<?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>IRCT20140408017177N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-25</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of addition of lumbar support belt to core and knee exercises in recreational endurance runners with patellofemoral pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of addition of lumbar support belt to core and knee exercises on pain, performance and balance in recreational endurance runners with patellofemoral pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77019</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be randomly assigned to one of the two study groups using the block randomization method using the online randomisation sealedenvelope.com in 8 blocks of 4, Blinding description: In this study, the evaluator, and the person who analyzes the data will be unaware of which group each participant is in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellofemoral pain in in recreational endurance runners.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group, doing same control exercises in 10 sessions plus lumbar belt (everytime they run) for 4 weeks. Intervention 2: Control group:Exercises in both groups are performed for 4 weeks, in 10 sessions (once every 3 days), for about 19-25 minutes at home using checklists. These checklists are given to them to confirm the exercises and according to the exercise program,exercises will change on the 3rd and 6th sessions. 3 initial sessions (about 19 minutes) 1. Stretching of the hamstrings, iliotibial band and gastrocnemius muscles (hold for 30 seconds, repeat 5 times) 2. Sting of the quadriceps muscle (hold for 10 seconds, repeat 10 times) 3. Bridge while a ball is placed between the legs (3 repetitions, hold for 10 seconds) 4. Lying on the side and abduction of the hip joint (6 repetitions, holding for 10 seconds) 3 secondary sessions (about 21 minutes) 1. Straight leg lifting (3 sets) , 10 repetitions, hold for 10 seconds) 2. Step-up movement from the front (3 sets, 10 repetitions) 3. Raising the leg while lying on the side (3 sets, 10 repetitions) 4. Sitting down while a ball be between the legs (repeat 5 times, hold for 10 seconds).   The last 4 sessions (about 25 minutes) 1. Squatting at 30 degree knee flexion (3 sets, hold for 10 seconds) 2. Step-up from the side (3 sets, hold for 10 seconds) 3. Contraction of the hip abduction muscles in standing position Isometrically (15 repetitions, hold for 5 seconds) 4. Alternately move the shoulder forward and backward while standing on the involved limb (15 repetitions, hold for 5 seconds) 5. While standing on the involved leg, trunk to the healthy side rotate while the hip joint is in internal rotation (15 repetitions, hold for 5 seconds) 6. Sit down while a ball is between the legs and the knees are straight (6 repetitions, hold for 10 seconds) 7. Sit down from the side while that the ball is between the legs and the knee is flat (hold 6 times for 10 seconds).</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>Iman Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirul Mominin (AS) Burn Accident Hospital, Shahid Doran Campus, School of Rehabilitation Sciences, Sadra City Road, Shiraz, Fars, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7198754361</zip>
        <telephone>+98 71 3212 2600</telephone>
        <email>irezaei@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Iman Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirul Mominin (AS) Burn Accident Hospital, Shahid Doran Campus, School of Rehabilitation Sciences, Sadra City Road, Shiraz, Fars, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7198754361</zip>
        <telephone>+98 71 3212 2600</telephone>
        <email>irezaei@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of the runner between 18 and 40 years
Pain in the front of the knee when running and during at least three activities: going up and down stairs, running, squatting, kneeling and sitting for long periods of time.
At least three months of pain in the front of the knee
Pain intensity between 3 and 7 on the visual analog scale and a score of 50 to 80 on the Kojala questionnaire in the last month before the intervention
Running at least 3 days a week for at least 30 and at most 55 minutes a day
People with patellofemoral pain if their pain originates from behind the patella (i.e. pain behind the patella)
No use of painkillers, two weeks before the start of the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Knee, lower limb and trunk surgery
Structural disorders of the knee
Presence of pathology in knee meniscus, ligaments and tendons
A history of patellar dislocation or subluxation
The presence of muscle tears, Osgoodschlatter syndrome, Johanson syndrome and Plica syndrome
Systemic diseases such as diabetes, rheumatological disorders, etc
Cardiopulmonary diseases
Diseases of the visual system
Alcoholism and smoking
back pain
pregnancy
lumbar belt intolerance</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellofemoral disorders</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, doing same control exercises in 10 sessions plus lumbar belt (everytime they run) for 4 weeks.</i_keyword>
      <i_keyword>Control group:Exercises in both groups are performed for 4 weeks, in 10 sessions (once every 3 days), for about 19-25 minutes at home using checklists. These checklists are given to them to confirm the exercises and according to the exercise program,exercises will change on the 3rd and 6th sessions. 3 initial sessions (about 19 minutes) 1. Stretching of the hamstrings, iliotibial band and gastrocnemius muscles (hold for 30 seconds, repeat 5 times) 2. Sting of the quadriceps muscle (hold for 10 seconds, repeat 10 times) 3. Bridge while a ball is placed between the legs (3 repetitions, hold for 10 seconds) 4. Lying on the side and abduction of the hip joint (6 repetitions, holding for 10 seconds) 3 secondary sessions (about 21 minutes) 1. Straight leg lifting (3 sets) , 10 repetitions, hold for 10 seconds) 2. Step-up movement from the front (3 sets, 10 repetitions) 3. Raising the leg while lying on the side (3 sets, 10 repetitions) 4. Sitting down while a ball be between the legs (repeat 5 times, hold for 10 seconds).   The last 4 sessions (about 25 minutes) 1. Squatting at 30 degree knee flexion (3 sets, hold for 10 seconds) 2. Step-up from the side (3 sets, hold for 10 seconds) 3. Contraction of the hip abduction muscles in standing position Isometrically (15 repetitions, hold for 5 seconds) 4. Alternately move the shoulder forward and backward while standing on the involved limb (15 repetitions, hold for 5 seconds) 5. While standing on the involved leg, trunk to the healthy side rotate while the hip joint is in internal rotation (15 repetitions, hold for 5 seconds) 6. Sit down while a ball is between the legs and the knees are straight (6 repetitions, hold for 10 seconds) 7. Sit down from the side while that the ball is between the legs and the knee is flat (hold 6 times for 10 seconds).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: pre-intervention, post-intervention, 4 weeks post-intervention. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Performance level. Timepoint: pre-intervention, post-intervention, 4 weeks post-intervention. Method of measurement: Step down performance test and Kujala questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dynamic balance. Timepoint: Pre-intervention, Post-intervention, 4 weeks post-intervention. Method of measurement: Modified SEBT balance test.</sec_outcome>
      <sec_outcome>Speed. Timepoint: Pre-intervention, Post-intervention, 4 weeks post-intervention. Method of measurement: 50 meters test.</sec_outcome>
      <sec_outcome>Agility. Timepoint: Pre-intervention, Post-intervention, 4 weeks post-intervention. Method of measurement: T test.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-25</approval_date>
        <contact_name>Ethics Committee of Shiraz School of Rehabilitation Sciences</contact_name>
        <contact_address>Amirul Mominin (AS) Burn Accident Hospital, Shahid Doran Campus, School of Rehabilitation Sciences, Sadra City Road, Shiraz, Fars, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
