<?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>IRCT20230928059543N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-25</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise on the movement status of patients after knee joint replacement</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Impact of Home-Based Exercise Training and Clinic-Based Physiotherapy on the Mobility Status of Patients Following Knee Joint Replacement Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77935</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of participants by permutation blocks in 10 blocks of 8 and using Random Allocation Software (RAS) version 4/9 (Internet address: https://random-allocation-software.software.informer.com) /2.0/) will be assigned to two groups of home-based exercise or clinic-based physical therapy.
Researchers will use the block randomization method for random allocation, the unit of randomization will be the individual (we do not have stratified randomization), and the tool will be the RAS version 4.9 software.
There is no blinding in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group receiving home-based exercise training. These exercises include: home-based exercise intervention: from the second day after the knee joint replacement surgery, the home-based exercise group will undergo home-based exercise twice a day for a period of 1 month. The physiotherapist will teach the patient and his companion how to perform physical exercises in a face-to-face meeting at the patient's home. At the same time as the training, it will be filmed by the patient's companion, so that the patient and his companion can see it at home and while doing sports), also during this period of 1 month, the physiotherapist through a phone call on the exercises Patient-centered exercise monitors. Full knee extension exercise • The patient sits on a bed or a flat surface. • It straightens the operated leg as completely as possible. • A folded or rolled towel is placed under the heel of the patient's foot. Another person stands next to the patient and the operated leg, he puts one of his hands on the patient's thigh 10-15 cm above the knee and the other on the patient's leg 10-15 cm below the knee. It applies to the patient's operated knee. Of course, in case of applying pressure and feeling pain in the patient's leg, it is sufficient to apply pressure to the extent that the patient feels the pain. He applies pressure for 5 seconds and releases it. Performs range of motion exercises • The patient is placed on the edge of the bed. The height of the bed should be such that the patient's leg remains hanging. The patient places the healthy (non-operated) leg on the operated leg and straightens and raises the leg as much as possible and keeps this position for 5 seconds. and leaves • Then in the same position (healthy leg on the operated leg) he bends the operated leg as much as possible and in this he takes help from the healthy leg to apply pressure to reach the maximum amount of bending. This exercise also requires 5 seconds of maintaining the position. • The patient performs this exercise twenty to thirty times twice a day (28). Exercise to strengthen the quadriceps muscle • This exercise is divided into two parts of three weeks • The first three weeks: the patient sits on a chair, raises the operated leg in a position that is straightened as much as possible and is in line with the chair He stays in this position for 10 seconds and then lowers his leg. The patient repeats this exercise thirty times twice a day. Second three weeks: This time the exercise becomes a little more difficult. The patient places the non-operated leg on the operated leg and while we see the greatest level of straightening in the leg, he raises the operated leg up to the level of the chair. This exercise should also be done thirty times twice a day. Intervention 2: Control group: This group receives clinic-based physiotherapy.</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 There is more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Armin Fereidouni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz,  Namazi Hospital, Fatemeh Faculty of Nursing and Midwifery (S), postal code: 13119-71936</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7167755954</zip>
        <telephone>+98 71 3753 2383</telephone>
        <email>arminfereidoni@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Armin fereidouni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7167755954</zip>
        <telephone>+98 71 3753 2383</telephone>
        <email>arminfereidoni@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Age range from 40 to 90 years
Literate to read and write</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to complete the questionnaire
Failure to complete physical therapy sessions or exercise according to self-report
Bleeding and infection after surgery
Abnormal pain and joint and prosthesis malfunction
Patients not going to the doctor after the interventions
Failure to do exercises at home by people who have received clinic-based physiotherapy.
The presence of severe deformities or a history of surgery in the lower limbs and spine
Suffering from specific psychological diseases according to self-report according to MMSE mental state questionnaire
Presence of internal diseases (such as gout), diseases of the nervous and central system (such as stroke and MS)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T84.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified complication of internal orthopedic prosthetic device, implant and graft</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: The group receiving home-based exercise training. These exercises include: home-based exercise intervention: from the second day after the knee joint replacement surgery, the home-based exercise group will undergo home-based exercise twice a day for a period of 1 month. The physiotherapist will teach the patient and his companion how to perform physical exercises in a face-to-face meeting at the patient's home. At the same time as the training, it will be filmed by the patient's companion, so that the patient and his companion can see it at home and while doing sports), also during this period of 1 month, the physiotherapist through a phone call on the exercises Patient-centered exercise monitors. Full knee extension exercise • The patient sits on a bed or a flat surface. • It straightens the operated leg as completely as possible. • A folded or rolled towel is placed under the heel of the patient's foot. Another person stands next to the patient and the operated leg, he puts one of his hands on the patient's thigh 10-15 cm above the knee and the other on the patient's leg 10-15 cm below the knee. It applies to the patient's operated knee. Of course, in case of applying pressure and feeling pain in the patient's leg, it is sufficient to apply pressure to the extent that the patient feels the pain. He applies pressure for 5 seconds and releases it. Performs range of motion exercises • The patient is placed on the edge of the bed. The height of the bed should be such that the patient's leg remains hanging. The patient places the healthy (non-operated) leg on the operated leg and straightens and raises the leg as much as possible and keeps this position for 5 seconds. and leaves • Then in the same position (healthy leg on the operated leg) he bends the operated leg as much as possible and in this he takes help from the healthy leg to apply pressure to reach the maximum amount of bending. This exercise also requires 5 seconds of maintaining the position. • The patient performs this exercise twenty to thirty times twice a day (28). Exercise to strengthen the quadriceps muscle • This exercise is divided into two parts of three weeks • The first three weeks: the patient sits on a chair, raises the operated leg in a position that is straightened as much as possible and is in line with the chair He stays in this position for 10 seconds and then lowers his leg. The patient repeats this exercise thirty times twice a day. Second three weeks: This time the exercise becomes a little more difficult. The patient places the non-operated leg on the operated leg and while we see the greatest level of straightening in the leg, he raises the operated leg up to the level of the chair. This exercise should also be done thirty times twice a day</i_keyword>
      <i_keyword>Control group: This group receives clinic-based physiotherapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Movement status. Timepoint: The patient's movement status will be completed by the patients and with the help of the surgeon through the Lysholm questionnaire in the stage before the surgery and 2 months after the surgery. Method of measurement: Lyshulm questionnaire.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-01</approval_date>
        <contact_name>Ethics Committee of kashan University of Medical Sciences</contact_name>
        <contact_address>5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
