<?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>IRCT20220504054733N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-09</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of lifestyle education on the quality of life of dialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of lifestyle educational interventions on quality of life of patients undergoing hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63352</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: First, according to the medical record, from all patients, people who are eligible to enter the study will be selected. Then, according to the phone number listed in the patient's file, they will be contacted gradually to provide them with the necessary explanations about the study plan and confirm the desire of people to participate in the project. Contact people until completion. The number of samples will continue. After completing the number of samples, by simple randomization method by random number table, people will be placed in intervention or control groups, Blinding description: After fully explaining the plan, how to do it and its purpose to the participants and obtaining informed consent will be randomly placed in the intervention and control groups. Also, data collection by a trained person who will be blind to the intervention and control groups Was to be accepted.</study_design>
      <phase>N/A</phase>
      <hc_freetext>renal failure, hemodialysis.</hc_freetext>
      <i_freetext>The intervention is in the form of exercises related to a healthy lifestyle for the intervention group, which will be done in 6 sessions of 30 minutes face to face with questions and answers in the patient's bed and during hemodialysis twice a week. The content of the sessions will be on topics such as diet, physical activity, a sense of responsibility for personal health, attention to spiritual growth and self-sufficiency, interpersonal relationships and stress management. The content of the meetings will be as follows.                                                                                                           Session 1: Communicating between people, the importance and necessity of a healthy lifestyle in everyday life                                                                 Session 2: Lifestyle education and its components, review of factors affecting lifestyle and self-management education                                          Session 3: Training on the effect of nutrition on health with the cooperation of a nutritionist, familiarity with the food pyramid, training on food calories and their impact on health and explaining meals and snacks Session 4: Review and training of exercises that affect health with the cooperation of a physical education expert and explain the importance of exercise in the prevention of various diseases and even in the treatment of some diseases                                                                                                 Session 5: Familiarity with the role of sleep and adequate rest in health and the introduction of correct patterns of sleep hygiene, relaxation training, concentration and positive mental imagery to affect the improvement of disease Time management training, stress management  Session 6: Summarizing and reviewing the contents.                                                 At the end of the sessions, individuals in both groups will be followed for 12 weeks to ensure the application of the training given by the intervention group and no specific changes in the lifestyle of the control group. Follow-up will be done in the form of a phone call..</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soraya Soheili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No31, narmak 1, kashani Ave</address>
        <city>Marand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5413633536</zip>
        <telephone>+98 41 4229 2236</telephone>
        <email>soraya.soheili@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soraya Soheili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No31, narmak1, kashani Ave</address>
        <city>Marand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5413633536</zip>
        <telephone>0098 41 4222936</telephone>
        <email>soraya.soheili@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 65 years
Dialysis history of at least one year</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No mental illness
Physical-motor disability
Unwillingness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention is in the form of exercises related to a healthy lifestyle for the intervention group, which will be done in 6 sessions of 30 minutes face to face with questions and answers in the patient's bed and during hemodialysis twice a week. The content of the sessions will be on topics such as diet, physical activity, a sense of responsibility for personal health, attention to spiritual growth and self-sufficiency, interpersonal relationships and stress management. The content of the meetings will be as follows.                                                                                                           Session 1: Communicating between people, the importance and necessity of a healthy lifestyle in everyday life                                                                 Session 2: Lifestyle education and its components, review of factors affecting lifestyle and self-management education                                          Session 3: Training on the effect of nutrition on health with the cooperation of a nutritionist, familiarity with the food pyramid, training on food calories and their impact on health and explaining meals and snacks Session 4: Review and training of exercises that affect health with the cooperation of a physical education expert and explain the importance of exercise in the prevention of various diseases and even in the treatment of some diseases                                                                                                 Session 5: Familiarity with the role of sleep and adequate rest in health and the introduction of correct patterns of sleep hygiene, relaxation training, concentration and positive mental imagery to affect the improvement of disease Time management training, stress management  Session 6: Summarizing and reviewing the contents.                                                 At the end of the sessions, individuals in both groups will be followed for 12 weeks to ensure the application of the training given by the intervention group and no specific changes in the lifestyle of the control group. Follow-up will be done in the form of a phone call.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>سطح کیفیت زندگی بیماران تحت همودیالیز بر اساس پرسشنامه کیفیت زندگی بیماران دیالیزی. Timepoint: Measurement of quality of life before and 12 weeks after the intervention in the intervention and control groups. Method of measurement: Quality of life questionnaire for dialysis patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lifestyle score. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Walker Health Promoting Lifestyle Questionnaire.</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, Marand Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-07</approval_date>
        <contact_name>Islamic Azad University-Tabriz Branch (Research Ethics Committee)</contact_name>
        <contact_address>No 31,narmak 1,kashani Ave Marand East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
