<?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>IRCT20230308057656N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-11</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the Effect of using Easy Workout Kit on Hemodialysis outcomes</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of using Easy Workout Kit on Hemodialysis outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69460</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: using Easy Workout Kit.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic kidney disease.</hc_freetext>
      <i_freetext>Easy exercise packages that include (hexagonal weight, wrist strengthening ring, pilates stretch, stretch loop) will be prepared and then referred to the dialysis department of Baqiyatollah Hospital and according to the sample size (number of 45 people) by sampling in Subjects will be selected. Before starting the intervention, basic information will be collected from the subjects using demographic questionnaires. An informed satisfaction questionnaire will be taken from the study subjects. Adequacy of dialysis will be evaluated using blood biochemical tests (URR, KT/V, P, Ca, Na, K, PTH, HCo3-, and Plt) before the intervention. The sleep quality of the patients will be evaluated using Richard Campbell's sleep quality questionnaire. The quality of life of patients will be evaluated using the questionnaire of the quality of life of kidney patients. The demographic questionnaire has questions about age, sex, marital status, duration of hemodialysis in months, education, occupation, effect of treatment on employment status, type of vascular access, cause of kidney failure and presence of stress in the past six months, and questions about willingness to exercise regularly. Was. Questionnaire and evaluations will be taken before and after the test. First, the exercises are selected according to the patient's physical, physical condition, and ability, with the diagnosis of the sports physiologist, which exercises during dialysis: plastic ring: 3 sets of pressing the ring until disability and dumbbell: dumbbell forearm 3 sets of disability, dumbbell side push 3 sets of disability, Front dumbbell 3 sets of disability and stretch loop: leg abduction 3 sets of disability, front thigh 3 sets of disability and Pilates stretch, back of arm stretch 3 sets of disability, money maker 3 sets of disability that 1 set is added to the exercises every 2 weeks, up to a maximum of 5 sets at the end and rest There is at least 1 minute between the sets, and before starting the work sets, they warm up the muscles with 2 sets without weights and stretching. The duration of the intervention is 12 weeks, so that exercises will be performed 3 times per week during dialysis. Before starting to exercise, the patient will be discussed with him in relation to movement restrictions in order to choose the most suitable exercise for him in case of shortness of breath, increased heart rate, chest pain, irregular heartbeat, pain and muscle cramps, nausea, dizziness and Blurred vision to stop exercise. Exercises will start after half an hour from the start of dialysis and stability of the patient's vital signs. At the end of every month, in the final minutes of hemodialysis and before separating the patient from the machine, the pump will be adjusted to fifty milliliters per minute and a blood sample will be taken from the arterial set. Blood sampling will be done using an arterial needle before the injection of normal saline and heparin and in the last ten minutes of dialysis and will be sent to the hospital laboratory. After the last day of the intervention, on the final day, blood sampling will be done again to assess dialysis adequacy, Richard Campbell questionnaire to assess sleep quality and KDQOL-SFTM questionnaire to assess quality of life will be measured as a post-test..</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Tayebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, No. 26, South Sheikh Bahaei St., Mollasadra Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8248 3502</telephone>
        <email>tayybi.ali@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Tayebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, No. 26, South Sheikh Bahaei St., Mollasadra Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915741</zip>
        <telephone>+98 21 8248 3502</telephone>
        <email>tayybi.ali@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The subjects of the research will include 45 hemodialysis patients of the dialysis department of Baqiyat Allah Hospital, with an age range of 30 to 80 years and with a duration of dialysis of more than 1 year.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of special diseases such as cardiovascular diseases, cognitive disorders, arthritis, special diseases that prevent a person from physical activity.</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Easy exercise packages that include (hexagonal weight, wrist strengthening ring, pilates stretch, stretch loop) will be prepared and then referred to the dialysis department of Baqiyatollah Hospital and according to the sample size (number of 45 people) by sampling in Subjects will be selected. Before starting the intervention, basic information will be collected from the subjects using demographic questionnaires. An informed satisfaction questionnaire will be taken from the study subjects. Adequacy of dialysis will be evaluated using blood biochemical tests (URR, KT/V, P, Ca, Na, K, PTH, HCo3-, and Plt) before the intervention. The sleep quality of the patients will be evaluated using Richard Campbell's sleep quality questionnaire. The quality of life of patients will be evaluated using the questionnaire of the quality of life of kidney patients. The demographic questionnaire has questions about age, sex, marital status, duration of hemodialysis in months, education, occupation, effect of treatment on employment status, type of vascular access, cause of kidney failure and presence of stress in the past six months, and questions about willingness to exercise regularly. Was. Questionnaire and evaluations will be taken before and after the test. First, the exercises are selected according to the patient's physical, physical condition, and ability, with the diagnosis of the sports physiologist, which exercises during dialysis: plastic ring: 3 sets of pressing the ring until disability and dumbbell: dumbbell forearm 3 sets of disability, dumbbell side push 3 sets of disability, Front dumbbell 3 sets of disability and stretch loop: leg abduction 3 sets of disability, front thigh 3 sets of disability and Pilates stretch, back of arm stretch 3 sets of disability, money maker 3 sets of disability that 1 set is added to the exercises every 2 weeks, up to a maximum of 5 sets at the end and rest There is at least 1 minute between the sets, and before starting the work sets, they warm up the muscles with 2 sets without weights and stretching. The duration of the intervention is 12 weeks, so that exercises will be performed 3 times per week during dialysis. Before starting to exercise, the patient will be discussed with him in relation to movement restrictions in order to choose the most suitable exercise for him in case of shortness of breath, increased heart rate, chest pain, irregular heartbeat, pain and muscle cramps, nausea, dizziness and Blurred vision to stop exercise. Exercises will start after half an hour from the start of dialysis and stability of the patient's vital signs. At the end of every month, in the final minutes of hemodialysis and before separating the patient from the machine, the pump will be adjusted to fifty milliliters per minute and a blood sample will be taken from the arterial set. Blood sampling will be done using an arterial needle before the injection of normal saline and heparin and in the last ten minutes of dialysis and will be sent to the hospital laboratory. After the last day of the intervention, on the final day, blood sampling will be done again to assess dialysis adequacy, Richard Campbell questionnaire to assess sleep quality and KDQOL-SFTM questionnaire to assess quality of life will be measured as a post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality score in Richard Campbell questionnaire. Timepoint: Before and after the intervention. Method of measurement: Richard Campbell Questionnaire.</prim_outcome>
      <prim_outcome>Quality of life score with KDQOL-SFTM questionnaire. Timepoint: Before and after the intervention. Method of measurement: KDQOL-SFTM questionnaire.</prim_outcome>
      <prim_outcome>Dialysis adequacy using blood biochemical tests (URR, KT/V, P, Ca, Na, K, PTH, HCo3-, and Plt). Timepoint: Before and after the intervention. Method of measurement: Dialysis adequacy using blood biochemical tests (URR, KT/V, P, Ca, Na, K, PTH, HCo3-, and Plt).</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-26</approval_date>
        <contact_name>Ethics committee of Baqiatallah medical of sciences University</contact_name>
        <contact_address>Baqiyatallah University of Medical Sciences, No. 26, South Sheikh Bahaei St., Mollasadra Ave., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
