<?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>IRCT20191221045846N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-11</date_registration>
      <primary_sponsor>Rehmatul-Lil-Alameene Post Graduate  Institute of Cardiology</primary_sponsor>
      <public_title>Role of advising exercises using mobile health in treatment of knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of lower limb rehabilitation protocol using mobile health on physical disability and exercise adherence among knee osteoarthritis (OA) patients who are overweight and obese.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44383</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random technique by computer number generator, Blinding description: Four research coordinators will be involed in data collection. The two coordinators will be involved in baseline data collection and two coordinators will be invoved in the assessment of outcomes.Participants will be blinded of other group interventions by calling them on different days.</study_design>
      <phase>3</phase>
      <hc_freetext>Osteoarthritis of knee.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 (LLRPw-mHeath): It will consist of strengthening exercises of the lower limbs in sitting and lying positions and instructions of daily care. The training session of strengthening exercises will be of 30-40 minutes with 10 minutes warm up at the start and 10 minutes cooling down at the end. It will consist of three times a week for 12 weeks at their houses. The reminder in the form of mobile health (periodic manual WhatApp messages) will be send to carry on the training sessions. The messages will be send two times a day for three days a week for a duration of 12-weeks as a reminder. Intervention 2: Intervention group 2 (LLRPwo-mHealth): It will consist of strengthening exercises of the lower limbs in sitting and lying positions and instructions of daily care. The training session of strengthening exercises will be of 30-40 minutes with 10 minutes warm up at the start and 10 minutes cooling down at the end. It will consist of three times a week for 12 weeks at their houses. No reminder will be send by using mobile health in this intervention. Intervention 3: Control group: It will consist of instructions of daily care only as a usual care for duration of 12 weeks at their houses. No reminder will be send by using mobile health in this intervention.</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 Principal investigator doesn't allow.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Tariq Rafiq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehmatul-Lil-Alameene Post Graduate  Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 99330101</telephone>
        <email>drtariqrafiq149@yahoo.com</email>
        <affiliation>Rehmatul-Lil-Alameene Post Graduate  Institute of Cardiology</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Shariff A Hamid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports Medicine Department, University of Malaya Medical Centre, Kuala Lumpur, Malaysia</address>
        <city>Kuala Lumpur</city>
        <country1>Malaysia</country1>
        <zip>59100</zip>
        <telephone>+60 3-7967 6669</telephone>
        <email>ayip@um.edu.my</email>
        <affiliation>University of Malaya</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Overweight and obese Knee OA patients
Both males and females
Aged between 45 to 60 years
Living in urban area of Punjab, Lahore,</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>System lupus erythematosus (SLE)
Previous surgery of knee/s of any cause
Flat feet
Spinal deformities
Participants having history of metabolic, hormonal, orthopaedic, cardiovascular diseases
The patients who had any injections of knee/s in the last six months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 (LLRPw-mHeath): It will consist of strengthening exercises of the lower limbs in sitting and lying positions and instructions of daily care. The training session of strengthening exercises will be of 30-40 minutes with 10 minutes warm up at the start and 10 minutes cooling down at the end. It will consist of three times a week for 12 weeks at their houses. The reminder in the form of mobile health (periodic manual WhatApp messages) will be send to carry on the training sessions. The messages will be send two times a day for three days a week for a duration of 12-weeks as a reminder.</i_keyword>
      <i_keyword>Intervention group 2 (LLRPwo-mHealth): It will consist of strengthening exercises of the lower limbs in sitting and lying positions and instructions of daily care. The training session of strengthening exercises will be of 30-40 minutes with 10 minutes warm up at the start and 10 minutes cooling down at the end. It will consist of three times a week for 12 weeks at their houses. No reminder will be send by using mobile health in this intervention.</i_keyword>
      <i_keyword>Control group: It will consist of instructions of daily care only as a usual care for duration of 12 weeks at their houses. No reminder will be send by using mobile health in this intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical disability. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Composite Indian Functional Knee Assessment Scale (CIFKAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Exercise adherence. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Numeric rating scale from 0 to 10.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>University of Malaya</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Rehmatul-Lil-Alameene Post Graduate  Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore</source_name>
      <source_name>University of Malaya, Kuala Lumpur, Malaysia</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-28</approval_date>
        <contact_name>Ethical Committee Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology, Punjab Employees Soci</contact_name>
        <contact_address>Rehmatul-Lil-Alameene Post Graduate  Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road, Lahore, Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
