saccadic eye movements and tracking.</i_keyword>
      <i_keyword>Intervention group: Combined exercises for 12 weeks, three sessions per week (  each for 1 hour). The participants will do balance and vision exercises ( each one for half an hour).</i_keyword>
      <i_keyword>Control group: without exercising</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor performance. Timepoint: Before starting exercise and three months later. Method of measurement: 6-minute walk test, Berg balance test, Timed up and Go test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Before starting exercise and three months later. Method of measurement: The standard questionnaire of the quality of life for kidney patients.</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>Islamic Azad University of Khorasgan, Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-14</approval_date>
        <contact_name>Ethics Committee of Azad University of Khorasgan Branch</contact_name>
        <contact_address>University Blvd, Arghavanieh Ave, Estern Jey Str, Esfahan Town Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
