<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/NCT01723293</url>
  </required_header>
  <id_info>
    <org_study_id>Fetal responses to exercise</org_study_id>
    <nct_id>NCT01723293</nct_id>
  </id_info>
  <brief_title>Fetal Cardiovascular Response to Maternal Exercise During Third Trimester</brief_title>
  <official_title>Effect of a Specific Exercise Program During Whole Pregnancy on Fetal Heart Rate Response to Maternal Effort in Third Trimester. A Randomised 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 purpose of this study was to examine the behavior of the fetal heart rate in response to&#xD;
      different intensities of acute maternal exercise in training and non-training pregnant women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fetal heart rate is considered an important index of fetal well-being, especially during the&#xD;
      third trimester of pregnancy (Rodney JR, Huntley BJ, Rodney WM, 2012). An increase in the FHR&#xD;
      of 5-25 beats per min (bpm) in response to maternal exercise has been established as a normal&#xD;
      reaction(Riemann,Kanstrup Hansen, 2000)however the normal FHR response to maternal exercise&#xD;
      has remained unclear for several reasons&#xD;
&#xD;
      Most of the studies are focused on obtain data in order to examine the fetal heart rate&#xD;
      response to maternal exercise using cardiotocography measurements prior to and following&#xD;
      maternal exercise&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2010</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fetal heart rate</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>Fetal heart rate was measured before and after maternal walking exercise at 40 and 60% MaxHR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fetal outcomes</measure>
    <time_frame>After labor</time_frame>
    <description>Birth weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal outcomes</measure>
    <time_frame>During labor</time_frame>
    <description>Type of delivery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</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>The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.&#xD;
Each session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training.</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&#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>Rubén Barakat, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Politécnica 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>913364020</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>913364020</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>August 2012</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>Fetal heart rate, pregnancy, fetus, cardiovascular system</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/NCT01723293
org study id: Fetal responses to exercise
nct id: NCT01723293
lead sponsor: 
has dmc: Yes
The purpose of this study was to examine the behavior of the fetal heart rate in response to
      different intensities of acute maternal exercise in training and non-training pregnant women
Fetal heart rate is considered an important index of fetal well-being, especially during the
      third trimester of pregnancy (Rodney JR, Huntley BJ, Rodney WM, 2012). An increase in the FHR
      of 5-25 beats per min (bpm) in response to maternal exercise has been established as a normal
      reaction(Riemann,Kanstrup Hansen, 2000)however the normal FHR response to maternal exercise
      has remained unclear for several reasons

      Most of the studies are focused on obtain data in order to examine the fetal heart rate
      response to maternal exercise using cardiotocography measurements prior to and following
      maternal exercise
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Fetal heart rate
time frame: Up to 34 weeks
description: Fetal heart rate was measured before and after maternal walking exercise at 40 and 60% MaxHR
measure: Fetal outcomes
time frame: After labor
description: Birth weight
measure: Maternal outcomes
time frame: During labor
description: Type of delivery
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: The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.
Each session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training.
arm group label: Exercise group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rubén Barakat, PhD
role: Study Director
affiliation: Universidad Politécnica de Madrid.
last name: Maria Perales, PhD student
phone: 913364081
email: m.perales.santaella@gmail.com
last name: Ruben Barakat, PhD
phone: 913364020
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