<?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>IRCT20241027063512N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-24</date_registration>
      <primary_sponsor>Razi University of Kermanshah</primary_sponsor>
      <public_title>Studying the effects of Nordic Walking and Simple Walking on the quality of life of Women With Knee Osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Studying the Effects of Nordic Walking on Balance, Cognitive Function and Disabilities Related to Knee Osteoarthritis in Elderly Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80201</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The output of the Generator Random Allocation software will be performed by a person not involved in the research, and the subjects will be randomly assigned to one of the experimental or control groups, Blinding description: The evaluator will not have any Knowledge of the type of intervention assigned to the groups during the pre-test evaluation phase.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: This group, which consists of 15 participants, walks with the help of adjustable Nordic walking poles. The duration of our intervention is six weeks, three sessions per week, each session lasting 60 minutes, which takes place outdoors. Each training session includes 15 minutes of warm-up, 35 minutes of walking, and 10 minutes of cool-down. Intervention 2: Second intervention group: In this group, which consists of 15 subjects, regular walking (without any equipment) is done outdoors for six weeks, three sessions per week, for 60 minutes. Of this time, 15 minutes are dedicated to warming up, 35 minutes to walking, and 10 minutes to returning to the starting position. Intervention 3: Control group: They do not receive any intervention. After the intervention is completed, healthy lifestyle education is provided.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information about the study outcomes will be shared.

When:
Access period starts 6 months after results are published.

To whom:
Sports science researchers and researchers at academic institutions

Conditions:
Research in the relevant field of work

Where to obtain:
Susan Panjalizad, sosanpanjali@gmail.com

How to obtain:
Sending a request from the requester, reviewing that request from the researcher, and responding immediately

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sosan Panjalizad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 6, Apadana Complex, Shahid Loghmani Alley, Shahid Fahmideh Shomali Blvd., Farhangian Phase 1</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714747863</zip>
        <telephone>+98 83 3822 2539</telephone>
        <email>sosanpanjali@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sosan Panjalizad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 6, Apadana Complex, Shahid Loghmani Alley, North Shahid Fahmideh Blvd., Farhangian Phase 1</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714747863</zip>
        <telephone>+98 83 3822 2539</telephone>
        <email>sosanpanjali@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 45 to 65 years
Chronic Knee pain on most days, for at least 3 months, pain score of at least4 on a Visual analog pain scale
No intra-articular injections in the past 3 months
Having the American College of Rheumatology clinical criteria for Knee Osteoarthritis</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Uncontrolled diabetes
Body mass index greater than or equal(BMI&gt;40kg&gt;m2), patients With severe obesity
Lower limb arthroplasty
Intra-articular steroid injections (within the past 6 months)
Systemic arthritis
Neuromuscular disorders that interfere with daily functioning, such as (stroke, uncontrolled muscle stiffness, tumor, etc.) Patients who are unable to walk without assistive devices
Patients who have undergone other exercise or nutritional treatments in the past three months
Neuromuscular diseases (such as MS and Parkinson's) that interfere with exercise programs
Fractures and surgery in the lower extremities
Use of any other type of therapeutic intervention during the period in which the subjects are in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M23.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other internal derangements of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: This group, which consists of 15 participants, walks with the help of adjustable Nordic walking poles. The duration of our intervention is six weeks, three sessions per week, each session lasting 60 minutes, which takes place outdoors. Each training session includes 15 minutes of warm-up, 35 minutes of walking, and 10 minutes of cool-down.</i_keyword>
      <i_keyword>Second intervention group: In this group, which consists of 15 subjects, regular walking (without any equipment) is done outdoors for six weeks, three sessions per week, for 60 minutes. Of this time, 15 minutes are dedicated to warming up, 35 minutes to walking, and 10 minutes to returning to the starting position.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention. After the intervention is completed, healthy lifestyle education is provided.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Assessing pain intensity. Timepoint: Measuring pain intensity before and after the test. Method of measurement: Measuring pain intensity with the McGill Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance assessment. Timepoint: Measurement before the intervention and after the intervention. Method of measurement: Technobody device,Pro-kin252N.</sec_outcome>
      <sec_outcome>Muscle strength assessment. Timepoint: Measurement before the intervention and after the intervention. Method of measurement: pull-push dynomometer.</sec_outcome>
      <sec_outcome>Proprioception of the knee joint assessment. Timepoint: Measurement before the intervention and after the intervention. Method of measurement: Inclinometer device.</sec_outcome>
      <sec_outcome>Motor function assessment. Timepoint: Measurement before the intervention and after the intervention. Method of measurement: Osteoarthritis Index Questionnaire, Up&amp;Go Test, 40 Merer Walking Time.</sec_outcome>
      <sec_outcome>Cognitive function assessment. Timepoint: Measurement before the intervention and after the intervention. Method of measurement: Montreal Cognitive Assessment questionnaire.</sec_outcome>
      <sec_outcome>Checking the level of quality of life. Timepoint: Measurement before the intervention and after the intervention. Method of measurement: Medical Outcomes Study Short Form Scale (SF-36).</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>Razi University of Kermanshah</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-23</approval_date>
        <contact_name>Research Ethics Committee, Razi University of Kermanshah</contact_name>
        <contact_address>Unit 6, Apadana Complex, Shahid Loghmani Alley, North Shahid Fahmideh Blvd., Farhangian Phase 1 Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
