<?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>IRCT20220626055280N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-13</date_registration>
      <primary_sponsor>Rashid Latif Medical College</primary_sponsor>
      <public_title>Effect of Aerobic and Kegel exercises on primary dysmenorrhea</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of Aerobic and Kegel exercises on menstruation related pain and fatigue in females with primary dysmenorrhea</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67603</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were allocated into two groups i.e.; Group A and Group B, by lottery method. Lottery method is a type of simple random sampling. In this method, each participant of the trial is assigned a unique number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. 45 cards were used. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them and are placed into two sets randomly. Total of 38 cards were taken out, 19 participants in each group, Blinding description: The blinding of patients means that the patients did not know which treatment group are they allocated. This blinding is achieved by concealment. The allocation sequence is concealed in envelopes which were numbered serially, and letter envelopes are opened only after all pre-intervention assessments of the participants have been completed.  This is done to avoid biasness.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patient of group A aerobic exercises: The protocols for exercise training in the study include,   Frequency: 3 days per week for one menstrual cycle. Time: 20-30 minutes per session (5-10minutes warm-up, 15-20 minutes aerobics, 5 minutes cool-down)Type: Stationary cycling and treadmill Speed: 4-6 mph. Intervention 2: Intervention group: Patient of group B received Kegel exercises in form of pelvic floor exercises [ 10 min] , and warm up and cool down [both for 5 min].Pelvic Tilt Patient is in crook lying position.  Ask them to lift the pelvis off the plinth with hands placed by the side. Hold this position for 10 seconds Repeat for 25 times. Kegel Exercise: Squeeze  the  pelvic muscle  for  10  seconds  and  relax it  for  10  seconds  stop after  3 repetitions.  Repeat this exercise three times in a day. Flutter Exercise: Squeeze the pelvic  muscles and relax it as quickly as possible for 10 contractions. It is recommended 3times a day. Subtle Exercise: First exercise, except that with the imagination that the person is sucking and holding tampon in the vagina for 10 seconds and release the contraction. Relax 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>Maryam Sarfraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-Km Ferozepur road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 333 4435278</telephone>
        <email>maryamsarfraz33@gmail.com</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazeer Ahmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-Km Ferozepur road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 333 8054247</telephone>
        <email>nazeer.ahmad@rlmc.edu.pk</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18-25 years old, young female
Menustral Bleeding time 3-10 days
Previously diagnosed with primary dysmenorrhea
Not practicing physical exercise for more than 3 times a week ,for more than 30 min</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>taking any vitamin or mineral supplementation during menstrual cycle
history of irregular cycles
history of gynecological surgery
women who use oral contraceptives
chronic disease e.g.: heart disease ,respiratory  disease ,asthma, nervous disorder</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patient of group A aerobic exercises: The protocols for exercise training in the study include,   Frequency: 3 days per week for one menstrual cycle. Time: 20-30 minutes per session (5-10minutes warm-up, 15-20 minutes aerobics, 5 minutes cool-down)Type: Stationary cycling and treadmill Speed: 4-6 mph</i_keyword>
      <i_keyword>Intervention group: Patient of group B received Kegel exercises in form of pelvic floor exercises [ 10 min] , and warm up and cool down [both for 5 min].Pelvic Tilt Patient is in crook lying position.  Ask them to lift the pelvis off the plinth with hands placed by the side. Hold this position for 10 seconds Repeat for 25 times. Kegel Exercise: Squeeze  the  pelvic muscle  for  10  seconds  and  relax it  for  10  seconds  stop after  3 repetitions.  Repeat this exercise three times in a day. Flutter Exercise: Squeeze the pelvic  muscles and relax it as quickly as possible for 10 contractions. It is recommended 3times a day. Subtle Exercise: First exercise, except that with the imagination that the person is sucking and holding tampon in the vagina for 10 seconds and release the contraction. Relax for 10 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pre and 1 Month Post. Method of measurement: The intensity of pain is measured by the numeric pain rating scale which is an accurate and reliable tool for measuring pain intensity symptoms of primary dysmenorrhea.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: Pre and 1 Month Post. Method of measurement: Fatigue is assessed by an accurate and reliable fatigue severity scale.</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>Rashid Latif Medical College</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-05</approval_date>
        <contact_name>Institutional Review Board of Rashid Latif Medical College</contact_name>
        <contact_address>35-Km Ferozepur road Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
