<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01723098</url>
  </required_header>
  <id_info>
    <org_study_id>Maternal cardiovascular system</org_study_id>
    <nct_id>NCT01723098</nct_id>
  </id_info>
  <brief_title>Effect of Regular Exercise on Maternal Cardiovascular System During Pregnancy</brief_title>
  <official_title>Effect of Supervised Exercise Program on Cardiovascular Function and Structure in Pregnant Women. Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Madrid</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of this study was to analysed the security of a supervised exercise program on&#xD;
      maternal cardiovascular system and assess the positive effects of this program on maternal&#xD;
      cardiovascular function and structure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During pregnancy, the effectiveness of cardiovascular system is necessary to the growth and&#xD;
      development of the baby, however many changes in it occur during this period.&#xD;
&#xD;
      Physical exercise has shown to have a positive effect on cardiovascular structure and&#xD;
      function in the general population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2009</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from cardiovascular function at the end of pregnancy: Stroke volume</measure>
    <time_frame>Weeks 20 and 34</time_frame>
    <description>Data were collected in second and third trimester</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from cardiovascular structure at the end of the pregnancy</measure>
    <time_frame>Weeks 20 and 34</time_frame>
    <description>Data were collected in second and third trimester</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal and fetal pregnancy outcomes</measure>
    <time_frame>During pregnancy. At the moment of delivery.</time_frame>
    <description>Gestational age, type of delivery, duration of labor, maternal weight gain, birth weight, size and head circumference of new born, pH of umbilical cord, Apgar Score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Sedentary pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise group</intervention_name>
    <description>Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training&#xD;
Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.</description>
    <arm_group_label>Exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being healthy and able to exercise following American College of Obstetricians and&#xD;
             Gynecologists (ACOG) guidelines&#xD;
&#xD;
          -  Being able to communicate in spanish&#xD;
&#xD;
          -  Giving birth at Hospital Universitario de Fuenlabrada and Hospital Universitario&#xD;
             Severo Ochoa (Madrid).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiparity&#xD;
&#xD;
          -  Obstetrician complications&#xD;
&#xD;
          -  Being interested in the study after 18 weeks&#xD;
&#xD;
          -  Not being regular in physical exercise program&#xD;
&#xD;
          -  Younger than 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruben Barakat, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Politecnica de Madrid</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria Perales, PhD student</last_name>
    <phone>913364081</phone>
    <email>m.perales.santaella@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ruben Barakat, PhD</last_name>
    <phone>913364120</phone>
    <email>barakatruben@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universidad Politecnica de Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Perales, PhD student</last_name>
      <phone>913364081</phone>
      <email>m.perales.santaella@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ruben Barakat, PhD</last_name>
      <phone>913364120</phone>
      <email>barakatruben@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Maria Perales, PhD student</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 13, 2014</last_update_submitted>
  <last_update_submitted_qc>November 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Madrid</investigator_affiliation>
    <investigator_full_name>María Perales Santaella</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <keyword>Pregnancy, cardiovascular system, physical exercise</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01723098
org study id: Maternal cardiovascular system
nct id: NCT01723098
lead sponsor: 
has dmc: Yes
The main aim of this study was to analysed the security of a supervised exercise program on
      maternal cardiovascular system and assess the positive effects of this program on maternal
      cardiovascular function and structure
During pregnancy, the effectiveness of cardiovascular system is necessary to the growth and
      development of the baby, however many changes in it occur during this period.

      Physical exercise has shown to have a positive effect on cardiovascular structure and
      function in the general population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Change from cardiovascular function at the end of pregnancy: Stroke volume
time frame: Weeks 20 and 34
description: Data were collected in second and third trimester
measure: Change from cardiovascular structure at the end of the pregnancy
time frame: Weeks 20 and 34
description: Data were collected in second and third trimester
measure: Maternal and fetal pregnancy outcomes
time frame: During pregnancy. At the moment of delivery.
description: Gestational age, type of delivery, duration of labor, maternal weight gain, birth weight, size and head circumference of new born, pH of umbilical cord, Apgar Score.
arm group label: Control
arm group type: No Intervention
description: Sedentary pregnant women
arm group label: Exercise group
arm group type: Experimental
intervention type: Behavioral
intervention name: Exercise group
description: Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training
Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
arm group label: Exercise group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ruben Barakat, PhD
role: Study Director
affiliation: Universidad Politecnica de Madrid
last name: Maria Perales, PhD student
phone: 913364081
email: m.perales.santaella@gmail.com
last name: Ruben Barakat, PhD
phone: 913364120
email: barakatruben@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Technical University of Madrid
investigator full name: María Perales Santaella
investigator title: PhD Student