<?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>IRCT20231120060118N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-19</date_registration>
      <primary_sponsor>University of Kashan</primary_sponsor>
      <public_title>Effect of Exercise on Static and Dynamic Stability of Patients with Knee Osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Eight Weeks Land-Based Exercise on Static and Dynamic Stability of Elderly Women with Knee Osteoarthritis During Walking</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74795</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: A simple randomization method was used for randomization. For this purpose, a number of sealed opaque envelopes were considered. In this method, mail envelopes with the name of one of the intervention and control groups were registered to the number of subjects, and after merging the envelopes, the subject chose an envelope and its allocation was recorded. In order to hide the random sequence, sealed and waxed opaque envelopes with random sequence were used. After creating a random sequence based on the sample size, a number of envelopes with non-transparent envelopes (in order to make the contents of the envelopes unclear) were prepared and each of the random sequences created was recorded on a card and the cards were placed inside the envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes was numbered in the same order. Finally, the lid of the letter envelopes was glued and placed in a box in order.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: A group of 12 people with knee osteoarthritis who do exercise training for 8 weeks and 3 sessions per week.The duration of the exercise is 45 to 60 minutes. Training includes muscle release which was done using foam roll and tennis ball.These exercises were performed in 1 to 3 sets and for a maximum of one minute in the hamstrings, quadriceps, gastrocnemius and soleus muscles, thigh adductors, iliotibial band, plantar fascia, pectoral, rhomboid, trapezius and trunk extensors. In the second stage, the lower muscles, which included the hamstrings, gastrocnemius and soleus, and iliotibial band, were stretched for 20 to 60 seconds for 1 to 4 sets Then, in the last stage, strength exercises were prescribed for the subjects according to their individual fitness. In this stage, isometric and isotonic exercises were performed in 1 to 3 sets. Isometric exercise 4 seconds up and rest 2 to 10 seconds and isotonic exercise 10 to 12 repetitions were performed. The strength exercises for these people included the contraction of the core muscles, modified lateral plank, hip abduction with external rotation,bridge with ball (isometric/isotonic), knee extension (isometric/isotonic), squat to the wall and seated calf raise.This training group of 12 people were tested at the beginning and at the end of 8 weeks. Intervention 2: A group of 12 people with knee osteoarthritis who do not do any Exercise activities for 8 weeks.A weekly report was prepared from these people and this report included the daily activities and lifestyle of these people during the week. This control group of 12 people were tested at the beginning and at the end of 8 weeks.</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>Piunik Hovsepian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahari Blvd</address>
        <city>Shahinshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8313755431</zip>
        <telephone>+98 31 4534 7264</telephone>
        <email>Piunik.hovsepian@grad.kashanu.ac.ir</email>
        <affiliation>University of Kashan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Keyvan Sharifmoradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qotb-e Ravandi Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8731753153</zip>
        <telephone>+98 913 915 0316</telephone>
        <email>ksharifmoradi@gmail.com</email>
        <affiliation>University of Kashan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals with knee osteoarthritis severity of grade 2 or 3 are determined based on the Kellgren-Lawrence scale through radiography.
Self-reported knee osteoarthritis has been officially documented, detailing symptoms such as pain in the past month and morning stiffness.</inclusion_criteria>
      <agemin>57 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Heart disease or uncontrolled blood pressure
Uncontrolled diabetes
Any neurological disease such as epilepsy, vertigo, stroke or Parkinson's disease
Joint injection in the last three months
Traumatic surgery of the lower limb
Any recent knee injury
Lower limb arthroplasty
Having arthritis of the hip and ankle joints, as well as other joint diseases other than knee osteoarthritis
Participating in any physiotherapy or hydrotherapy treatment in the past three months
Use of medical equipment to assist in walking such as a cane
Failure to complete training sessions by the subject</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>A group of 12 people with knee osteoarthritis who do exercise training for 8 weeks and 3 sessions per week.The duration of the exercise is 45 to 60 minutes. Training includes muscle release which was done using foam roll and tennis ball.These exercises were performed in 1 to 3 sets and for a maximum of one minute in the hamstrings, quadriceps, gastrocnemius and soleus muscles, thigh adductors, iliotibial band, plantar fascia, pectoral, rhomboid, trapezius and trunk extensors. In the second stage, the lower muscles, which included the hamstrings, gastrocnemius and soleus, and iliotibial band, were stretched for 20 to 60 seconds for 1 to 4 sets Then, in the last stage, strength exercises were prescribed for the subjects according to their individual fitness. In this stage, isometric and isotonic exercises were performed in 1 to 3 sets. Isometric exercise 4 seconds up and rest 2 to 10 seconds and isotonic exercise 10 to 12 repetitions were performed. The strength exercises for these people included the contraction of the core muscles, modified lateral plank, hip abduction with external rotation,bridge with ball (isometric/isotonic), knee extension (isometric/isotonic), squat to the wall and seated calf raise.This training group of 12 people were tested at the beginning and at the end of 8 weeks.</i_keyword>
      <i_keyword>A group of 12 people with knee osteoarthritis who do not do any Exercise activities for 8 weeks.A weekly report was prepared from these people and this report included the daily activities and lifestyle of these people during the week. This control group of 12 people were tested at the beginning and at the end of 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static balance. Timepoint: The pre-test, the eight-week training period and the post-test are taken at the end. Method of measurement: Kistler 9260 AA force plate was used to measure static balance.</prim_outcome>
      <prim_outcome>Gait balance. Timepoint: The pre-test, the eight-week training period and the post-test are taken at the end. Method of measurement: Qualisys Track Manager (QTM) movement analysis system (manufactured by QTM Company, USA) including 7 cameras was used to measure walking balance. The cameras and power plate were set to work simultaneously.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stride Length. Timepoint: Pre-test and post-test. Method of measurement: Qualisys Track Manager (QTM) motion analysis system (manufactured by QTM Company, USA) including 7 cameras was used to measure walking variables.</sec_outcome>
      <sec_outcome>Step Width. Timepoint: Pre-test and post-test. Method of measurement: Qualisys Track Manager (QTM) motion analysis system (manufactured by QTM Company, USA) including 7 cameras was used to measure walking variables.</sec_outcome>
      <sec_outcome>Step Length. Timepoint: Pre-test and post-test. Method of measurement: Qualisys Track Manager (QTM) motion analysis system (manufactured by QTM Company, USA) including 7 cameras was used to measure walking variables.</sec_outcome>
      <sec_outcome>Cadence. Timepoint: Pre-test and post-test. Method of measurement: Qualisys Track Manager (QTM) motion analysis system (manufactured by QTM Company, USA) including 7 cameras was used to measure walking variables.</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>University of Kashan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-31</approval_date>
        <contact_name>Ethics Committee in Kashan University Research</contact_name>
        <contact_address>Qotb-e Ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
