<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/NCT04450615</url>
  </required_header>
  <id_info>
    <org_study_id>ERC-006/2020</org_study_id>
    <nct_id>NCT04450615</nct_id>
  </id_info>
  <brief_title>Core Exercises Effects on Muscle Imbalances</brief_title>
  <official_title>Effects of a 5-week Core Training Program on Core Muscles' Imbalances</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Athanasios Ellinoudis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</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>
      This study aims in investigating the effects of a core muscles' strengthening program on core&#xD;
      muscles' atrophy and contraction ability. Twenty healthy adults recruited and randomly&#xD;
      assigned to either a 5-week training group developed to activate and strengthen local trunk&#xD;
      muscles or a control group. The training program includes isometric bridging exercises from&#xD;
      various positions and dynamic exercises for lumbopelvic stability. Core muscles' thickness&#xD;
      will be assessed at rest and contracting conditions, prior and after the intervention, using&#xD;
      ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 136 male and female adults, members of local gyms, were initially invited for&#xD;
      participation in the study after giving their written consent. After a second contact with&#xD;
      the participants, forms regarding the inclusion and exclusion criteria were sent for&#xD;
      completion.&#xD;
&#xD;
      Of the 136 that initially answered positively for participation, 62 did not meet the&#xD;
      inclusion criteria, based on their reports and the clinical examination by a health&#xD;
      professional. Of the remaining 74 participants, 32 were excluded because of previous low back&#xD;
      pain incidents and other recent musculoskeletal injuries that led to rehabilitation, while 22&#xD;
      decided to not participate for personal reasons.&#xD;
&#xD;
      The remaining 20 participants were randomly allocated to either training group or&#xD;
      intervention group, by a neutral, blinded investigator who had no involvement and was unaware&#xD;
      of the study purposes. The intervention group will be trained and supervised by a certified&#xD;
      fitness instructor in a gym class, who will be responsible for the correct execution of the&#xD;
      exercises. The duration of the intervention will be 5 weeks, 3 times a week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">August 5, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transversus abdominis (TrA) muscle thickness at rest and contraction</measure>
    <time_frame>Change from baseline assessment at 5 weeks</time_frame>
    <description>Muscle thickness (mm) is measured using ultrasonography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumbar multifidus (LM) muscle thickness at rest and contraction</measure>
    <time_frame>Change from baseline assessment at 5 weeks</time_frame>
    <description>Muscle thickness (mm) is measured using ultrasonography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contraction thickness ratio (CTR) of TrA and LM muscle</measure>
    <time_frame>Change from baseline assessment at 5 weeks</time_frame>
    <description>This is calculated by subtracting rest thickness from contraction thickness, dividing it to rest thickness and multiplying this value by 100 [(contraction thickness-rest thickness/rest thickness)*100]</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Muscle Atrophy or Weakness</condition>
  <condition>Muscle Contraction</condition>
  <condition>Core Stability</condition>
  <arm_group>
    <arm_group_label>Training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first part of the program aims in pelvic and hip mobility and includes the following exercises, glute bridge, single-leg glute bridge, side-lying clam, side plank and side plank with hip abduction, on stable surface.&#xD;
The second part consists of exercises for deep and superficial trunk muscles. In the first exercise the participants learn to activate the transversus abdominis muscle from the crook-lying position, by performing abdominal hollow. Other exercises include the front plank, trunk curl-up, trunk curl-up on stable surface and curl-up on unstable surface (Swiss ball).&#xD;
The third part of the program consists of exercises for strengthening the lumbar multifidus muscle. The participants will perform prone trunk extension, superman exercise, quadruped diagonal arm and leg lift, single leg supine bridge and supine bridge on unstable surface (Swiss ball).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants of this group will follow their typical daily routine</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Core stability</intervention_name>
    <description>The exercise protocol consists of the following sets and repetitions, with a total duration of 5 weeks and a frequency of 3 sessions per week.&#xD;
Dynamic exercises: 2 sets of 10 to 15 repetitions (each side) Isometric exercises: 2 sets of 5 to 15 seconds (each side) Week 1- As mentioned above Week 2- Add 1 set Week 3 - Add 5 seconds and 5 repetitions Week 4 - Add 1 set Week 5- Add 5 seconds and 5 repetitions</description>
    <arm_group_label>Training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 45 years old&#xD;
&#xD;
          -  Trained recreationally at least 2 times a week, for the past 3 years&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  No musculoskeletal injuries in the 6 months prior to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chronic low back pain&#xD;
&#xD;
          -  History of hip, pelvic or low back surgery&#xD;
&#xD;
          -  History of acute low back pain with duration at least 1 week, the preceding 6 months&#xD;
&#xD;
          -  Involvement in similar core stability training programs the last 12 moths prior to&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Athanasios Ellinoudis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laboratory of Neuromechanics, Aristotle University of Thessaloniki</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory of Neuromechanics, Department of physical education and sport sciences, Aristotle University of Thessaloniki</name>
      <address>
        <city>Serres</city>
        <zip>62110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Athanasios Ellinoudis</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04450615
org study id: ERC-006/2020
nct id: NCT04450615
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims in investigating the effects of a core muscles' strengthening program on core
      muscles' atrophy and contraction ability. Twenty healthy adults recruited and randomly
      assigned to either a 5-week training group developed to activate and strengthen local trunk
      muscles or a control group. The training program includes isometric bridging exercises from
      various positions and dynamic exercises for lumbopelvic stability. Core muscles' thickness
      will be assessed at rest and contracting conditions, prior and after the intervention, using
      ultrasonography.
A total of 136 male and female adults, members of local gyms, were initially invited for
      participation in the study after giving their written consent. After a second contact with
      the participants, forms regarding the inclusion and exclusion criteria were sent for
      completion.

      Of the 136 that initially answered positively for participation, 62 did not meet the
      inclusion criteria, based on their reports and the clinical examination by a health
      professional. Of the remaining 74 participants, 32 were excluded because of previous low back
      pain incidents and other recent musculoskeletal injuries that led to rehabilitation, while 22
      decided to not participate for personal reasons.

      The remaining 20 participants were randomly allocated to either training group or
      intervention group, by a neutral, blinded investigator who had no involvement and was unaware
      of the study purposes. The intervention group will be trained and supervised by a certified
      fitness instructor in a gym class, who will be responsible for the correct execution of the
      exercises. The duration of the intervention will be 5 weeks, 3 times a week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Transversus abdominis (TrA) muscle thickness at rest and contraction
time frame: Change from baseline assessment at 5 weeks
description: Muscle thickness (mm) is measured using ultrasonography
measure: Lumbar multifidus (LM) muscle thickness at rest and contraction
time frame: Change from baseline assessment at 5 weeks
description: Muscle thickness (mm) is measured using ultrasonography
measure: Contraction thickness ratio (CTR) of TrA and LM muscle
time frame: Change from baseline assessment at 5 weeks
description: This is calculated by subtracting rest thickness from contraction thickness, dividing it to rest thickness and multiplying this value by 100 [(contraction thickness-rest thickness/rest thickness)*100]
arm group label: Training group
arm group type: Experimental
description: The first part of the program aims in pelvic and hip mobility and includes the following exercises, glute bridge, single-leg glute bridge, side-lying clam, side plank and side plank with hip abduction, on stable surface.
The second part consists of exercises for deep and superficial trunk muscles. In the first exercise the participants learn to activate the transversus abdominis muscle from the crook-lying position, by performing abdominal hollow. Other exercises include the front plank, trunk curl-up, trunk curl-up on stable surface and curl-up on unstable surface (Swiss ball).
The third part of the program consists of exercises for strengthening the lumbar multifidus muscle. The participants will perform prone trunk extension, superman exercise, quadruped diagonal arm and leg lift, single leg supine bridge and supine bridge on unstable surface (Swiss ball).
arm group label: Control group
arm group type: No Intervention
description: The participants of this group will follow their typical daily routine
intervention type: Other
intervention name: Core stability
description: The exercise protocol consists of the following sets and repetitions, with a total duration of 5 weeks and a frequency of 3 sessions per week.
Dynamic exercises: 2 sets of 10 to 15 repetitions (each side) Isometric exercises: 2 sets of 5 to 15 seconds (each side) Week 1- As mentioned above Week 2- Add 1 set Week 3 - Add 5 seconds and 5 repetitions Week 4 - Add 1 set Week 5- Add 5 seconds and 5 repetitions
arm group label: Training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Athanasios Ellinoudis, PhD
role: Principal Investigator
affiliation: Laboratory of Neuromechanics, Aristotle University of Thessaloniki
facility: 
country: Greece
responsible party type: Sponsor-Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Athanasios Ellinoudis
investigator title: Principal Investigator
mesh term: Muscular Atrophy
sharing ipd: No