<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/NCT03769480</url>
  </required_header>
  <id_info>
    <org_study_id>2</org_study_id>
    <nct_id>NCT03769480</nct_id>
  </id_info>
  <brief_title>Investigation of the Relationship Between Pulmonary Function and Muscle Strength in Athletes With Disability</brief_title>
  <official_title>Investigation of the Relationship Between Pulmonary Function and Muscle Strength in Athletes With Disability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Yildirim Beyazıt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Yildirim Beyazıt 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>
      To investigate the relationship between respiratory function and core muscles strength in&#xD;
      athletes with disabilities and compare with healthy athletes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The determination of parameters affecting the performance of high performance athletes that&#xD;
      are effective in performance is very important to determine the physical performance&#xD;
      potential. The body is a kinetic chain and core muscles play an important role in this chain.&#xD;
      The relationship between the performance ability of the athletes and the relationship between&#xD;
      the core muscles and performance abilities and respiratory function is extremely important.&#xD;
      Different functional classifications caused by different barriers (physical, mental or&#xD;
      visual) in many paralympic branches affect physical training because it is directly related&#xD;
      to the classification, performance and training adaptations of an athlete. Determining the&#xD;
      parameters that affect the respiratory function of paralympics is very important to develop a&#xD;
      training program with strategies that can affect the physical performance of athletes and&#xD;
      thus to achieve the desired results in training and competitions. Therefore, the aim of this&#xD;
      study was to investigate the relationship between respiratory muscle strength and core muscle&#xD;
      strength in paralympic athletes (athletes with disability).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">February 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>FVC (the rate of normal value by the spirometer device)</measure>
    <time_frame>2 days</time_frame>
    <description>Functional vital capacity: will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1 ( the rate of normal value by the spirometer device)</measure>
    <time_frame>2 days</time_frame>
    <description>First second Forced Expiratory Volume:will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength (Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)</measure>
    <time_frame>2 days</time_frame>
    <description>Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength (Abdominal Exstansor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)</measure>
    <time_frame>2 days</time_frame>
    <description>Abdominal Extensor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength (Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)</measure>
    <time_frame>2 days</time_frame>
    <description>Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength (Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)</measure>
    <time_frame>2 days</time_frame>
    <description>Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Disabilities Multiple</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>Study Group=Athletes with Disability</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Control Group=Healthy Athletes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscle strength evaluation and Respiratory function Tests</intervention_name>
    <description>Muscle strength evaluation and Respiratory function Tests</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study group is Athletes with disabilities.&#xD;
&#xD;
        The control group is the same sport branches but healthy athletes without any disabilites&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being professional athletes for at least three years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having any lumbar injuries in the last three months,&#xD;
&#xD;
          -  Having systemic problems other than their disabilities(for athletes with&#xD;
             disabilities),&#xD;
&#xD;
          -  Having any disability related to vision and hearing,&#xD;
&#xD;
          -  Acute or chronic respiratory infection,&#xD;
&#xD;
          -  Spinal cord injury level up to the innervation of the abdominal muscles (for&#xD;
             paraplegic athletes).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tuğba Kocahan, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>The Ministry of Youth and Sports, Sports General Directorship, Ankara, Turkey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bihter Akınoğlu</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara Yildirim Beyazıt University</investigator_affiliation>
    <investigator_full_name>Bihter Aslanyurek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Athletes</keyword>
  <keyword>Disability</keyword>
  <keyword>Respiratory Function</keyword>
  <keyword>Core Muscles</keyword>
  <keyword>Sport</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The participants all is national team. Because we can not share the data</ipd_description>
  </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/NCT03769480
org study id: 2
nct id: NCT03769480
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the relationship between respiratory function and core muscles strength in
      athletes with disabilities and compare with healthy athletes.
The determination of parameters affecting the performance of high performance athletes that
      are effective in performance is very important to determine the physical performance
      potential. The body is a kinetic chain and core muscles play an important role in this chain.
      The relationship between the performance ability of the athletes and the relationship between
      the core muscles and performance abilities and respiratory function is extremely important.
      Different functional classifications caused by different barriers (physical, mental or
      visual) in many paralympic branches affect physical training because it is directly related
      to the classification, performance and training adaptations of an athlete. Determining the
      parameters that affect the respiratory function of paralympics is very important to develop a
      training program with strategies that can affect the physical performance of athletes and
      thus to achieve the desired results in training and competitions. Therefore, the aim of this
      study was to investigate the relationship between respiratory muscle strength and core muscle
      strength in paralympic athletes (athletes with disability).
observational model: Cohort
time perspective: Prospective
measure: FVC (the rate of normal value by the spirometer device)
time frame: 2 days
description: Functional vital capacity: will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)
measure: FEV1 ( the rate of normal value by the spirometer device)
time frame: 2 days
description: First second Forced Expiratory Volume:will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)
measure: Muscle strength (Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
time frame: 2 days
description: Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
measure: Muscle strength (Abdominal Exstansor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
time frame: 2 days
description: Abdominal Extensor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
measure: Muscle strength (Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
time frame: 2 days
description: Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
measure: Muscle strength (Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)
time frame: 2 days
description: Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).
arm group label: Study Group
description: Study Group=Athletes with Disability
arm group label: Control Group
description: Control Group=Healthy Athletes
intervention type: Other
intervention name: Muscle strength evaluation and Respiratory function Tests
description: Muscle strength evaluation and Respiratory function Tests
arm group label: Control Group
arm group label: Study Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tuğba Kocahan, Dr
role: Study Chair
affiliation: The Ministry of Youth and Sports, Sports General Directorship, Ankara, Turkey
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara Yildirim Beyazıt University
investigator full name: Bihter Aslanyurek
investigator title: Principal Investigator
sharing ipd: No
ipd description: The participants all is national team. Because we can not share the data