<?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>IRCT20210129050172N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-21</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Investigating the effect of exercise program on improving sleep quality and quality of life</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Exercise Program on Improving Quality of Life and Sleep Quality in the Elderly with Osteoarthritis of the Knee</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53988</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples are assigned to the study groups (intervention and control) by blocking randomization method with 4 blocks.Randomization tool: https://www.sealedenvelope.com/simple-randomiser/v1/lists.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoarthritis of knee.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, the Pittsburgh Sleep Quality Index (PSQI) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) are completed by the intervention group. The intervention group will undergo a training program for 4 weeks (one 30-minute session per week). 4 weeks later, exercise is done at home with the presence of the researcher. Then the mentioned questionnaires will be evaluated and compared in this group.Exercises will be presented in 4 sessions of 30 minutes. The first session includes 7 exercises to strengthen the quadriceps muscles (such as intermittent contraction and relaxation of this muscle, standing on one foot and bringing the heel of the other foot closer to the small serine muscle, mini-squat movement, bridge exercises, straight leg raising exercises and ...).The second session includes 3 leg muscle stretching exercises (such as gentle leg stretching, standing on the wall with one leg in the back and the other leg in the front stretching, etc.) and 2 hamstring muscle stretching exercises (hamstring muscle stretching and Improve the range of motion of the knee by lying down and bringing one foot closer to the chest with the hands or a strap).The third session includes 2 exercises to strengthen the large serine muscle to control the torso, leg stability and balance while standing and walking (including strengthening these muscles while lying on the abdomen and contracting the buttocks and then raising one leg, sitting on a chair and while The knee is bent, lifting it off the floor) and 3 exercises to strengthen the legs (such as strengthening the legs by. Intervention 2: Control group: No intervention is performed for the control group.</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 Contains confidential information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sara safarnia shahri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran province in front of Imam Khomeini shrine, Persian Gulf freeway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33191​18651</zip>
        <telephone>098 21 51213565</telephone>
        <email>publicrelation@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Persian Gulf Highway (Tehran - Qom), facing the holy shrine Imam Khomeini, Shahed University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 3565</telephone>
        <email>mheidari@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have the criteria of the American College of Rheumatology in terms of clinical and radiographic
Experiencing knee pain most days of the last month
Ability to walk independently and perform daily activities independently
Ability to answer the questionnaire's questions physically and mentally
Physical and mental ability to participate in sports exercises based on the diagnosis of the treating physician
Stability of blood pressure to participate in the study</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Symptoms of knee lock
Knee surgery and replacement in the last 6 months
Severe knee deformity
History of knee malignancy, wound and infection around the knee, history of knee fracture, knee hypermobility and instability
Existence of metabolic and endocrine disorders such as diabetes, thyroid disease
Having health problems affecting home exercise such as uncontrolled high blood pressure, heart disorder, brain disorder, shortness of breath, arrhythmia, severe vision problems.
Chronic use of a knee brace, cane, walker or wheelchair
Corticosteroid injection during the last 30 days
Injection of hyaluronic acid into the symptomatic joint within the last six months
Osteoporosis</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>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, the Pittsburgh Sleep Quality Index (PSQI) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) are completed by the intervention group. The intervention group will undergo a training program for 4 weeks (one 30-minute session per week). 4 weeks later, exercise is done at home with the presence of the researcher. Then the mentioned questionnaires will be evaluated and compared in this group.Exercises will be presented in 4 sessions of 30 minutes. The first session includes 7 exercises to strengthen the quadriceps muscles (such as intermittent contraction and relaxation of this muscle, standing on one foot and bringing the heel of the other foot closer to the small serine muscle, mini-squat movement, bridge exercises, straight leg raising exercises and ...).The second session includes 3 leg muscle stretching exercises (such as gentle leg stretching, standing on the wall with one leg in the back and the other leg in the front stretching, etc.) and 2 hamstring muscle stretching exercises (hamstring muscle stretching and Improve the range of motion of the knee by lying down and bringing one foot closer to the chest with the hands or a strap).The third session includes 2 exercises to strengthen the large serine muscle to control the torso, leg stability and balance while standing and walking (including strengthening these muscles while lying on the abdomen and contracting the buttocks and then raising one leg, sitting on a chair and while The knee is bent, lifting it off the floor) and 3 exercises to strengthen the legs (such as strengthening the legs by</i_keyword>
      <i_keyword>Control group: No intervention is performed for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life in KOOS and SF12 questionnaires. Timepoint: before the intervention and two months after the exercise program. Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS); 12-Item Short Form Health Survey (SF-12).</prim_outcome>
      <prim_outcome>Quality of sleep in Pittsburgh Sleep Quality Index  (PSQI). Timepoint: before the intervention and two months after the exercise program. Method of measurement: Pittsburgh Sleep Quality Index  (PSQI).</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-25</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Shahed university – Opposite Holy Shrine of Imam Khomeini- Khalij Fars Expressway – Tehran - Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
