<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/NCT01696201</url>
  </required_header>
  <id_info>
    <org_study_id>Pregnancy outcomes</org_study_id>
    <nct_id>NCT01696201</nct_id>
  </id_info>
  <brief_title>Effect of Physical Exercise Program on Outcomes and Level of Depression</brief_title>
  <official_title>Effect of a Supervised Exercise Program During Whole Pregnancy on Outcomes and Level of Depression. A 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>
      Due to physical and physiological changes that occur in pregnant women, depression is very&#xD;
      common during this period. Recent research findings indicate that antenatal maternal mood&#xD;
      state impacts on babies health. Nowadays, many researchers are focussed on examining the&#xD;
      effects of physical exercise on foetal and maternal outcomes.&#xD;
&#xD;
      The main aim of this study was to assess the effectiveness of a supervised exercise program&#xD;
      consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises&#xD;
      (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the&#xD;
      prevention and treatment of depression in pregnant women. Additionally, the other purpose of&#xD;
      the study was to analyze the effects of depression and physical exercise on outcomes.&#xD;
&#xD;
      Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a&#xD;
      better mood state than pregnant women who are sedentary, without having any negative effect&#xD;
      on outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKROUND: Recent studies have estimated the prevalence of depression during pregnancy at&#xD;
      between 10% and 30%. This state can produce negative effects on the fetus as:&#xD;
&#xD;
        -  Affect cerebral development&#xD;
&#xD;
        -  Increase the risk of preterm birth and low birth weight&#xD;
&#xD;
        -  Increase the risk of childhood overweight problems&#xD;
&#xD;
        -  Adverse impact on the cognitive, emotional, social, and behavioural development of&#xD;
           infants&#xD;
&#xD;
      Due to the possible side effect of antidepressants on mother and fetus, its necessary to&#xD;
      examine alternative solutions to this state.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2009</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>Change from level of depression at the end of the pregnancy</measure>
    <time_frame>Up to 36 weeks</time_frame>
    <description>The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all pregnant women at the beginning and at the end of their pregnancies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal outcome</measure>
    <time_frame>Time spending in each stages of labor</time_frame>
    <description>Time of stages of labor (min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal outcome</measure>
    <time_frame>1-5 minutes after labor</time_frame>
    <description>Apgar score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Maternal outcome</measure>
    <time_frame>Between 12 and 38 weeks</time_frame>
    <description>Constipation (yes/not)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Control group</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>
    <description>Exercise program</description>
  </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&#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>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>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 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, outcomes, depression, mood, physical exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT01696201
org study id: Pregnancy outcomes
nct id: NCT01696201
lead sponsor: 
has dmc: Yes
Due to physical and physiological changes that occur in pregnant women, depression is very
      common during this period. Recent research findings indicate that antenatal maternal mood
      state impacts on babies health. Nowadays, many researchers are focussed on examining the
      effects of physical exercise on foetal and maternal outcomes.

      The main aim of this study was to assess the effectiveness of a supervised exercise program
      consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises
      (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the
      prevention and treatment of depression in pregnant women. Additionally, the other purpose of
      the study was to analyze the effects of depression and physical exercise on outcomes.

      Hypothesis: Pregnant women who do regular exercise during their pregnancies would have a
      better mood state than pregnant women who are sedentary, without having any negative effect
      on outcomes.
BACKROUND: Recent studies have estimated the prevalence of depression during pregnancy at
      between 10% and 30%. This state can produce negative effects on the fetus as:

        -  Affect cerebral development

        -  Increase the risk of preterm birth and low birth weight

        -  Increase the risk of childhood overweight problems

        -  Adverse impact on the cognitive, emotional, social, and behavioural development of
           infants

      Due to the possible side effect of antidepressants on mother and fetus, its necessary to
      examine alternative solutions to this state.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change from level of depression at the end of the pregnancy
time frame: Up to 36 weeks
description: The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all pregnant women at the beginning and at the end of their pregnancies
measure: Maternal outcome
time frame: Time spending in each stages of labor
description: Time of stages of labor (min)
measure: Fetal outcome
time frame: 1-5 minutes after labor
description: Apgar score
measure: Maternal outcome
time frame: Between 12 and 38 weeks
description: Constipation (yes/not)
arm group label: Control group
arm group type: No Intervention
description: Sedentary pregnant women
arm group label: Exercise group
arm group type: Experimental
description: Exercise program
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: 913364020
email: barakatruben@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Technical University of Madrid
investigator full name: María Perales Santaella
investigator title: PhD student
mesh term: Depression