<?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>IRCT20230409057863N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-20</date_registration>
      <primary_sponsor>Razi university</primary_sponsor>
      <public_title>Comparing the Effect of Aqua and Land Based Closed Kinetic Chain Exercises on  in Women with Osteoarthritis and Knee Instability.</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effect of Aqua and Land Based Closed Kinetic Chain Exercises on Pain, Function, Knee Instability, Proprioception, Kinesiofobia, and Quality of Life in Women with Osteoarthritis and Knee Instability.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69519</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects will be randomized based on the Random Number Generator software, and then based on the concealment of allocation by the SNOSE method, they will be divided into groups of water-based closed motion chain exercises (n=16) and land-based closed motion chain exercises (n=16). n) will be allocated. The random distribution list will be extracted from the software by a person not involved in data collection and will be provided to the laboratory expert. After evaluating each subject, by removing one of the sealed envelopes, the subject and the evaluator will be informed of the assigned group, Blinding description: In this study, since the evaluator and the subjects will be informed about the intervention groups after the evaluation of the primary and secondary outcomes, the researcher will not have any information about the exercises and interventions assigned to the groups. However, it is not possible to blind the subjects from the study interventions. It will also be possible to inform the person who will analyze the data about the groups and exercises assigned to them.</study_design>
      <phase>3</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Water-based Closed Kinetic Chain exercises:                                      The exercises will be applied by an expert certified in the field of corrective exercises and sports rehabilitation. The exercises will also be approved by a physiotherapist specializing in exercise therapy. The exercises will be performed for eight weeks, three sessions a week, and 60 minutes each week. In each session, 10 minutes of warm-up exercises (forward walking, backward walking, lateral walking, and stretching movements), 10 minutes of cooling down exercises (stretching movements) and the main exercise will last 40 minutes. The temperature of the pool for water-based closed kinetic chain exercises will be 32 degrees in a shallow environment with dimensions of 152 x 86 cm and a depth of 95 cm. Tools such as chairs, steps, weights, stretch bands, pilates balls, etc. will also be used in the implementation of study training protocols. The main program of closed kinetic chain exercises includes exercises such as mini squats, front and side step-ups, front and side step-downs, wall sliding, heel rising, lunge exercises from the front and sides, quadriceps setting exercises, and single leg mini squats. Intervention 2: Control group: Land-based-Closed Kinetic Chain exercises:                                       The exercises of both groups will be applied by an expert certified in the field of corrective exercises and sports rehabilitation. The exercises will also be approved by a physiotherapist specializing in exercise therapy. The exercises will be performed for eight weeks, three sessions a week, and 60 minutes each week. In each session, 10 minutes of warm-up exercises (forward walking, backward walking, lateral walking, and stretching movements), 10 minutes of cooling down exercises (stretching movements), and the main exercise protocol will last 40 minutes.  Tools such as chairs, steps, weights, stretch bands, pilates balls, etc. will also be used in the implementation of study training protocols. The main program of closed kinetic chain exercises includes exercises such as mini squats, front and side step-up, front and side step-downs, wall sliding, heel rising, lunge exercises from the front and sides, quadriceps setting exercises, and single leg mini squats.</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 Based on the opinion of the colleagues, after the work is done, a decision will be made for publication, and the data can be provided to the readers in order to publish the articles by emailing the responsible author.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahshid Mohammadi Darvishani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Plot 416, Block 20, Phase 2, Elkhebal St., Imam Reza Town,</address>
        <city>Kermanshah-Sahne city</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6746189180</zip>
        <telephone>+98 83 4838 1418</telephone>
        <email>mahshid.mohammadi1188@gmail.com</email>
        <affiliation>Razi University-Faculty of Sports Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Mohammadi Darvishani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Plot 416, Block 20, Phase 2, Elkhebal St., Imam Reza Town,</address>
        <city>Kermanshah city - Sahne city</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6746189180</zip>
        <telephone>+98 83 4838 1418</telephone>
        <email>mahshid.mohammadi1188@gmail.com</email>
        <affiliation>Razi University-Faculty of Sports Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>"Age over 40 years"
"Having the clinical criteria of knee osteoarthritis of the American College of Rheumatology"
"Having a score of ≤II in the Kellgern and Lawerence criteria"
"Chronic knee pain most days, for at least 3 months, a pain score of at least 4 on the analogue scale visual pain"
"reduction of joint space or osteophyte in radiography"</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>history of knee or spine surgery
Awaiting arthroplasty
Uncontrolled diabetes
History of joint injections or other complementary treatments during the last three months
Use of walking aids
Lack of balance</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary osteoarthritis of other joints</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: Water-based Closed Kinetic Chain exercises:                                      The exercises will be applied by an expert certified in the field of corrective exercises and sports rehabilitation. The exercises will also be approved by a physiotherapist specializing in exercise therapy. The exercises will be performed for eight weeks, three sessions a week, and 60 minutes each week. In each session, 10 minutes of warm-up exercises (forward walking, backward walking, lateral walking, and stretching movements), 10 minutes of cooling down exercises (stretching movements) and the main exercise will last 40 minutes. The temperature of the pool for water-based closed kinetic chain exercises will be 32 degrees in a shallow environment with dimensions of 152 x 86 cm and a depth of 95 cm. Tools such as chairs, steps, weights, stretch bands, pilates balls, etc. will also be used in the implementation of study training protocols. The main program of closed kinetic chain exercises includes exercises such as mini squats, front and side step-ups, front and side step-downs, wall sliding, heel rising, lunge exercises from the front and sides, quadriceps setting exercises, and single leg mini squats.</i_keyword>
      <i_keyword>Control group: Land-based-Closed Kinetic Chain exercises:                                       The exercises of both groups will be applied by an expert certified in the field of corrective exercises and sports rehabilitation. The exercises will also be approved by a physiotherapist specializing in exercise therapy. The exercises will be performed for eight weeks, three sessions a week, and 60 minutes each week. In each session, 10 minutes of warm-up exercises (forward walking, backward walking, lateral walking, and stretching movements), 10 minutes of cooling down exercises (stretching movements), and the main exercise protocol will last 40 minutes.  Tools such as chairs, steps, weights, stretch bands, pilates balls, etc. will also be used in the implementation of study training protocols. The main program of closed kinetic chain exercises includes exercises such as mini squats, front and side step-up, front and side step-downs, wall sliding, heel rising, lunge exercises from the front and sides, quadriceps setting exercises, and single leg mini squats.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"Assessment of pain intensity". Timepoint: Before and eight weeks after the intervention. Method of measurement: "VAS visual scale".</prim_outcome>
      <prim_outcome>Function. Timepoint: "Before and eight weeks after the intervention". Method of measurement: "UGT test, 40 meters walking test and going up and down 8 standard stairs".</prim_outcome>
      <prim_outcome>"Knee instability". Timepoint: "Before and eight weeks after the intervention". Method of measurement: "Felson Questionnaire".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Kinesiophobia. Timepoint: "Before and eight weeks after the intervention". Method of measurement: Tampa scale.</sec_outcome>
      <sec_outcome>Knee proprioception. Timepoint: "Before and eight weeks after the intervention". Method of measurement: "Inclinometer".</sec_outcome>
      <sec_outcome>"Quality of life (OAKHQoL)". Timepoint: "Before and eight weeks after the intervention". Method of measurement: "OAKHQoL questionnaire".</sec_outcome>
      <sec_outcome>"Distribution of plantar pressure". Timepoint: "Before and eight weeks after the intervention". Method of measurement: "PET-Scan machine".</sec_outcome>
      <sec_outcome>"Strength of the muscles acting on the knee". Timepoint: "Before and eight weeks after the intervention". Method of measurement: "Pull-Push dynamometer".</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>Red Crescent</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-16</approval_date>
        <contact_name>Vice President of Education, Research and Technology of the Red Crescent Society</contact_name>
        <contact_address>Block 20, Plot 416, Phase 2, Elkhebal St., Imam Reza Town, Kermanshah-Sahne city Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
