<?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>IRCT20230427058007N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-14</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Effect of weight bearing functional exercises and non-weight bearing quadriceps strengthening along with breathing exercises in people with knee osteoarthritis and obesity.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of weight bearing functional exercises and non-weight bearing quadriceps strengthening along with breathing exercises on pain, functional activity, stress, lipid profile , cellular hypoxia and BDNF levels in people with knee osteoarthritis and obesity.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70009</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: No, Randomization description: Even Odd method was used for Randomization. even group numbers was enrolled  as group A and odd group numbers was enrolled as Group B, Blinding description: The care provider was blinded to the groups of the study as well as the outcome Accessor was also blinded to the treatment protocols and study hypothesis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: non weight bearing quardiceps strengthening exercises along with breathing exercises for 6 weeks. Each session will last 30–40 min. Participants will be provided with adjustable ankle cuff weights (0.65 kg to 10 kg) and elastic resistance bands. They will commence the program with two sets of ten repetitions for each exercise for the first 2 weeks and progress to three sets thereafter or as quickly as able. The starting weight will be the participant’s 10-repetition maximum weight or determined by the participant’s level of effort aiming for between 5 and 8 out of 10 (hard to very hard) on the modified Borg Rating of Perceived Exertion CR-10 scale for strength training . Intervention 2: Intervention group 2: weight bearing functional exercises along with breathing exercises for 6 weeks.  Each session will last 30–40 min. . Participants will be provided with an adjustable step (10 cm to 15 cm height), foam mat, and elastic resistance bands. A major emphasis is on the quality of performance of each exercise. Participants will be instructed to maintain alignment of the pelvis and trunk in the frontal plane (avoid pelvic drop and trunk lateral flexion) and to neutrally align their knee (position the knee over the foot as much as possible) throughout the movements. Knee flexion should not exceed 30° (except when performing the chair stand exercise) to reduce the risk of increasing knee pain. Having hand support within easy reach or using hand support is important for maintaining balance and quality of performance throughout the movements. Exercise progression is essential and  is determined by the physiotherapist, based on a combination of the participant’s pain and rating of perceived exertion score for each exercise (at least 5 out of 10 on a modified Borg Rating of Perceived Exertion CR-10 scale) and the physiotherapist’s assessment of the quality of the exercise performance.</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 we have recruited the data and completed the trial because things have to be streamline later</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muzna Munir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>249 - Johar town, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>53710</zip>
        <telephone>+92 334 4265125</telephone>
        <email>muznafmh@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muzna Munir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>249 - Johar town, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>53710</zip>
        <telephone>+92 334 4265125</telephone>
        <email>muznafmh@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Are aged 40 to 60 years
Both genders
Have had knee pain for 3 months or more
Report a minimum of 3 overall pain severity on 11-point numeric rating scale (NPRS)
Demonstrate tibiofemoral osteophytes on x-ray</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lateral joint space narrowing greater than or equal to medial joint space narrowing on x-ray according to a radiographic atlas
Knee surgery/joint injection in past 6 months or planned surgery in the next 9 months
Current or past (4 weeks) oral corticosteroids use
Systemic arthritic conditions
Past knee fracture or malignancy
Past hip/knee joint replacement/tibial osteotomy
Unable to walk unaided</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: non weight bearing quardiceps strengthening exercises along with breathing exercises for 6 weeks. Each session will last 30–40 min. Participants will be provided with adjustable ankle cuff weights (0.65 kg to 10 kg) and elastic resistance bands. They will commence the program with two sets of ten repetitions for each exercise for the first 2 weeks and progress to three sets thereafter or as quickly as able. The starting weight will be the participant’s 10-repetition maximum weight or determined by the participant’s level of effort aiming for between 5 and 8 out of 10 (hard to very hard) on the modified Borg Rating of Perceived Exertion CR-10 scale for strength training .</i_keyword>
      <i_keyword>Intervention group 2: weight bearing functional exercises along with breathing exercises for 6 weeks.  Each session will last 30–40 min. . Participants will be provided with an adjustable step (10 cm to 15 cm height), foam mat, and elastic resistance bands. A major emphasis is on the quality of performance of each exercise. Participants will be instructed to maintain alignment of the pelvis and trunk in the frontal plane (avoid pelvic drop and trunk lateral flexion) and to neutrally align their knee (position the knee over the foot as much as possible) throughout the movements. Knee flexion should not exceed 30° (except when performing the chair stand exercise) to reduce the risk of increasing knee pain. Having hand support within easy reach or using hand support is important for maintaining balance and quality of performance throughout the movements. Exercise progression is essential and  is determined by the physiotherapist, based on a combination of the participant’s pain and rating of perceived exertion score for each exercise (at least 5 out of 10 on a modified Borg Rating of Perceived Exertion CR-10 scale) and the physiotherapist’s assessment of the quality of the exercise performance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: base line and after 6 weeks. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: base line and after 6 weeks. Method of measurement: The Western Ontario and McMaster universities Arthritis Index.</prim_outcome>
      <prim_outcome>Brain Derived Neurotrophic levels levels. Timepoint: base line and after 6 weeks. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: base line and after 6 weeks. Method of measurement: Arterial blood gases.</prim_outcome>
      <prim_outcome>Stress, Anxiety &amp; Depression. Timepoint: base line and after 6 weeks. Method of measurement: Depression Anxiety and Stress Scale.</prim_outcome>
      <prim_outcome>HDL and LDL. Timepoint: base line and after 6 weeks. Method of measurement: Lipid profile.</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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-08</approval_date>
        <contact_name>Research &amp; Ethics Committee</contact_name>
        <contact_address>Riphah College of Rehabilitation and allied health sciences, QIE campus Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
