<?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>IRCT2017100218117N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-19</date_registration>
      <primary_sponsor>Vice chancellor for research, Bushehr University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Home-based Rehabilitation on the Treatment of Knee Qsteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Home-based Rehabilitation Ttraining on Pain, Performance, General Health and Quality of Life in Patients with Knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16522</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group: Implementation of three 1-hour sessions "Individual training and practice in the following order:&#13;
The first training session on knee osteoarthritis, the causes of symptoms, symptoms, and a simple language diet for one hour is explained.&#13;
The second session is about the pharmaceutical diet, proper sitting and lifting, and the patient is asked to practice in the presence of the researcher in order to ensure that it is accurate.  The third session is about exercising and Range of Motion (ROM) exercises, and the patient is required to perform exercises in the presence of a researcher in order to ensure that it is accurate. Also, a review of the two sessions is done and the questions are answered to the patient and will be provided to the patients at the end of the session on the educational curriculum related to the training sessions. The patient is then asked to repeat the stretching exercises on a daily basis and how to sit up and get up and keep up-to-date, and complete all the training tips and exercises for two months, and a checklist of hints and exercises that should be done throughout the day.  He will be given a mark on them.  The checklist is also available to the researcher, and the researcher will contact the patient once a week to ensure that he or she is practicing and observing educational issues". Intervention 2: "The control group: does not receive rehabilitation training and receive routine therapies.".</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Hosseinabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences, Rishahr St, Bushehr, Iran.</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 77 3345 0084</telephone>
        <email>Hosseinabadz374@gmail.com</email>
        <affiliation>Bushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Jokar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences, Rishahr St, Bushehr, Iran.</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0084</telephone>
        <email>Z.Jokar@bpums.ac.ir;Aram.jokar@gmail.com</email>
        <affiliation>Bushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: No history of surgical related disease (such as joint replacement, joint repair), having radiological symptoms of osteoarthritis in knee with a physician's approval, non-use of an intra-articular injectable drug, the absence of any mental and psychological illness according to the patient's own statements, and  independence in self-care.&#13;
Exclusion criteria: The first referral of the patient and the lack of diagnosis by the doctor, the lack of regular referral of the patient, the patient's reluctance to continue treatment, and exacerbation of symptoms.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>[Gonarthrosis [arthrosis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group: Implementation of three 1-hour sessions "Individual training and practice in the following order:&#13;
The first training session on knee osteoarthritis, the causes of symptoms, symptoms, and a simple language diet for one hour is explained.&#13;
The second session is about the pharmaceutical diet, proper sitting and lifting, and the patient is asked to practice in the presence of the researcher in order to ensure that it is accurate.  The third session is about exercising and Range of Motion (ROM) exercises, and the patient is required to perform exercises in the presence of a researcher in order to ensure that it is accurate. Also, a review of the two sessions is done and the questions are answered to the patient and will be provided to the patients at the end of the session on the educational curriculum related to the training sessions. The patient is then asked to repeat the stretching exercises on a daily basis and how to sit up and get up and keep up-to-date, and complete all the training tips and exercises for two months, and a checklist of hints and exercises that should be done throughout the day.  He will be given a mark on them.  The checklist is also available to the researcher, and the researcher will contact the patient once a week to ensure that he or she is practicing and observing educational issues".</i_keyword>
      <i_keyword>"The control group: does not receive rehabilitation training and receive routine therapies."</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Visual Scale of Pain.</prim_outcome>
      <prim_outcome>Performance. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Scale KOOS.</prim_outcome>
      <prim_outcome>General health. Timepoint: Before the intervention, two months after the intervention. Method of measurement: General Health Questionnaire.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Quality of Life Questionnaire (SF-36).</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>Vice chancellor for research, Bushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-27</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Rishehr St,Bushehr, Iran Bushehr  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
