<?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>IRCT20190410043222N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-02</date_registration>
      <primary_sponsor>Tarbiat  Modares University</primary_sponsor>
      <public_title>The effect of combined exercises in pregnancy and  TNF-α  levels and  Mean Arterial Pressure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a period of combined exercise training in overweight pregnant  women on inflammatory  factor ( TNF-α )  and  Mean Arterial Pressure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38729</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: Participating mothers are randomly assigned into two groups (intervention and control) based on entry number in the study and using the random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Pregnancy. Condition 2: overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group, after training exercise , begin  a Specific combined exercise schedule including aerobic, resistance and endurance activities from the 16 weeks of gestational age.The combination of exercises will be based on the gestational age. At each prenatal visit, the exercise program for 4 weeks later will be given to pregnant women. weekly How to do exercises, will be controlled by  researcher trough  phone call . Exercises will be continued until 35 weeks of gestational age. Routine prenatal care visits   will be done during pregnancy. Pregnant women whenever they want, they  can be removed from the intervention group. If any of the interventions group exits, a new sample will be replaced. Intervention 2: The Control group :This group will be had  usual physical activity during pregnancy. Routine prenatal care visits  will be done during pregnancy. Pregnant women whenever they want, they  can be removed from the control group.                                              If any of the control group exits, a new sample will be replaced.</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 Data will be published in total not individual levels; because of the objectives of the study there is no need to publish individual characteristics and data of the participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Lida Moghaddam-Banaem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al Ahmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3857</telephone>
        <email>moghaddamb@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Lida Moghaddam-Banaem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al Ahmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3857</telephone>
        <email>moghaddamb@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women in 11-16 weeks of gestation
Body Mass Index (BMI) of 25 -29.9 Kg / m2 before pregnancy or in the first prenatal visit
Mother's age 18-35 years old
Single pregnancy
Residing in Tehran
Iranian citizenship</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Chronic and systemic diseases
Any of the absolute and relative contraindications of pregnancy exercises according to ACOG Guideline
Diabetes (type I, type II)
Use of psychological drugs, Opiate products or alcohol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O13.9</hc_code>
      <hc_code>O99.210</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gestational [pregnancy-induced] hypertension without significant proteinuria, unspecified trimester</hc_keyword>
      <hc_keyword>Obesity complicating pregnancy, unspecified trimester</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: The group, after training exercise , begin  a Specific combined exercise schedule including aerobic, resistance and endurance activities from the 16 weeks of gestational age.The combination of exercises will be based on the gestational age. At each prenatal visit, the exercise program for 4 weeks later will be given to pregnant women. weekly How to do exercises, will be controlled by  researcher trough  phone call . Exercises will be continued until 35 weeks of gestational age. Routine prenatal care visits   will be done during pregnancy. Pregnant women whenever they want, they  can be removed from the intervention group. If any of the interventions group exits, a new sample will be replaced.</i_keyword>
      <i_keyword>The Control group :This group will be had  usual physical activity during pregnancy. Routine prenatal care visits  will be done during pregnancy. Pregnant women whenever they want, they  can be removed from the control group.                                              If any of the control group exits, a new sample will be replaced.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TNF-α. Timepoint: 11-16 weeks , 24-28 weeks and delivery time. Method of measurement: Blood sample of venous.</prim_outcome>
      <prim_outcome>Mean Arterial Pressure. Timepoint: 11-16, and 24-28 weeks of gestation, labor. Method of measurement: Measuring systolic and diastolic blood pressure.</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>Tarbiat  Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-05</approval_date>
        <contact_name>National Research Ethics Committee</contact_name>
        <contact_address>Jalal Al-Ahmad Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
