<?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>IRCT20191221045846N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-20</date_registration>
      <primary_sponsor>Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology</primary_sponsor>
      <public_title>The role of strength training in treatment of knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>The effects of progressive resistance strength training on body mass index, quality of life and functional capacity in knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49504</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study will be single blinded randomized controlled design. The method of allocation generation will be done by a computerized random-number generator. The sequence will be generated by the process of simple randomization. Simple randomization will be based on a single sequence of random assignments.Three research coordinators will be involved in data collection. The one coordinator will be involved in baseline data collection and two coordinators will be involved in the assessment of outcomes. Participants will be blinded of other groups intervention, Blinding description: The coordinators collecting data will be independent individuals from trials and will be unaware of the group allocation. There will be different coordinators at the initial and final evaluation.  Individuals performing the statistical analysis will be blinded by labelling the groups with non-identifying terms (such as X and Y).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoarthritis of knee.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participants in the intervention group will perform the training sessions of progressive resistance strength training of lower limb muscle groups following the instructions of daily care for duration of 12-weeks. Each training session started with 10 minutes warm up, 45–60 minutes of progressive resistance strength training of lower limb muscle group,s training, and 10 minutes cool down at the end of training session. Intervention 2: Control group: The participants in the control group will follow the instructions of daily care for duration of 12-weeks. Instructions of daily care are general guidelines of eating and care of knee in order to prevent the cartilage destruction.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Tariq Rafiq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehmatul-Lil-Alamine Post Graduate  Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 99330103</telephone>
        <email>drtariqrafiq149@yahoo.com</email>
        <affiliation>Punjab Employees Social Security Institution</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 osteoarthritis patients having osteoarthritis of one or both knees
Osteoarthritis grading scale of 2-mild or 3-moderate according to Kellgren and Lawrence radiographic scale
Symptoms of osteoarthritis for more than three months
Residing in the Urban community of Lahore</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Flat feet
Knee surgery
Corticosteroid injection of knee
Spinal deformities
Cardiac problem
Hormonal problem.</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>Treatment - Other</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The participants in the intervention group will perform the training sessions of progressive resistance strength training of lower limb muscle groups following the instructions of daily care for duration of 12-weeks. Each training session started with 10 minutes warm up, 45–60 minutes of progressive resistance strength training of lower limb muscle group,s training, and 10 minutes cool down at the end of training session.</i_keyword>
      <i_keyword>Control group: The participants in the control group will follow the instructions of daily care for duration of 12-weeks. Instructions of daily care are general guidelines of eating and care of knee in order to prevent the cartilage destruction.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body Mass Index. Timepoint: At pre-test and post-test (after 12-weeks of intervention) measurements. Method of measurement: Calculated by the formula Weight (kg)/Height(meter square).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: At pre-test and post-test (after 12-weeks of intervention) measurements. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index summary score of pain, stiffness and physical function.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional capacity. Timepoint: At pre-test and post-test (after 12-weeks of intervention) measurements. Method of measurement: Gait Speed Test will be used for the assessment of functional capacity.</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>N/A</source_name>
      <source_name>N/A</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-30</approval_date>
        <contact_name>Ethical Committee RAIC PESSI (Rehmatul-Lil-Alameen Postgraduate Institute of Cardiology, Punjab Empl</contact_name>
        <contact_address>Multan Chongi Multan Road Lahore, Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
