<?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>IRCT20180425039418N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-28</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of pregnancy period sport exercises on the Prevention of Fatigue and Depression in Mothers</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of pregnancy period sport exercises on the Prevention of Fatigue and Depression in Mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31307</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization, individual, packed envelope (by selecting the envelope containing No. 1 patient in the intervention group and by selecting the envelope  containing the number 2 patient in the control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Exercise during pregnancy, fatigue, depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the intervention group was under the prenatal exercise program according to the instructions of clapp et al. The exercise protocol, including warm up, tensile training, flexibility, followed by continuous aerobic walking, all of which focused on the training of pregnant women, was adjusted and performed for at least 30 to 45 minutes, 3 days a week for 8 weeks. The upper and lower parts of the body were exercised for 15 minutes followed by aerobic exercises, including continuous walking, which included 5 minutes of gentle walking in the first session and then increasing one minute to the training time in each session until reaching 15 minutes, from then until the end of the 24 sessions of practice, the activity time was kept constant and in order to go back to the initial state and cool the body from tensile stretches in sitting position for 10 to 15 minutes until the heart rate of the subjects reaches to less than 100 beats per minute. In order to prevent any potential physical problems, the intensity of exercise was 60% of the maximum heart rate per person and heart rate counting 3 times by carotid pulse controlled by the investigator (1). Aerobic exercises were conducted under the supervision of an expert in physical education, midwifery expert and researcher. During the exercises and back to the initial state, with the aim of not feeling tired and optimizing the training environment, soft music was used and after exercise in each session, all subjects used liquids such as water or juice. Intervention 2: Control group: Unlike the test group, all of whom participated in the exercise according to the program, the control group did not recommend a specific training program and emphasized that they should report if they do regular exercises during the study.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shokoufeh Mogharabi Ostad Kalayeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat 1 Alley, Nasr Street 13, Zibashahr</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817978761</zip>
        <telephone>+98 54 3343 1227</telephone>
        <email>sh.mogharabi71@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shokoufeh Mogharabi Ostad Kalayeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat 1 Alley, Nasr Street 13, Zibashahr</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817978761</zip>
        <telephone>+98 54 3343 1227</telephone>
        <email>sh.mogharabi71@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with a gestational age of 16 to 20 weeks (in consultation with a gynecologist)
having a live and healthy embryo
having singleton pregnancy
having a reading and writing education</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>cardiovascular disease
musculoskeletal disorders
Diseases that prohibited exercise in pregnancy such as severe anemia, diabetes, respiratory infections, obesity or severe weight loss, hypertention and hyperthyroidism
history of abortion
signs of preterm labor
Having placenta previa or vaginal bleeding or any symptoms of abortion
high risk pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the intervention group was under the prenatal exercise program according to the instructions of clapp et al. The exercise protocol, including warm up, tensile training, flexibility, followed by continuous aerobic walking, all of which focused on the training of pregnant women, was adjusted and performed for at least 30 to 45 minutes, 3 days a week for 8 weeks. The upper and lower parts of the body were exercised for 15 minutes followed by aerobic exercises, including continuous walking, which included 5 minutes of gentle walking in the first session and then increasing one minute to the training time in each session until reaching 15 minutes, from then until the end of the 24 sessions of practice, the activity time was kept constant and in order to go back to the initial state and cool the body from tensile stretches in sitting position for 10 to 15 minutes until the heart rate of the subjects reaches to less than 100 beats per minute. In order to prevent any potential physical problems, the intensity of exercise was 60% of the maximum heart rate per person and heart rate counting 3 times by carotid pulse controlled by the investigator (1). Aerobic exercises were conducted under the supervision of an expert in physical education, midwifery expert and researcher. During the exercises and back to the initial state, with the aim of not feeling tired and optimizing the training environment, soft music was used and after exercise in each session, all subjects used liquids such as water or juice.</i_keyword>
      <i_keyword>Control group: Unlike the test group, all of whom participated in the exercise according to the program, the control group did not recommend a specific training program and emphasized that they should report if they do regular exercises during the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression of Pregnant Mothers. Timepoint: Before intervention and immediately after intervention. Method of measurement: Beck2 Depression Inventory.</prim_outcome>
      <prim_outcome>Fatigue of pregnant mothers. Timepoint: Before intervention and immediately after intervention. Method of measurement: A multidimensional log of fatigue-short form.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-17</approval_date>
        <contact_name>Kerman University of Medical Sciences</contact_name>
        <contact_address>Campus of Kerman University of Medical Sciences, Beginning of the Axis of Alavi Gardens, Kerman, Iran kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
