<?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>IRCT201008193706N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-11-20</date_registration>
      <primary_sponsor>Research deputy of Tabriz university of medical sciences</primary_sponsor>
      <public_title>Effect of exercise on postpartum depression and postpartum fatigue</public_title>
      <acronym></acronym>
      <scientific_title>Effect of exercise on postnatal depression and fatigue in clients of health centers: A randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3798</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>postpartum depression.</hc_freetext>
      <i_freetext>Intervention 1: C (prenatal and postpartum exercise): women in this group in addition to getting education and doing prenatal exercise will do postpartum exercise in 4 first weeks if they can and then 3 times a week according to the postpartum exercise CD. Intervention 2: B (prenatal exercise): in this group women after getting one session of theoretical and practical education about prenatal exercise (30-40 min) will exercise 3 times a week according to the CD (the materials of this CD was approved by ministry of health and medical education). Intervention 3: A (control): in this group women will get prenatal and postpartum ordinary educations in 3 sessions (each session takes 15-20 minutes).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://www.ncbi.nlm.nih.gov/pubmed/24620734</results_url_link>
      <results_summary>  The effect of a home-based exercise intervention on postnatal depression and fatigue: A randomized controlled trial &lt;br /&gt;&#13;
Mohammadi F, Malakooti J, Babapoor J, Mohammad-Alizadeh-Charandabi S.&lt;br /&gt;&#13;
This study aims to determine the effectiveness of home-based low-intensity stretching and breathing exercises on the reduction of 1 and 2 month post-partum depression (primary outcome) and fatigue (secondary outcome) scores. In this randomized controlled trial, 127 women at 26–32 weeks’ gestation with Edinburgh score less than 15, who attended 14 selected health centres in Tabriz, Iran, were randomly allocated into one of the following three groups: no intervention group, group receiving training for exercise during pregnancy, and group receiving training for exercise during pregnancy and post-partum period until 2 months after delivery. Depression and fatigue scores were measured using the Edinburgh Postnatal Depression Scale and Fatigue Identification Form, respectively, at baseline, 1 month and 2 months after delivery.&lt;br /&gt;&#13;
The data were analysed with SPSS-ver. 13.0 (SPSS Inc, Chicago, IL, USA) using chi-square, Fisher’s exact and Kruskal–Wallis tests. Mean rank of the difference scores of depression and fatigue were not significantly different among the groups, both at 1 and 2 months post-partum (P &gt; 0.05). Therefore, this study did not provide evidence to show that training women to do the home-based exercises during pregnancy or during pregnancy and post-partum period have a&lt;br /&gt;&#13;
preventive effect on post-partum depression and fatigue. However, more studies are needed for making precise judgment.&lt;br /&gt;&#13;
Key words: exercise, postnatal depression, postnatal fatigue.        </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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadi Fatemeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1332 2127</telephone>
        <email>f.mohammadi87@gmail.com</email>
        <affiliation>Tabriz university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Mohammad-Alizadeh Charandabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, South Shariati</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1477 2699</telephone>
        <email>alizades@tbzmed.ac.ir smoalch@yahoo.com</email>
        <affiliation>Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Pregnant women with 26-32 weeks of gestational age and with an alive fetus; 6 years or over education; not currently suffering from disease that would limit exercise (cardiopulmonary, musculoskeletal,...); not currently taking medication that interferes with heart rate response to exercise - no history of threaded to abortion in present pregnancy - no signs of preterm labor in present pregnancy; not having the placenta previa in present pregnancy; nonexistence of fetal malformations; score of less than 15 on the Edinburgh scale; no history of medication and hospitalization for a psychiatric disorder in the past 6 months; not currently participating in regular high tensity exercise (60 min or more in a week); having the CD-player set or computer and knowing how to use it.  Exclusion criteria: obstetric or concomitant disease which would have preclude participation in an exercise program; any condition that would make exercise unsafe or unwise (vaginal bleeding, rupture of membrane, palpitation, dyspnea,....); occurring the fetal or infant death during the study; confirmed fetal malformations.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>deppressive episode</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>C (prenatal and postpartum exercise): women in this group in addition to getting education and doing prenatal exercise will do postpartum exercise in 4 first weeks if they can and then 3 times a week according to the postpartum exercise CD.</i_keyword>
      <i_keyword>B (prenatal exercise): in this group women after getting one session of theoretical and practical education about prenatal exercise (30-40 min) will exercise 3 times a week according to the CD (the materials of this CD was approved by ministry of health and medical education).</i_keyword>
      <i_keyword>A (control): in this group women will get prenatal and postpartum ordinary educations in 3 sessions (each session takes 15-20 minutes).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum depression. Timepoint: 1) befor intervention, 2)  4 and 8 weeks after birth. Method of measurement: Edinburgh scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Potpartum fatigue. Timepoint: 1)before intervention, 2) 4 and 8 weeks after birth. Method of measurement: fatigue identification 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>Research deputy of Tabriz university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-10-14</approval_date>
        <contact_name>Research deputy, Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
