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/NCT06010459</url>
    </required_header>
    <id_info>
      <org_study_id>PBRT</org_study_id>
      <nct_id>NCT06010459</nct_id>
    </id_info>
    <brief_title>Reference Values for the Six-minute Pegboard and Ring Test in Healthy Adults in Turkey</brief_title>
    <official_title>Determination of 6 Minute Pegboard and Ring Test Exercise Test Reference Values in for the Turkish Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ulaş Ar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ankara City Hospital Bilkent</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>
        Supported or unsupported arm activities are widely used in all activities of daily living. 6&#xD;
        PBRT is a valid, reliable, useful, practical and easy-to-apply test that evaluates unassisted&#xD;
        arm endurance in patients with COPD, asthmatics, and healthy individuals. Studies have&#xD;
        recently been conducted showing reference values for 6 PBRT in various populations. 6&#xD;
        Normative values and reference range for PBRT are not available for various ethnicities,&#xD;
        including the Turkish population. Therefore, this study aimed to find reference values for 6&#xD;
        PBRT in the Turkish young and middle-aged individuals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Supported or unassisted arm activities are widely used for all activities of daily living.&#xD;
        They contribute greatly to performing both simple and complex daily tasks such as brushing,&#xD;
        shaving, combing their hair, washing dishes or putting food on shelves; meanwhile, trapezius,&#xD;
        pectoralis minor, scalene and intercostal muscles assist arm positioning.&#xD;
  &#xD;
        Many studies; It has confirmed that patients with COPD have reduced arm exercise capacity and&#xD;
        often experience notable dyspnoea (shortness of breath) and fatigue during arm tasks&#xD;
        important to daily living. Two mechanisms have been suggested underlying this:&#xD;
        neuromechanical dysfunction of the respiratory muscles (diaphragm and accessory respiratory&#xD;
        muscles) (thoracoabdominal asynchrony) and changes in lung volume during activities involving&#xD;
        the upper extremities. During arm exercise, accessory respiratory muscles are used for arm&#xD;
        function and cannot contribute to respiration. This increases the respiratory load of the&#xD;
        mechanically disadvantaged diaphragm and results in thoracoabdominal synchrony and severe&#xD;
        dyspnea. Since the muscles that move the arm and stabilize the trunk are attached to the rib&#xD;
        cage, they increase the resistance of the chest wall and limit the ability to increase tidal&#xD;
        volume during arm activities. These disturbances in ventilatory mechanics result in&#xD;
        termination of arm exercise in patients with COPD at lower workloads compared to healthy&#xD;
        subjects.&#xD;
  &#xD;
        The '6 Minute Pegboard and Ring Test-6PRT' is a valid and reliable, useful, practical and&#xD;
        easy-to-apply test that evaluates unassisted arm endurance in COPD patients, asthmatic&#xD;
        patients and healthy individuals. For the test, patients are asked to carry as many rings as&#xD;
        possible within 6 minutes and the number of rings carried during 6 minutes is recorded as a&#xD;
        score.&#xD;
  &#xD;
        In a study conducted in patients with mild to very severe COPD, a positive correlation was&#xD;
        shown between the 6PRT score and the activity counts evaluated by accelerometer. In addition,&#xD;
        it was determined that the 6PRT score showed a clear relationship with the upper extremity&#xD;
        ADL, and it was concluded that the 6PRT test could be used as an appropriate test for&#xD;
        estimating and demonstrating the improvement of ADL in pulmonary rehabilitation programs.&#xD;
  &#xD;
        Studies have recently been published showing reference values for 6PBRT in Brazilian and&#xD;
        Indian populations. In one of the results, a correlation was found between the score value&#xD;
        and age, showing that younger individuals were able to move more rings than the older group.&#xD;
        In addition, a weak correlation was found between the test score and the level of physical&#xD;
        activity. Normative values and reference range for 6PBRT are not available for various&#xD;
        ethnicities, including the Turkish adults. Therefore, in this study; It is aimed to find&#xD;
        reference values for the 6PBRT test in the Turkish adults.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 4, 2021</start_date>
    <completion_date type="Actual">November 1, 2022</completion_date>
    <primary_completion_date type="Actual">November 1, 2022</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>Unsupported Arm Exercise Capacity and Arm Function/Endurance</measure>
      <time_frame>50 minute</time_frame>
      <description>It will be evaluated with the '6 minute Pegboard and Ring Test-6PRT'. During the test, the patient is asked to sit in front of a pegboard and move as many rings as possible from the two lower holes to the two upper holes, using both hands simultaneously, for 6 minutes. Before the test, participants get used to the test by wearing a few rings. Standardized encouragement is given every minute during the test. The number of rings carried during 6 minutes constitutes the final score. Before and after the test, heart rate and oxygen saturation with pulse oximetry, dyspnea, general fatigue and arm fatigue perception with modified Borg scale are questioned. For the validity of the test, the test will be repeated in the same patient with one week intervals under the same conditions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Arm length of both sides and the arm and forearm circumferences of the dominant arm</measure>
      <time_frame>1 day</time_frame>
      <description>The measurement was done with non-stretch tape</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Level</measure>
      <time_frame>1 day</time_frame>
      <description>It was evaluated with the Human Activity Profile.The level of physical activity of individuals is classifi ed by calculating the adjusted activity score (AAS), resulting in their being classifi ed as inactive or debilitated (AAS &lt; 53 points), moderately active (AAS between 53 and 74 points), or active (AAS &gt; 74 points)</description>
    </secondary_outcome>
    <enrollment type="Actual">132</enrollment>
    <condition>Exercise Tolerance</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy people aged 20-65 years&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To be between the ages of 20-65 years,&#xD;
  &#xD;
            -  Volunteering to participate in the research&#xD;
  &#xD;
            -  To be cooperative&#xD;
  &#xD;
            -  Being between 18.5-40 kg/m2 according to body mass index value&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a neurological disease or other clinical diagnosis that may affect cognitive&#xD;
               status,&#xD;
  &#xD;
            -  Having a musculoskeletal, neurological, cardiopulmonary, neuromuscular or metabolic&#xD;
               disease that may affect exercise performance, or having an advanced orthopedic disease&#xD;
               (such as kyphoscoliosis),&#xD;
  &#xD;
            -  Recent shoulder or thoracic surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ebru Calik Kutukcu, Assoc.Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hacettepe Üniversitesi</name>
        <address>
          <city>Ankara</city>
          <zip>06000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
      <investigator_full_name>Ulaş Ar</investigator_full_name>
      <investigator_title>Investigator</investigator_title>
    </responsible_party>
    <keyword>Upper extremity exercise test</keyword>
    <keyword>six-minute peg board and ring test</keyword>
    <keyword>exercise tolerance</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/NCT06010459
  org study id: PBRT
  nct id: NCT06010459
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Supported or unsupported arm activities are widely used in all activities of daily living. 6
        PBRT is a valid, reliable, useful, practical and easy-to-apply test that evaluates unassisted
        arm endurance in patients with COPD, asthmatics, and healthy individuals. Studies have
        recently been conducted showing reference values for 6 PBRT in various populations. 6
        Normative values and reference range for PBRT are not available for various ethnicities,
        including the Turkish population. Therefore, this study aimed to find reference values for 6
        PBRT in the Turkish young and middle-aged individuals.
  Supported or unassisted arm activities are widely used for all activities of daily living.
        They contribute greatly to performing both simple and complex daily tasks such as brushing,
        shaving, combing their hair, washing dishes or putting food on shelves; meanwhile, trapezius,
        pectoralis minor, scalene and intercostal muscles assist arm positioning.
  
        Many studies; It has confirmed that patients with COPD have reduced arm exercise capacity and
        often experience notable dyspnoea (shortness of breath) and fatigue during arm tasks
        important to daily living. Two mechanisms have been suggested underlying this:
        neuromechanical dysfunction of the respiratory muscles (diaphragm and accessory respiratory
        muscles) (thoracoabdominal asynchrony) and changes in lung volume during activities involving
        the upper extremities. During arm exercise, accessory respiratory muscles are used for arm
        function and cannot contribute to respiration. This increases the respiratory load of the
        mechanically disadvantaged diaphragm and results in thoracoabdominal synchrony and severe
        dyspnea. Since the muscles that move the arm and stabilize the trunk are attached to the rib
        cage, they increase the resistance of the chest wall and limit the ability to increase tidal
        volume during arm activities. These disturbances in ventilatory mechanics result in
        termination of arm exercise in patients with COPD at lower workloads compared to healthy
        subjects.
  
        The '6 Minute Pegboard and Ring Test-6PRT' is a valid and reliable, useful, practical and
        easy-to-apply test that evaluates unassisted arm endurance in COPD patients, asthmatic
        patients and healthy individuals. For the test, patients are asked to carry as many rings as
        possible within 6 minutes and the number of rings carried during 6 minutes is recorded as a
        score.
  
        In a study conducted in patients with mild to very severe COPD, a positive correlation was
        shown between the 6PRT score and the activity counts evaluated by accelerometer. In addition,
        it was determined that the 6PRT score showed a clear relationship with the upper extremity
        ADL, and it was concluded that the 6PRT test could be used as an appropriate test for
        estimating and demonstrating the improvement of ADL in pulmonary rehabilitation programs.
  
        Studies have recently been published showing reference values for 6PBRT in Brazilian and
        Indian populations. In one of the results, a correlation was found between the score value
        and age, showing that younger individuals were able to move more rings than the older group.
        In addition, a weak correlation was found between the test score and the level of physical
        activity. Normative values and reference range for 6PBRT are not available for various
        ethnicities, including the Turkish adults. Therefore, in this study; It is aimed to find
        reference values for the 6PBRT test in the Turkish adults.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Unsupported Arm Exercise Capacity and Arm Function/Endurance
  time frame: 50 minute
  description: It will be evaluated with the '6 minute Pegboard and Ring Test-6PRT'. During the test, the patient is asked to sit in front of a pegboard and move as many rings as possible from the two lower holes to the two upper holes, using both hands simultaneously, for 6 minutes. Before the test, participants get used to the test by wearing a few rings. Standardized encouragement is given every minute during the test. The number of rings carried during 6 minutes constitutes the final score. Before and after the test, heart rate and oxygen saturation with pulse oximetry, dyspnea, general fatigue and arm fatigue perception with modified Borg scale are questioned. For the validity of the test, the test will be repeated in the same patient with one week intervals under the same conditions.
  measure: Arm length of both sides and the arm and forearm circumferences of the dominant arm
  time frame: 1 day
  description: The measurement was done with non-stretch tape
  measure: Physical Activity Level
  time frame: 1 day
  description: It was evaluated with the Human Activity Profile.The level of physical activity of individuals is classifi ed by calculating the adjusted activity score (AAS), resulting in their being classifi ed as inactive or debilitated (AAS < 53 points), moderately active (AAS between 53 and 74 points), or active (AAS > 74 points)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ebru Calik Kutukcu, Assoc.Prof.
  role: Principal Investigator
  affiliation: Hacettepe University
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ankara City Hospital Bilkent
  investigator full name: Ulaş Ar
  investigator title: Investigator
  sharing ipd: No