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/NCT06041126</url>
    </required_header>
    <id_info>
      <org_study_id>2023-72</org_study_id>
      <nct_id>NCT06041126</nct_id>
    </id_info>
    <brief_title>The Effect of Clinical Parameters on Muscle Oxygenation in Patients With COPD</brief_title>
    <official_title>The Effect of Disease Severity and Respiratory Functions on Muscle Oxygenation in Stable COPD Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bandırma Onyedi Eylül University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bandırma Onyedi Eylül 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 aim of this study is to examine the peripheral muscle oxygenation of patients with&#xD;
        Chronic Obstructive Pulmonary Disease at rest, during submaximal exercise and recovery, and&#xD;
        to examine the effects of disease severity and respiratory functions on peripheral muscle&#xD;
        oxygenations. In this study, the effect of disease severity and respiratory problems on&#xD;
        peripheral muscle metabolism of patients with COPD will be explained.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 24, 2023</start_date>
    <completion_date type="Anticipated">November 23, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 23, 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Muscle oxygenation</measure>
      <time_frame>one day</time_frame>
      <description>The muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Modified Medical Research Council Dyspnea Scale</measure>
      <time_frame>one day</time_frame>
      <description>Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COPD Assessment Test (CAT)</measure>
      <time_frame>one day</time_frame>
      <description>The COPD Assessment Test (CAT) is a new scoring system for COPD patients, which provides a simple method for assessing the impact of COPD on the patient's health. Range of CAT scores from 0-40.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Charlson Comorbidity Index</measure>
      <time_frame>one day</time_frame>
      <description>The Charlson Comorbidity Index was first developed in 1987 by Mary Charlson and colleagues as a weighted index to predict risk of death within 1 year of hospitalization for patients with specific comorbid conditions. Nineteen conditions were included in the index. The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quadriceps muscle strength measurement</measure>
      <time_frame>one day</time_frame>
      <description>Quadriceps muscle strength measurement of the patients will be evaluated with a manual muscle strength measuring device (Lafayette Instrument, USA) and recorded in kg/force. In muscle strength measurements, maximal voluntary isometric contraction (make test), which is reported to be more reliable in the literature and is frequently used, will be used. It will be repeated three times in both lower extremities with an interval of 30 seconds and the highest measurement will be recorded. For quadriceps muscle strength measurement, the patients will be seated on the treatment table with their legs hanging down and the thigh will be fixed by placing a rolled towel under the knee joint of the side to be evaluated. In this position, the patient will be asked to extend until the knee is locked, and the resistance will be given just above the ankle joint.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Six-minute walking test</measure>
      <time_frame>one day</time_frame>
      <description>It is a submaximal exercise capacity measurement test. The patient is asked to walk as briskly as possible on a flat surface of 30 meters for 6 minutes. In our study, the test will be carried out in a 30-meter corridor in accordance with the guidelines.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary Function Test</measure>
      <time_frame>one day</time_frame>
      <description>Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Inspiratory Pressure / Maximum Expiratory Pressure Measurement</measure>
      <time_frame>one day</time_frame>
      <description>Respiratory muscle strength of individuals will be measured using an electronic and portable oral pressure measurement device, according to ATS / ERS criteria, with COSMED brand Pony FX model portable spirometer (COSMED, Italy). It is one of the most commonly used and noninvasive methods for the evaluation of respiratory muscle strength. With this method, maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are measured. MIP and MEP are intraoral pressures measured during maximal breathing against a valve that closes the airway during maximal inspiration and expiration.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <condition>Muscle Oxygenation</condition>
    <condition>Disease Severity</condition>
    <condition>Respiratory Function</condition>
    <arm_group>
      <arm_group_label>Group one</arm_group_label>
      <description>Patients with COPD according to the combined COPD assessment Global Intervention (GOLD) guidelines, participants who are in groups A and B (mild-moderate) will be included in group 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group two</arm_group_label>
      <description>COPD patients according to the combined COPD assessment, according to the &quot;Global Intervention (GOLD) guidelines&quot;, participants who are in groups C and D (severe-very severe) will be included in group 2.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Stable COPD Patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being diagnosed with COPD (according to GOLD Staging: GOLD 1, GOLD 2, GOLD 3, GOLD 4)&#xD;
  &#xD;
            -  Being between the ages of 40-80&#xD;
  &#xD;
            -  Body Mass Index &lt;35&#xD;
  &#xD;
            -  Not having an acute exacerbation in the last 3 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who do not want to participate in the study&#xD;
  &#xD;
            -  Arthritis causing weakness in the lower extremity, neurological disease, deep vein&#xD;
               thrombosis, peripheral arterial disease, muscle weakness, fracture etc. patients with&#xD;
               the condition&#xD;
  &#xD;
            -  Common diseases such as malignancy, pulmonary embolism, vasculitis, collagen tissue&#xD;
               diseases, interstitial fibrosis, severe pneumonia patients with parenchymal&#xD;
               destruction&#xD;
  &#xD;
            -  Patients with severe dyspnea and hemodynamic instability who cannot perform the 6&#xD;
               Minute Walk Test&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Gülhan Yılmaz Gökmen</last_name>
      <phone>+90 266 606 4532</phone>
      <email>ggokmen@bandirma.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation</name>
        <address>
          <city>Balıkesir</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gülhan Yılmaz Gökmen</last_name>
      </contact>
      <investigator>
        <last_name>Canan Demir</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dilber Durmaz</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 27, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bandırma Onyedi Eylül University</investigator_affiliation>
      <investigator_full_name>Gulhan Yilmaz Gokmen</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Chronic Obstructive Pulmonary Disease</keyword>
    <keyword>Muscle Oxygenation</keyword>
    <keyword>Disease Severity</keyword>
    <keyword>Respiratory Function</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <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/NCT06041126
  org study id: 2023-72
  nct id: NCT06041126
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to examine the peripheral muscle oxygenation of patients with
        Chronic Obstructive Pulmonary Disease at rest, during submaximal exercise and recovery, and
        to examine the effects of disease severity and respiratory functions on peripheral muscle
        oxygenations. In this study, the effect of disease severity and respiratory problems on
        peripheral muscle metabolism of patients with COPD will be explained.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Muscle oxygenation
  time frame: one day
  description: The muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21
  measure: Modified Medical Research Council Dyspnea Scale
  time frame: one day
  description: Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.
  measure: COPD Assessment Test (CAT)
  time frame: one day
  description: The COPD Assessment Test (CAT) is a new scoring system for COPD patients, which provides a simple method for assessing the impact of COPD on the patient's health. Range of CAT scores from 0-40.
  measure: Charlson Comorbidity Index
  time frame: one day
  description: The Charlson Comorbidity Index was first developed in 1987 by Mary Charlson and colleagues as a weighted index to predict risk of death within 1 year of hospitalization for patients with specific comorbid conditions. Nineteen conditions were included in the index. The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis.
  measure: Quadriceps muscle strength measurement
  time frame: one day
  description: Quadriceps muscle strength measurement of the patients will be evaluated with a manual muscle strength measuring device (Lafayette Instrument, USA) and recorded in kg/force. In muscle strength measurements, maximal voluntary isometric contraction (make test), which is reported to be more reliable in the literature and is frequently used, will be used. It will be repeated three times in both lower extremities with an interval of 30 seconds and the highest measurement will be recorded. For quadriceps muscle strength measurement, the patients will be seated on the treatment table with their legs hanging down and the thigh will be fixed by placing a rolled towel under the knee joint of the side to be evaluated. In this position, the patient will be asked to extend until the knee is locked, and the resistance will be given just above the ankle joint.
  measure: Six-minute walking test
  time frame: one day
  description: It is a submaximal exercise capacity measurement test. The patient is asked to walk as briskly as possible on a flat surface of 30 meters for 6 minutes. In our study, the test will be carried out in a 30-meter corridor in accordance with the guidelines.
  measure: Pulmonary Function Test
  time frame: one day
  description: Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria.
  measure: Maximum Inspiratory Pressure / Maximum Expiratory Pressure Measurement
  time frame: one day
  description: Respiratory muscle strength of individuals will be measured using an electronic and portable oral pressure measurement device, according to ATS / ERS criteria, with COSMED brand Pony FX model portable spirometer (COSMED, Italy). It is one of the most commonly used and noninvasive methods for the evaluation of respiratory muscle strength. With this method, maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are measured. MIP and MEP are intraoral pressures measured during maximal breathing against a valve that closes the airway during maximal inspiration and expiration.
  arm group label: Group one
  description: Patients with COPD according to the combined COPD assessment Global Intervention (GOLD) guidelines, participants who are in groups A and B (mild-moderate) will be included in group 1.
  arm group label: Group two
  description: COPD patients according to the combined COPD assessment, according to the "Global Intervention (GOLD) guidelines", participants who are in groups C and D (severe-very severe) will be included in group 2.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gülhan Yılmaz Gökmen
  phone: +90 266 606 4532
  email: ggokmen@bandirma.edu.tr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Bandırma Onyedi Eylül University
  investigator full name: Gulhan Yilmaz Gokmen
  investigator title: Assistant Professor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  sharing ipd: No