<?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>IRCT20230920059475N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-24</date_registration>
      <primary_sponsor>The University of Isfahan</primary_sponsor>
      <public_title>The effect of eight weeks of aquatic training on metabolic factors, body composition, sleep quality and back pain in pregnant women with gestinal diabetes mellitus</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of aquatic training on metabolic factors, body composition, sleep quality and back pain in pregnant women with gestinal diabetes mellitus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72785</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization
The samples will be determined by the random block method with 4-blocks and using the random numbers table of Allocation Random software. Blocking and allocation sequence for concealment will be done by a person not involved in the research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: There are three sessions per week of the training program in the water, which lasts for 75 minutes. The exercise program is carried out under the supervision of a hydrotherapy specialist. Intervention 2: Control group: They do not have any sports activities and only do daily activities.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Usage data is shared after being de-identified.

When:
The access period starts 6 months after the publication of the results

To whom:
Community members, clinical experts and sports science researchers

Conditions:
The results obtained using statistical analysis show the effectiveness of the exercise program and only pregnant women with diabetes are allowed to use this exercise protocol.

Where to obtain:
Researcher (Shahla Lasani) Isfahan, Isfahan University, Faculty of Sports Sciences
Corresponding author (Mehdi Kargari Fardi), Isfahan University, Faculty of Sports Sciences

How to obtain:
The implementation of the research design lasts for 10 weeks, the first and tenth weeks are related to the measurement of the study variables, and the exercise program is eight weeks, with three sessions per week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Kargari Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences - Isfahan University - Hazarjarib Street - Isfahan City - Isfahan Province</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۴۱</zip>
        <telephone>+98 31 3793 2128</telephone>
        <email>m.kargarfard@spr.ui.ac.ir</email>
        <affiliation>The University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Kargari Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences - Isfahan University - Hazarjarib Street - Isfahan City - Isfahan Province</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۴۱</zip>
        <telephone>+98 31 3793 2128</telephone>
        <email>m.kargarfard@spr.ui.ac.ir</email>
        <affiliation>The University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>They all have general health and their gestational diabetes will be confirmed by a doctor.
All participants are between the ages of 20 and 40.
All participants follow their normal diet.
All participants have not participated in sports activities in the last six months.
All participants do not have a history of premature birth.
All participants do not need prenatal care.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absent more than 2 to 5 training sessions alternately during the training period.
Musculoskeletal injury occurs during the exercise program
Use other sports supplements.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>024.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus arising in pregnancy</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: There are three sessions per week of the training program in the water, which lasts for 75 minutes. The exercise program is carried out under the supervision of a hydrotherapy specialist.</i_keyword>
      <i_keyword>Control group: They do not have any sports activities and only do daily activities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight measurement. Timepoint: It is measured before and after eight weeks. Method of measurement: Using SECA scales made in Germany.</prim_outcome>
      <prim_outcome>Body mass index measurement. Timepoint: It is measured before and after eight weeks. Method of measurement: Height to weight ratio.</prim_outcome>
      <prim_outcome>Fat percent measurement. Timepoint: It is measured before and after eight weeks. Method of measurement: Body composition device.</prim_outcome>
      <prim_outcome>Fasting blood glucose measurement. Timepoint: It is measured before and after eight weeks. Method of measurement: Blood sampling is taken by expert in laboratory.</prim_outcome>
      <prim_outcome>Blood insulin measurement. Timepoint: It is measured before and after eight weeks. Method of measurement: Blood sampling is taken by expert in laboratory.</prim_outcome>
      <prim_outcome>Insulin resistance measurement. Timepoint: It is measured before and after eight weeks. Method of measurement: Blood sampling is taken by expert in laboratory.</prim_outcome>
      <prim_outcome>Measurement of glycosylated hemoglobin. Timepoint: It is measured before and after eight weeks. Method of measurement: Blood sampling is taken by expert in laboratory.</prim_outcome>
      <prim_outcome>Measurement of sleep quality. Timepoint: It is measured before and after eight weeks. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</prim_outcome>
      <prim_outcome>Back pain measurement. Timepoint: It is measured before and after eight weeks. Method of measurement: OSWESTRY DISABILITY INDEX Questionnaire.</prim_outcome>
      <prim_outcome>Measurement of pelvic girdle pain. Timepoint: It is measured before and after eight weeks. Method of measurement: Pelvic Girdle 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>The University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-26</approval_date>
        <contact_name>National Committee on Ethics in Biomedical Research</contact_name>
        <contact_address>Central Building of Ministry of Health and Medical Education,simaye iran street, Qods Township (West), Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
