<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/NCT04501302</url>
  </required_header>
  <id_info>
    <org_study_id>TrAEcho01</org_study_id>
    <nct_id>NCT04501302</nct_id>
  </id_info>
  <brief_title>Effect of Four Exercises on the Inter-recti Distance in Women</brief_title>
  <acronym>Traecho</acronym>
  <official_title>Effect of Four Abdominal and Pelvic Exercises on the Inter-recti Distance in Women: an Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>APOR B de Gasquet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>APOR B de Gasquet</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diastasis rectus abdominis (DRA) is defined as an excessive separation between the two&#xD;
      abdominal rectus muscles. It is generally quantified by the inter-recti distance. In&#xD;
      postpartum women, the prevalence of diastasis is 60% six weeks after delivery.&#xD;
&#xD;
      The increase in the inter-recti distance has been associated with a decrease in strength and&#xD;
      endurance of the trunk flexors and rotators (p &lt; 0.05). Exercise during pregnancy has been&#xD;
      shown to be helpful in the treatment of DRA. Nevertheless, there is still not strong evidence&#xD;
      to establish what kind of exercise should be recommended during pregnancy and in postpartum.&#xD;
&#xD;
      The aim of this study is to compare the morphological and functional changes of the linea&#xD;
      alba during four exercises.&#xD;
&#xD;
      Inter-recti distance, linea alba thickness and distortion index will be measured at rest, as&#xD;
      well as during 4 exercises (draw in maneuver, crunch, pelvic floor muscle contraction and a&#xD;
      &quot;de Gasquet&quot; exercise). Subgroup analysis will be performed to determine if the presence or&#xD;
      absence of an abdominal diastasis has an influence on these outcomes.&#xD;
&#xD;
      A cross-sectional pilot study will be carried out. The main outcome measure will the&#xD;
      inter-recti distance. Secondary outcomes will be the thickness of linea alba and distortion&#xD;
      index.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 25, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Inter-recti distance</measure>
    <time_frame>During the exercise</time_frame>
    <description>The distance between the two medial borders of rectus abdominis muscles is measured using ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Linea alba thickness</measure>
    <time_frame>During the exercise</time_frame>
    <description>Linea alba thickness is measured using ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distortion index of the linea alba</measure>
    <time_frame>During the exercise</time_frame>
    <description>Average deviation of the linea alba from the shortest path between the recti measured using ultrasound</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Transversus abdominis thickness</measure>
    <time_frame>During the exercise</time_frame>
    <description>Transversus abdominis thickness at 1cm lateral from the fascia transversalis measured using ultrasound</description>
  </other_outcome>
  <other_outcome>
    <measure>Current lumbopelvic pain intensity</measure>
    <time_frame>During the assessement</time_frame>
    <description>Current lumbopelvic pain will be measured using a visual analog scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Acute lumbopelvic pain severity</measure>
    <time_frame>During the assessement</time_frame>
    <description>The participants will be asked about their lumbopelvic pain mean intensity in the last week using a visual analog scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Chronic lumbopelvic pain severity</measure>
    <time_frame>During the assessement</time_frame>
    <description>The participants will be asked about their lumbopelvic pain mean intensity in the last 6 months using a visual analog scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Urinary symptoms</measure>
    <time_frame>During the assessement</time_frame>
    <description>Urinary symptoms will be measured using the Urinary Symptom Profile questionnaires</description>
  </other_outcome>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Diastasis, Muscle</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult parous women attending to several physiotherapy centers in Paris will be recruited&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults&#xD;
&#xD;
          -  Parous&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Accepting to participe in the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under curatorship&#xD;
&#xD;
          -  Persons deprived of their liberty by judicial or administrative decision&#xD;
&#xD;
          -  Having intellectual limitations that may limit the understanding of questionnaires or&#xD;
             exercises&#xD;
&#xD;
          -  With limitations in understanding the French language&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  History of pelvic / spine fractures&#xD;
&#xD;
          -  History of pelvic surgery&#xD;
&#xD;
          -  History of spinal surgery&#xD;
&#xD;
          -  History of abdominal surgery&#xD;
&#xD;
          -  History of lower limbs weakness, changes in osteotendinous reflexes or loss of&#xD;
             sensitivity&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Montserrat Rejano-Campo, MSc</last_name>
    <phone>0033627083914</phone>
    <email>montserejano@gmail.com</email>
  </overall_contact>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transversus abdominis, diastasis rectus abdominis, exercise, pelvic floor muscles</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diastasis, Muscle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04501302
org study id: TrAEcho01
nct id: NCT04501302
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Diastasis rectus abdominis (DRA) is defined as an excessive separation between the two
      abdominal rectus muscles. It is generally quantified by the inter-recti distance. In
      postpartum women, the prevalence of diastasis is 60% six weeks after delivery.

      The increase in the inter-recti distance has been associated with a decrease in strength and
      endurance of the trunk flexors and rotators (p < 0.05). Exercise during pregnancy has been
      shown to be helpful in the treatment of DRA. Nevertheless, there is still not strong evidence
      to establish what kind of exercise should be recommended during pregnancy and in postpartum.

      The aim of this study is to compare the morphological and functional changes of the linea
      alba during four exercises.

      Inter-recti distance, linea alba thickness and distortion index will be measured at rest, as
      well as during 4 exercises (draw in maneuver, crunch, pelvic floor muscle contraction and a
      "de Gasquet" exercise). Subgroup analysis will be performed to determine if the presence or
      absence of an abdominal diastasis has an influence on these outcomes.

      A cross-sectional pilot study will be carried out. The main outcome measure will the
      inter-recti distance. Secondary outcomes will be the thickness of linea alba and distortion
      index.
observational model: Other
time perspective: Prospective
measure: Inter-recti distance
time frame: During the exercise
description: The distance between the two medial borders of rectus abdominis muscles is measured using ultrasound
measure: Linea alba thickness
time frame: During the exercise
description: Linea alba thickness is measured using ultrasound
measure: Distortion index of the linea alba
time frame: During the exercise
description: Average deviation of the linea alba from the shortest path between the recti measured using ultrasound
measure: Transversus abdominis thickness
time frame: During the exercise
description: Transversus abdominis thickness at 1cm lateral from the fascia transversalis measured using ultrasound
measure: Current lumbopelvic pain intensity
time frame: During the assessement
description: Current lumbopelvic pain will be measured using a visual analog scale
measure: Acute lumbopelvic pain severity
time frame: During the assessement
description: The participants will be asked about their lumbopelvic pain mean intensity in the last week using a visual analog scale
measure: Chronic lumbopelvic pain severity
time frame: During the assessement
description: The participants will be asked about their lumbopelvic pain mean intensity in the last 6 months using a visual analog scale
measure: Urinary symptoms
time frame: During the assessement
description: Urinary symptoms will be measured using the Urinary Symptom Profile questionnaires
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Montserrat Rejano-Campo, MSc
phone: 0033627083914
email: montserejano@gmail.com
responsible party type: Sponsor
mesh term: Diastasis, Muscle
sharing ipd: Undecided