<?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>IRCT20230312057690N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-17</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of isometric and isotonic hand exercises on AVF maturation in patients with chronic renal failure</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of isometric and isotonic hand exercises on AVF maturation in patients with chronic renal failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69166</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the random numbers table, the participants will be recruited into the control and intervention groups. For this purpose, the researchers give a code to the members of the community, and since the number of members of the community is two digits, they give a two-digit code. Then they randomly start from a table point in the row direction. According to the type of digits of the codes (two digits), they will select the same number of digits in the direction of the table row. After reaching the desired house, they will choose a number smaller than the number of the population under study. The selected number is actually the code of an individual from the community that is selected as a sample. This work should continue until the number of sample people can be selected, Blinding description: The analyzer of the outcomes will not be informed about the treatment assignments, this means that when presenting the data to her/him, the questionnaires have only one number and it is not clear which group each of these questionnaires belong to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>ESRD.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Isometric exercises: It will be designed by a sports medicine specialist. This exercise program starts in the department under the supervision of a doctor 2 days after surgery and should be continued four times a day for 3 days a week. This exercise program starts with a low intensity 4 times a day (2 times in the morning and 2 times in the evening) in the form of pressing a tennis ball and exercising with dumbbells (half to one kilogram) and pulling bands, and the intensity of these exercises will increase in the following days. Intervention 2: Intervention group2: Isotonic exercises: It will be done using a wrist strengthening spring and a wrist strengthening ring approved by a doctor and sports medicine specialist. In these patients, two days after the surgery, sports are started under the supervision of a doctor. In this way, in the first week, the patients are asked to squeeze and open the wrist strengthening ring 10 to 30 times per minute and repeat this 6 times a day, leaving at least 90 seconds between each set. In the 2nd week, the same thing should be done with the wrist strengthening spring, and in the 3rd and 4th weeks, each set will be increased to a minute. Intervention 3: Control group: After surgery, they receive general training such as not to do hard work, not to take blood and blood pressure samples from the hand, and to do exercise using a plastic ball. This group performs the exercises 10 times, rests for one minute, and again ten times, rests for one minute, and presses the ball ten times for the third time. This group is asked to do this twice in the morning and twice in the evening. If there are no signs of infection, abscess, inflammation, pain and tenderness in the surgery site, these exercises will start 24 hours after the surgery.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is ethical considerations</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zinat Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7168783399</zip>
        <telephone>+98 71 3647 4255</telephone>
        <email>azita635@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azita Jaberi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7168783399</zip>
        <telephone>+98 71 3647 4255</telephone>
        <email>azita635@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>diagnosed with ESRD
AVF done for the first time
18 years old and older</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 4 (severe)</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 group1: Isometric exercises: It will be designed by a sports medicine specialist. This exercise program starts in the department under the supervision of a doctor 2 days after surgery and should be continued four times a day for 3 days a week. This exercise program starts with a low intensity 4 times a day (2 times in the morning and 2 times in the evening) in the form of pressing a tennis ball and exercising with dumbbells (half to one kilogram) and pulling bands, and the intensity of these exercises will increase in the following days.</i_keyword>
      <i_keyword>Intervention group2: Isotonic exercises: It will be done using a wrist strengthening spring and a wrist strengthening ring approved by a doctor and sports medicine specialist. In these patients, two days after the surgery, sports are started under the supervision of a doctor. In this way, in the first week, the patients are asked to squeeze and open the wrist strengthening ring 10 to 30 times per minute and repeat this 6 times a day, leaving at least 90 seconds between each set. In the 2nd week, the same thing should be done with the wrist strengthening spring, and in the 3rd and 4th weeks, each set will be increased to a minute.</i_keyword>
      <i_keyword>Control group: After surgery, they receive general training such as not to do hard work, not to take blood and blood pressure samples from the hand, and to do exercise using a plastic ball. This group performs the exercises 10 times, rests for one minute, and again ten times, rests for one minute, and presses the ball ten times for the third time. This group is asked to do this twice in the morning and twice in the evening. If there are no signs of infection, abscess, inflammation, pain and tenderness in the surgery site, these exercises will start 24 hours after the surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>AVF maturation. Timepoint: before and after intervention. Method of measurement: Ultrasonography and physical exam.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-21</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>أamazi square shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
