xml: <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/NCT06042374</url>
    </required_header>
    <id_info>
      <org_study_id>Effect of core stabilization</org_study_id>
      <nct_id>NCT06042374</nct_id>
    </id_info>
    <brief_title>Core Stabilization Training in Elite Athletes</brief_title>
    <official_title>The Effects of Progressive Core Stabilization Training on Anaerobic Performance in Elite Athletes: A Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gulsah Bargi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Izmir Democracy University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The studies in the literature have not sufficiently investigated the effects of core&#xD;
        stabilization training on anaerobic performance. Therefore, this study was planned to&#xD;
        comparatively investigate effects of progressive core stabilization training applied to elite&#xD;
        athletes on anaerobic capacity, anaerobic performance, and fatigue.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In taekwondo, weightlifting, badminton, and volleyball sports branches, strong relationships&#xD;
        between sports performance, anaerobic strength and fatigue parameters have been also shown.&#xD;
        It is clear of the necessity of developing anaerobic capacity using various exercises in&#xD;
        these elite athletes. However, the studies conducted to date have not sufficiently&#xD;
        investigated the effects of core stabilization training on anaerobic performance and fatigue&#xD;
        with more objective methods and enough sample sizes. This study was planned to comparatively&#xD;
        investigate effects of progressive core stabilization training applied to elite athletes on&#xD;
        anaerobic capacity, anaerobic performance, and fatigue.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 21, 2017</start_date>
    <completion_date type="Actual">June 21, 2022</completion_date>
    <primary_completion_date type="Actual">November 21, 2021</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>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Single-blind study; the athletes were not informed about whether they were in the study group or control group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>anaerobic peak power</measure>
      <time_frame>Baseline and after 9-week training</time_frame>
      <description>The power will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>anaerobic mean power</measure>
      <time_frame>Baseline and after 9-week training</time_frame>
      <description>The power will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>squat jump power</measure>
      <time_frame>Baseline and after 9-week training</time_frame>
      <description>It will be evaluated the squat jump test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>active jump power</measure>
      <time_frame>Baseline and after 9-week training</time_frame>
      <description>It will be evaluated the active jump test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fatigue index</measure>
      <time_frame>Baseline and after 9-week training</time_frame>
      <description>The percent of fatigue will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>anaerobic power from 0 to 5 seconds</measure>
      <time_frame>Baseline and after 9-week training</time_frame>
      <description>The power will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>anaerobic capacity from 0 to 30 seconds</measure>
      <time_frame>Baseline and after 9-week training</time_frame>
      <description>The power will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">58</enrollment>
    <condition>Athlete</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Progressive Core Stabilization Training was applied to study group as a group exercise with 5-10 athletes which was planned in the form of 3 days/week for a total of 9 weeks and 27 sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The athletes included in the CG performed only Standard Core Strengthening Exercises.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Progressive Core Stabilization Training</intervention_name>
      <description>The Progressive Core Stabilization Training was applied to study group as a group exercise with 5-10 athletes which was planned in the form of 3 days/week for a total of 9 weeks and 27 sessions. A session consisted of warm-up, core stabilization (30-40 min.), and cool-down exercises. During the training period, exercise volume, degree of difficulty, additional weight, and level of instability (contralateral limb movements and reduction of the support surface, etc.) for each exercise were incrementally increased in four steps.</description>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard Core Strengthening Exercises</intervention_name>
      <description>The athletes included in the CG performed only Standard Core Strengthening Exercises which is the first phase of the Progressive Core Stabilization Training on fixed surfaces (i.e. without pads and balls, with a flat floor and a bench) for 3 days/week and totally 9-week.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  being between 18-25 of age,&#xD;
  &#xD;
            -  actively keeping on a similar technical workout season program,&#xD;
  &#xD;
            -  volunteering to participate in the study,&#xD;
  &#xD;
            -  having at least five years of professional sports history and&#xD;
  &#xD;
            -  being an elite athlete in taekwondo, weightlifting, volleyball, or badminton branches&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having had any pathological condition and/or surgical procedure of the column&#xD;
               vertebral and extremities within the last three months,&#xD;
  &#xD;
            -  having had any serious orthopedic or systemic condition that could prevent doing and&#xD;
               continuing exercises&#xD;
  &#xD;
            -  discontinuing exercise training for more than three sessions.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>GÜLŞAH BAŞANDAÇ, PhD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mok Academy, Istanbul</affiliation>
    </overall_official>
    <overall_official>
      <last_name>GÜLŞAH BARĞI, Assoc. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Izmir Democracy University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>VOLGA BAYRAKCI TUNAY, Prof. Dr.</last_name>
      <role>Study Director</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hacettepe University</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Yang CY, Thurston TS, Cho EH, Cho JY, Koo JH. Non-combative taekwondo evokes highly anaerobic physiological responses in elite-level athletes: potential evidence for a new training modality. J Sports Med Phys Fitness. 2019 Sep;59(9):1450-1457. doi: 10.23736/S0022-4707.18.09365-9. Epub 2018 Dec 13.</citation>
      <PMID>30543275</PMID>
    </reference>
    <reference>
      <citation>Lee B, McGill S. The effect of core training on distal limb performance during ballistic strike manoeuvres. J Sports Sci. 2017 Sep;35(18):1-13. doi: 10.1080/02640414.2016.1236207. Epub 2016 Oct 3.</citation>
      <PMID>27690749</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Izmir Democracy University</investigator_affiliation>
      <investigator_full_name>Gulsah Bargi</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>athlete</keyword>
    <keyword>weightlifting</keyword>
    <keyword>volleyball</keyword>
    <keyword>racquet sports</keyword>
    <keyword>core stability</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042374
  org study id: Effect of core stabilization
  nct id: NCT06042374
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The studies in the literature have not sufficiently investigated the effects of core
        stabilization training on anaerobic performance. Therefore, this study was planned to
        comparatively investigate effects of progressive core stabilization training applied to elite
        athletes on anaerobic capacity, anaerobic performance, and fatigue.
  In taekwondo, weightlifting, badminton, and volleyball sports branches, strong relationships
        between sports performance, anaerobic strength and fatigue parameters have been also shown.
        It is clear of the necessity of developing anaerobic capacity using various exercises in
        these elite athletes. However, the studies conducted to date have not sufficiently
        investigated the effects of core stabilization training on anaerobic performance and fatigue
        with more objective methods and enough sample sizes. This study was planned to comparatively
        investigate effects of progressive core stabilization training applied to elite athletes on
        anaerobic capacity, anaerobic performance, and fatigue.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  masking description: Single-blind study; the athletes were not informed about whether they were in the study group or control group.
  measure: anaerobic peak power
  time frame: Baseline and after 9-week training
  description: The power will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.
  measure: anaerobic mean power
  time frame: Baseline and after 9-week training
  description: The power will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.
  measure: squat jump power
  time frame: Baseline and after 9-week training
  description: It will be evaluated the squat jump test.
  measure: active jump power
  time frame: Baseline and after 9-week training
  description: It will be evaluated the active jump test.
  measure: fatigue index
  time frame: Baseline and after 9-week training
  description: The percent of fatigue will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.
  measure: anaerobic power from 0 to 5 seconds
  time frame: Baseline and after 9-week training
  description: The power will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.
  measure: anaerobic capacity from 0 to 30 seconds
  time frame: Baseline and after 9-week training
  description: The power will be evaluated using anaerobic endurance test (a 30-second Wingate Anaerobic Power Test) applied on a bicycle ergometer.
  arm group label: Study group
  arm group type: Experimental
  description: The Progressive Core Stabilization Training was applied to study group as a group exercise with 5-10 athletes which was planned in the form of 3 days/week for a total of 9 weeks and 27 sessions.
  arm group label: Control group
  arm group type: Sham Comparator
  description: The athletes included in the CG performed only Standard Core Strengthening Exercises.
  intervention type: Other
  intervention name: Progressive Core Stabilization Training
  description: The Progressive Core Stabilization Training was applied to study group as a group exercise with 5-10 athletes which was planned in the form of 3 days/week for a total of 9 weeks and 27 sessions. A session consisted of warm-up, core stabilization (30-40 min.), and cool-down exercises. During the training period, exercise volume, degree of difficulty, additional weight, and level of instability (contralateral limb movements and reduction of the support surface, etc.) for each exercise were incrementally increased in four steps.
  arm group label: Study group
  intervention type: Other
  intervention name: Standard Core Strengthening Exercises
  description: The athletes included in the CG performed only Standard Core Strengthening Exercises which is the first phase of the Progressive Core Stabilization Training on fixed surfaces (i.e. without pads and balls, with a flat floor and a bench) for 3 days/week and totally 9-week.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: GÜLŞAH BAŞANDAÇ, PhD.
  role: Principal Investigator
  affiliation: Mok Academy, Istanbul
  last name: GÜLŞAH BARĞI, Assoc. Dr.
  role: Principal Investigator
  affiliation: Izmir Democracy University
  last name: VOLGA BAYRAKCI TUNAY, Prof. Dr.
  role: Study Director
  affiliation: Hacettepe University
  facility: 
  country: Turkey
  citation: Yang CY, Thurston TS, Cho EH, Cho JY, Koo JH. Non-combative taekwondo evokes highly anaerobic physiological responses in elite-level athletes: potential evidence for a new training modality. J Sports Med Phys Fitness. 2019 Sep;59(9):1450-1457. doi: 10.23736/S0022-4707.18.09365-9. Epub 2018 Dec 13.
  PMID: 30543275
  citation: Lee B, McGill S. The effect of core training on distal limb performance during ballistic strike manoeuvres. J Sports Sci. 2017 Sep;35(18):1-13. doi: 10.1080/02640414.2016.1236207. Epub 2016 Oct 3.
  PMID: 27690749
  responsible party type: Sponsor-Investigator
  investigator affiliation: Izmir Democracy University
  investigator full name: Gulsah Bargi
  investigator title: Principal Investigator
  sharing ipd: No