<?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>IRCT20190908044722N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-26</date_registration>
      <primary_sponsor>Urmia University</primary_sponsor>
      <public_title>Effects of Eight weeks Aquatic Training on Knee Proprioception and Gait Speed among Female Older Adults with Knee Osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Eight weeks Aquatic Therapy on Knee Proprioception and Gait Speed among Female Older Adults with Knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80111</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants were randomly allocated to either the aquatic therapy exercise group or the control group using a simple randomization method. The unit of randomization was the individual participant. The randomization was carried out using Random Allocation Software version 1.0.0. To ensure proper allocation concealment, a single individual, blinded to the group allocation, handled the enrollment and group assignment process. This individual generated the random sequence using the software and assigned participants to groups without revealing the allocation to either the participants or the researchers conducting the intervention. This procedure maintained the integrity of the randomization process, Blinding description: This study will be blinded, so the evaluators will not know which patients are in the intervention group and which are in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Aquatic Therapy :Participants in the aquatic therapy group will  complete an 8-week program, consisting of 2 sessions per week, held at Ardabil's Jam swimming pool. Each session will  last 60 minutes, including a 10-minute warm-up, 45 minutes of water exercises like : Heel Raises: ,Mini Squats, Hip Abduction ,Hip Extension ,Hip Flexion Step-Ups Arm Movements: , and a 5-minute cool-down. Intervention 2: Control group: The control group will not receive any active intervention but continued with their usual care.</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 Ethical Considerations: The ethical review board overseeing this study recommended against the release of IPD due to concerns about potential misuse or misinterpretation of the data outside of its intended context.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razieh Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756151818</zip>
        <telephone>43-32752741-044</telephone>
        <email>r.khanmohamadi65@yahoo.com</email>
        <affiliation>Urmia University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756151818</zip>
        <telephone>43-32752741-044</telephone>
        <email>r.khanmohamadi65@yahoo.com</email>
        <affiliation>Urmia University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Women aged 63 to  70 years
•	Diagnosed with KOA by a certified rheumatologist through both clinical assessment and X-ray examination
•	Inactive individuals, engaging in less than one hour of physical activity per week
•	Free from severe medical conditions such as diabetes, asthma, cardiovascular diseases, neurological conditions (e.g., seizures, brain surgeries, or chronic headaches), and skin diseases
•	Body mass index (BMI) below 40 kg/m²
•	Not participating in any other clinical study at the time of recruitment</inclusion_criteria>
      <agemin>63 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>•	History of knee surgeries or other joint diseases
•	Cortisone injection in the knee joint within the past month
•	Severe respiratory, neurological, or musculoskeletal disorders, or left ventricular dysfunction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M15.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary generalized (osteo)arthritis</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: Aquatic Therapy :Participants in the aquatic therapy group will  complete an 8-week program, consisting of 2 sessions per week, held at Ardabil's Jam swimming pool. Each session will  last 60 minutes, including a 10-minute warm-up, 45 minutes of water exercises like : Heel Raises: ,Mini Squats, Hip Abduction ,Hip Extension ,Hip Flexion Step-Ups Arm Movements: , and a 5-minute cool-down</i_keyword>
      <i_keyword>Control group: The control group will not receive any active intervention but continued with their usual care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee proprioception. Timepoint: before and after intervention. Method of measurement: In order to evaluate and test the sense of the knee joint position, a digital goniometer with an accuracy of 0.1 degrees will be used.</prim_outcome>
      <prim_outcome>Gait Speed. Timepoint: before and after intervention. Method of measurement: using the 10-Meter Walk Test.</prim_outcome>
      <prim_outcome>Cognitive Task Condition. Timepoint: before and after intervention. Method of measurement: Participants will be asked to perform a dual-task, walking the 10-meter distance while simultaneously engaging in a visuospatial N-back task.</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>Urmia University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-06</approval_date>
        <contact_name>Ethics committee of Urmia University</contact_name>
        <contact_address>Urmia University, Kilometer 11 of Cypress Road - West Azarbaijan Province -Urmia Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
