<?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>IRCT20240512061759N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-12</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Pilates and proprioceptive neuromuscular facilitation on pain and muscle power in knee joint wear</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Pilates exercises and Proprioceptive neuromuscular facilitation on pain and muscle power in patients with knee joint wear</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76835</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be selected as available sampling from among the patients suffering from wear and tear of the knee joint referring to the hospitals and Shahid Mofatteh Clinic in Yasuj city and will be based on random block allocation which according to the studied groups (three groups ) including intervention 1 (Pilates exercises), intervention 2 (proprioceptive neuromuscular facilitation exercises) and control based on the calculated factorial law, i.e. 3! A for intervention group 1 (Pilates exercises), B for intervention group 2 (proprioceptive neuromuscular facilitation exercises) and C for the control group will be compiled based on the table below.
6      5       4      3       2     1
CBA CAB BCA BAC ACB ABC

 Then, since the estimated sample size is 54 people, three samples are placed in each block, each representative of a study group and their arrangement order is also different, and from these blocks, sampling will be done by placement, Blinding description: The person who performs the statistical analysis does not know about the allocation of groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>knee joint wear.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group receives Pilates exercises twice a week for eight weeks. the duration of Pilates exercises, including warm-up and cool-down, is about 60 minutes. In the exercises, the principle of overload is observed and gradually the number of exercises and their repetitions are increased. Intervention 2: Intervention group: This group receives proprioceptive neuromuscular facilitation exercises twice a week for eight weeks. The duration of PNF exercises, including warm-up and cool-down, is about 60 minutes. In the exercises, the principle of overload is observed and gradually the number of repetitions of exercises and sets is increased. Intervention 3: Control group: They do not receive any sports for eight weeks and are only evaluated with questionnaires and tools at specified times.</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:
The data will be available only to researchers working in academic and scientific institutions.

When:
The data will be published in the summer of 1403.

To whom:
The data will be available only to researchers working in academic and scientific institutions.

Conditions:
The data will be available only to researchers working in academic and scientific institutions.

Where to obtain:
omidrezamazarei1376@gmail.com

How to obtain:
Requested data and documents will be sent to them as soon as possible and in less than a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Mazarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>6th alley, 22 Bahman South Street</address>
        <city>کازرون</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7317833656</zip>
        <telephone>+98 71 4223 4125</telephone>
        <email>omidrezamazarei1376@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Mazarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>6th alley, 22 Bahman South Street</address>
        <city>کازرون</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7317833656</zip>
        <telephone>+98 71 4223 4125</telephone>
        <email>omidrezamazarei1376@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering from wear and tear in one or both knees based on radiographic evidence and the confirmation of an orthopedic doctor
Age range between 20 and 65 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Knee joint replacement
Corticosteroid injection into the desired knee joint during three months before the intervention
The presence of an open wound
Doing exercise and physical therapy regularly for two months before the intervention
Suffering from severe chronic diseases such as lupus, inflammatory arthritis, neurological diseases
The presence of diseases that damage the joint such as: osteonecrosis, osteoporosis, rheumatoid arthritis, neuromuscular disease, any symptoms of collagen and vascular disease, arthritis caused by gout and pseudo gout.
Not having acceptable cognitive ability
The existence of cryptography and dryness in the morning for less than 30 minutes
Use of oral corticosteroids one month before the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group receives Pilates exercises twice a week for eight weeks. the duration of Pilates exercises, including warm-up and cool-down, is about 60 minutes. In the exercises, the principle of overload is observed and gradually the number of exercises and their repetitions are increased.</i_keyword>
      <i_keyword>Intervention group: This group receives proprioceptive neuromuscular facilitation exercises twice a week for eight weeks. The duration of PNF exercises, including warm-up and cool-down, is about 60 minutes. In the exercises, the principle of overload is observed and gradually the number of repetitions of exercises and sets is increased.</i_keyword>
      <i_keyword>Control group: They do not receive any sports for eight weeks and are only evaluated with questionnaires and tools at specified times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in VAS test. Timepoint: The time to measure pain is in three stages, respectively: before the start of the intervention, in the middle of the intervention or four weeks after the start of the intervention and after the end of the intervention. Method of measurement: VAS test to measure pain. Questionnaire of consequences of osteoarthritis and knee injuries (KOOS).</prim_outcome>
      <prim_outcome>Muscle power score in MMT test. Timepoint: The time to muscle power is in three stages, respectively: before the start of the intervention, in the middle of the intervention or four weeks after the start of the intervention and after the end of the intervention. Method of measurement: MMT test to measure muscle power . Questionnaire of consequences of osteoarthritis and knee injuries (KOOS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Symptoms related to the disease. Daily life activities. Sports and recreational activities. Quality of life related to knee problems. Timepoint: Before starting the study. Four weeks after the start of the intervention. After the end of the intervention. Method of measurement: Questionnaire for the outcome of knee injuries and osteoarthritis, abbreviated as KOOS.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-14</approval_date>
        <contact_name>Ethics Committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Shahid Motahari Blvd, Yasuj, Kohgiluyeh and Boyer-Ahmad Province Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
