<?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>IRCT20170501033743N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-31</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of physical activity on postpartum health</public_title>
      <acronym></acronym>
      <scientific_title>Effect of eight weeks of combined exercises (High intensity interval training and Yuga) on the serum Estradiol and sexual function in postpartum</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25950</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, simple randomization method was used. This method makes the type of intervention assigned to each group completely unpredictable. Therefore, 20 healthy eligible women were divided into control and intervention groups. Random allocation software was used to generate random sequences. In this method, the computer randomly generated the letters A and B. The recipients of letter A joined the intervention group and letter B joined the control group and the allocation ratio of individuals in each group was equal. According to the names of the participants in the study, after obtaining a random letter by the computer, each letter was assigned to the list of participants in the study and the presence of individuals in the groups was determined. For example, the first letter obtained was given to the first person on the list, and this allocation was applied to the whole list.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Effect of physical activities  on Estradiol serum and sexual function. Condition 2: Assessment of  sexual function in postpartum.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Each session included 5 to 10 minutes of general warm-up program including stretching exercises and then 15-20 minutes of yoga exercises to strengthen and stretch muscles and body systems, especially the lower limbs and pelvis; as well as several jumping movements. And the explosion was performed optimally for a 2-5 minute increase in heart rate for running (HIIT) training and in the final stage a cooling program was performed for 5-10 minutes with yoga relaxation training.The HIIT exercise was performed so that the subjects ran at a maximum speed of 20 m from the starting point (cone number 1) to cone number two (path A), then turned in the opposite direction, They ran 20 m to cone No. 3 (track B). Finally, return again and run to the starting point (cone number 1) at maximum speed (route C) to complete the 40m distance. Subjects continued this process at maximum speed until the 30-second exercise period was completed. After 30 seconds of rest, the exercise was repeated. Exercise progression was increased by increasing the number of 30-second repetitions from 4 times in the first and second weeks, to 5 times in the third and fourth weeks, and 6 times in the fifth and sixth weeks, and 7 times in the seventh and eighth weeks. Intervention 2: Control group: During the 8 weeks of training protocol, the subjects in the control group did not have any regular exercise.</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 incomplete</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahereh Shokrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah st, Islamic Azad University of Bojnourd, Sport science department</address>
        <city>بجنورد</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9417697796</zip>
        <telephone>+98 58 3229 6985</telephone>
        <email>nshojaeian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najmeh-Alsadat Shojaeian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah St, Islamic Azad University of Bojnourd - Department of Sport Sciences</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9417697796</zip>
        <telephone>+98 58 3229 6985</telephone>
        <email>nshojaeian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being primiparous or second-born
Being in lactation (three to four months after childbirth)
To have a healthy baby
No complications of depression
To have a spouse
There were also no complications of preterm labor, high blood hypertension in pregnancy, history of liver, kidney, heart, diabetes, inflammatory disease, thrombotic or cerebrovascular diseases, mental illness, hyperlipidemia, atherometriosis, history of chemotherapy, or radiation therapy
For the past six months, no hormone replacement therapy, no use of vitamin E, no psychotropic drugs and other effective herbal or chemical drugs
No smoking and alcohol or drugs
Normal pre-pregnancy BMI</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>37 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>To have any illness that prevented them from engaging in physical activity
To loos the intervention more than three sessions
To do the regular exercise in postpartum
To gain a score higher  than 26.5 based on the sexual function questionnaire.
To have any emotional stress such as the death of relatives
To decide not to continue in research and/or withdrew her consent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Each session included 5 to 10 minutes of general warm-up program including stretching exercises and then 15-20 minutes of yoga exercises to strengthen and stretch muscles and body systems, especially the lower limbs and pelvis; as well as several jumping movements. And the explosion was performed optimally for a 2-5 minute increase in heart rate for running (HIIT) training and in the final stage a cooling program was performed for 5-10 minutes with yoga relaxation training.The HIIT exercise was performed so that the subjects ran at a maximum speed of 20 m from the starting point (cone number 1) to cone number two (path A), then turned in the opposite direction, They ran 20 m to cone No. 3 (track B). Finally, return again and run to the starting point (cone number 1) at maximum speed (route C) to complete the 40m distance. Subjects continued this process at maximum speed until the 30-second exercise period was completed. After 30 seconds of rest, the exercise was repeated. Exercise progression was increased by increasing the number of 30-second repetitions from 4 times in the first and second weeks, to 5 times in the third and fourth weeks, and 6 times in the fifth and sixth weeks, and 7 times in the seventh and eighth weeks</i_keyword>
      <i_keyword>Control group: During the 8 weeks of training protocol, the subjects in the control group did not have any regular exercise.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The main variable of the study was determination of serum estradiol level. Blood samples from the third to fifth days of menstruation were collected after two months of exercise for the experimental group and the control group by a lab expert through a vein of left hand (05 ml) in a sitting position and they were tested by ELISA method. Timepoint: After two months of exercise and between third to fifth days of menstruation. Method of measurement: Blood samples from the vein of left hand.</prim_outcome>
      <prim_outcome>Before and after two months of intervention, Sexual Function and Sexual Schema Questionnaire(FSFI) was used. This questionnaire measures women's sexual function in six areas including desire, mental stimulation, humidity, orgasm, satisfaction, sexual pain. The questionnaire was developed by Rosen et al. (2000). The FSFI Women's Sexual Function Index in Iran was standardized by Mohammadi and its consistency was obtained by using Cronbach's alpha coefficient (r = 0.85) as well as cutoff point for whole scale and subscales. Timepoint: Before and after the intervention was measured by a questionnaire. Method of measurement: Sexual Function and Sexual Schema 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>Islamic Azad University of Bojnourd</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-03</approval_date>
        <contact_name>Ethics committee of Islamic Azad university of Bojnourd</contact_name>
        <contact_address>Daneshgah BLV, Islamic Azad university of Bojnourd Bojnourd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
