<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/NCT04477915</url>
  </required_header>
  <id_info>
    <org_study_id>KaratayUH</org_study_id>
    <nct_id>NCT04477915</nct_id>
  </id_info>
  <brief_title>Effects of Two Different Exercise Practices on Maximum Oxygen Uptake and Pulmonary Function</brief_title>
  <official_title>The Effects of Auxiliary Respiratory Muscles Exercises and Core Stabilization Exercises on Maximum Oxygen Uptake and Pulmonary Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KTO Karatay University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KTO Karatay 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>
      Cardiopulmonary capacities of individuals are an indication of both the individual's exercise&#xD;
      capacity and endurance. The most important indicator of cardiopulmonary capacity is maximum&#xD;
      oxygen uptake and respiratory parameters. Auxiliary respiratory muscles exercises and core&#xD;
      stabilization exercises have a place in increasing the maximum oxygen uptake. There are&#xD;
      studies investigating the effects of respiratory muscle training and core stabilization&#xD;
      training on maximum oxygen uptake in the literature. However, there is no study in the&#xD;
      literature comparing the effects of auxiliary respiratory muscles exercises and core&#xD;
      stabilization exercises on maximum oxygen uptake and respiratory parameters. Thanks to the&#xD;
      findings to be obtained from our study, it is aimed to contribute to the literature with&#xD;
      objective, evidence-based results in this field.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be carried out on volunteers after the approval of the ethics committee.&#xD;
      Before the research, individuals and / or their relatives will be informed about the purpose&#xD;
      and content of the study. Volunteer individuals between the ages of 18-25 without any known&#xD;
      health problems will be included in the study after obtaining their informed consent.&#xD;
&#xD;
      Participants will be randomly divided into three groups: control group, core stabilization&#xD;
      exercises and auxiliary respiratory muscles exercises.&#xD;
&#xD;
      In the core stabilization exercises and auxiliary respiratory muscles exercises groups,&#xD;
      exercises will be carried out under the supervision of a physiotherapist 3 days in a week&#xD;
      separate time periods. Core stabilization exercise include, plank, lateral plank, swimmer,&#xD;
      flutter kick and bridge exercises. Auxiliary respiratory exercises include, strengthening and&#xD;
      stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus&#xD;
      anterior muscles. Our study will take 6 weeks. The demographic information of the&#xD;
      participants will be recorded and the VO2max values of the participants before and after the&#xD;
      study will be measured with the H / P Cosmos Mercury Med device using the balke protocol.&#xD;
      Respiratory function tests of participants will be measured with Cosmed Fitmate Med device&#xD;
      before and after the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 25, 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>Other</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Maximum oxygen uptake at 6 weeks</measure>
    <time_frame>Baseline and week 6</time_frame>
    <description>the VO2max values of the participants before and after the study will be measured with the H / P Cosmos Mercury Med device using the Balke Ware protocol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Pulmonary function tests at 6 weeks</measure>
    <time_frame>Baseline and week 6</time_frame>
    <description>Forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC), vital capacity and maximum voluntary ventilation (MVV) values of the participants will be measured with Cosmed Fitmate Med device before and after the study.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Core stabilization Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises. Exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Our study will take 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Auxiliary respiratory exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles. exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Our study will take 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Core exercises</intervention_name>
    <description>Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises.</description>
    <arm_group_label>Core stabilization Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Auxiliary respiratory exercises</intervention_name>
    <description>Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles.</description>
    <arm_group_label>Auxiliary respiratory exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy individuals without any known health problems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction, Unstable angina, Uncontrolled cardiac arrhythmias,&#xD;
             Endocarditis, Various symptomatic aortic stenosis, Acute pulmonary embolism, pulmonary&#xD;
             infarction and deep vein thrombosis, Acute myocarditis, pericarditis, physically not&#xD;
             enough fit to test safely&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hasan Gerçek</last_name>
    <role>Principal Investigator</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KTO Karatay University</name>
      <address>
        <city>Konya</city>
        <zip>42020</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Core stabilization</keyword>
  <keyword>Auxiliary Respiratory Muscles</keyword>
  <keyword>Maximum oxygen uptake</keyword>
  <keyword>Pulmonary function</keyword>
  <!-- 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/NCT04477915
org study id: KaratayUH
nct id: NCT04477915
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiopulmonary capacities of individuals are an indication of both the individual's exercise
      capacity and endurance. The most important indicator of cardiopulmonary capacity is maximum
      oxygen uptake and respiratory parameters. Auxiliary respiratory muscles exercises and core
      stabilization exercises have a place in increasing the maximum oxygen uptake. There are
      studies investigating the effects of respiratory muscle training and core stabilization
      training on maximum oxygen uptake in the literature. However, there is no study in the
      literature comparing the effects of auxiliary respiratory muscles exercises and core
      stabilization exercises on maximum oxygen uptake and respiratory parameters. Thanks to the
      findings to be obtained from our study, it is aimed to contribute to the literature with
      objective, evidence-based results in this field.
The study will be carried out on volunteers after the approval of the ethics committee.
      Before the research, individuals and / or their relatives will be informed about the purpose
      and content of the study. Volunteer individuals between the ages of 18-25 without any known
      health problems will be included in the study after obtaining their informed consent.

      Participants will be randomly divided into three groups: control group, core stabilization
      exercises and auxiliary respiratory muscles exercises.

      In the core stabilization exercises and auxiliary respiratory muscles exercises groups,
      exercises will be carried out under the supervision of a physiotherapist 3 days in a week
      separate time periods. Core stabilization exercise include, plank, lateral plank, swimmer,
      flutter kick and bridge exercises. Auxiliary respiratory exercises include, strengthening and
      stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus
      anterior muscles. Our study will take 6 weeks. The demographic information of the
      participants will be recorded and the VO2max values of the participants before and after the
      study will be measured with the H / P Cosmos Mercury Med device using the balke protocol.
      Respiratory function tests of participants will be measured with Cosmed Fitmate Med device
      before and after the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in Maximum oxygen uptake at 6 weeks
time frame: Baseline and week 6
description: the VO2max values of the participants before and after the study will be measured with the H / P Cosmos Mercury Med device using the Balke Ware protocol.
measure: Change from baseline in Pulmonary function tests at 6 weeks
time frame: Baseline and week 6
description: Forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC), vital capacity and maximum voluntary ventilation (MVV) values of the participants will be measured with Cosmed Fitmate Med device before and after the study.
arm group label: Core stabilization Exercise
arm group type: Experimental
description: Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises. Exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Our study will take 6 weeks.
arm group label: Auxiliary respiratory exercises
arm group type: Experimental
description: Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles. exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Our study will take 6 weeks.
arm group label: Control
arm group type: No Intervention
description: Control Group
intervention type: Other
intervention name: Core exercises
description: Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises.
arm group label: Core stabilization Exercise
intervention type: Other
intervention name: Auxiliary respiratory exercises
description: Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles.
arm group label: Auxiliary respiratory exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hasan Gerçek
role: Principal Investigator
affiliation: KTO Karatay University
facility: 
country: Turkey
responsible party type: Sponsor