<?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>IRCT20230216057434N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-05</date_registration>
      <primary_sponsor>Self funded</primary_sponsor>
      <public_title>Pilates exercises in Primary Dysmenorrhea</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Effects of Pilates exercises versus Aerobic Training on Menstrual Pain, Balance  and Daily Functioning in University Students with Primary Dysmenorrhea</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>57</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68934</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through a computer software "Random allocation software Version 2. The total sample size will be entered with required number of participants to be allocated in two groups. An automated randomization list will be achieved with attrition rate included.
The program starts running with the default settings. Users may run the program with the default settings or set the number of groups, the name of participants in each group and the sample size. Clicking the 'Generate' button produces the random sequence. Before generating the random sequence, the option window will be displayed and different randomization settings can be entered, Blinding description: Blinding will be done on part of outcome assessor who will be an experienced therapist. Patients will be assessed by him at the end of treatment session. He will be blinded about the type of intervention patient will received.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary Dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 ( Pilates exercises): The training will be started with warm-up exercises including simple stretching of whole body for 10 minutes preceded by Pilates for 20 minutes, and followed by cool-down exercises comprising of simple breathing for 10 minutes.The session will be conducted three times per week, each session will be started with warm up exercise including simple stretching for 10 minutes preceded by pilates for 20 minutes, and followed by cool down exercises comprising of simple breathing for 10 minutes.Pilates exercises will be performed at basic level in the form of roll up(6 repetition), double leg stretch(5-10 repetition) and spine stretch foreward(5 repetition) for first two weeks, intermediate level with the single leg stretch(10 repetitions), saw(4 repitition) and criss cross(5-10 repetitions) for third to fifth week and advance level in the form of shoulder bridge(3 repetitions) for sixth to eighth week. Intervention 2: Intervention group 2 (Aerobic Training)The training will be started with warm-up exercises including simple stretching of whole body for 10 minutes preceded by Aerobic training for 20 minutes, and followed by cool-down exercises comprising of simple breathing for 10 minutes. The aerobic training session will be conducted three times per week each session will be started with warm up exercise including simple stretching for 10 minutes preceded by running on treadmill (B1 motorized treadmill 3.0 HP, black) for 20 minutes, and followed by cool down exercises comprising of simple breathing for 10 minutes .During the session the distance covered by the participants on the treadmill and the heart rate will be recorded via pedometer and radial pulse with  70-85% of their  maximum heart rate (maximum heart rate= 206-88% of age in years) respectively.</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 Real Patient involved</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zainab Sheraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 335 6600141</telephone>
        <email>zainab.48@hotmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zainab Sheraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 335 6600141</telephone>
        <email>zainab.48@hotmail.com</email>
        <affiliation>Riphah International University, Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Students with Primary Dysmenorrhea
Age group 18 to 25 years
Having regular Menstrual cycles
Moderate-to-severe Primary Dysmenorrhea-associated pain, indicated by a score of ≥4 on a numerical rating scale
Ranging from ‘0’ (no pain) to ‘10’ (unbearable pain) for at least two previous consecutive menstrual periods</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Menstrual cycles &gt; 35 days apart•
Pregnant females
No pain relief with over the counter analgesics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary dysmenorrhea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 ( Pilates exercises): The training will be started with warm-up exercises including simple stretching of whole body for 10 minutes preceded by Pilates for 20 minutes, and followed by cool-down exercises comprising of simple breathing for 10 minutes.The session will be conducted three times per week, each session will be started with warm up exercise including simple stretching for 10 minutes preceded by pilates for 20 minutes, and followed by cool down exercises comprising of simple breathing for 10 minutes.Pilates exercises will be performed at basic level in the form of roll up(6 repetition), double leg stretch(5-10 repetition) and spine stretch foreward(5 repetition) for first two weeks, intermediate level with the single leg stretch(10 repetitions), saw(4 repitition) and criss cross(5-10 repetitions) for third to fifth week and advance level in the form of shoulder bridge(3 repetitions) for sixth to eighth week.</i_keyword>
      <i_keyword>Intervention group 2 (Aerobic Training)The training will be started with warm-up exercises including simple stretching of whole body for 10 minutes preceded by Aerobic training for 20 minutes, and followed by cool-down exercises comprising of simple breathing for 10 minutes. The aerobic training session will be conducted three times per week each session will be started with warm up exercise including simple stretching for 10 minutes preceded by running on treadmill (B1 motorized treadmill 3.0 HP, black) for 20 minutes, and followed by cool down exercises comprising of simple breathing for 10 minutes .During the session the distance covered by the participants on the treadmill and the heart rate will be recorded via pedometer and radial pulse with  70-85% of their  maximum heart rate (maximum heart rate= 206-88% of age in years) respectively</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Assessment will be performed at 0 week (baseline) at 4t week and at completion of 8 weeks treatment. Method of measurement: McGill pain Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Static Balance. Timepoint: Assessment will be performed at 0 week (baseline) at 4th week and at completion of 8 weeks treatment. Method of measurement: one leg standing test with eyes open and closed.</sec_outcome>
      <sec_outcome>Dynamic balance. Timepoint: Assessment will be performed at 0 week (baseline) at 4th week and at completion of 8 weeks treatment. Method of measurement: Berge Balance Scale.</sec_outcome>
      <sec_outcome>Daily Functioning. Timepoint: Assessment will be performed at 0 week (baseline) at 4th week and at completion of 8 weeks treatment. Method of measurement: Brief Pain Inventory - Short form.</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>N/A</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-12</approval_date>
        <contact_name>Ethics committee of Riphah International University Faisalabad</contact_name>
        <contact_address>Riphah International University, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
