<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/NCT03840941</url>
  </required_header>
  <id_info>
    <org_study_id>GO 18/83-22</org_study_id>
    <nct_id>NCT03840941</nct_id>
  </id_info>
  <brief_title>The Effect of Frailty on Balance, Activities of Daily, and Exercise Capacity in COPD</brief_title>
  <official_title>The Effect Of Frailty Level On Balance, Cognition And Activities Of Daily Living In COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe 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 investigators aim to demonstrate whether balance, cognition and activities of daily&#xD;
      living have changed in COPD patients with and without frailty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COPD is a common, preventable and treatable disease characterized by progressive respiratory&#xD;
      symptoms and airflow limitation. Frailty defines a clinical syndrome characterized by&#xD;
      multiple system effects, leading to decreased functional reserve and increased sensitivity to&#xD;
      dependence or mortality following minor stress events. Inflammation, lack of physical&#xD;
      activity, reduced exercise efficiency and maximum oxygen uptake may contribute to the&#xD;
      development of frailty in patients with COPD. Balance, cognition and activities of daily&#xD;
      living are associated with COPD.&#xD;
&#xD;
      This study will evaluate the effect of frailty on balance, cognition and activities of daily&#xD;
      living in patients with COPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of The Frailty Will Be evaluated Using The Frailty Criteria by Fried</measure>
    <time_frame>1st Day</time_frame>
    <description>Frailty will be identified by the presence of three or more of the following criteria unintentional weight loss (10 Ibs in past year), weakness (grip strength), self-reported exhaustion, slow walking speed and low physical activity. Patients with three or more of the criteria present were classified as frail.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance Assessment Using Functional Reach Test</measure>
    <time_frame>1st Day</time_frame>
    <description>The Functional Reach Test measures how far patient can reach forward from a normal relaxed stance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognition Using MoCA-Test</measure>
    <time_frame>1st Day</time_frame>
    <description>Cognitive function will be evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perform activities of daily living (ADL) will be evaluated using the Glittre ADL-test</measure>
    <time_frame>1st Day</time_frame>
    <description>Glittre ADL-test was designed specifically to assess the functional limitation in patients with COPD. Glittre ADL-test time will be considered the main outcome variable, and will be recorded in minutes (metric).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise Capacity Using 6-Minute Walk Test</measure>
    <time_frame>1st Day</time_frame>
    <description>The standard protocol of the test is applied in a 30-meter continuous corridor. Standard instructions are given during testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-Related Quality of Life Assessment</measure>
    <time_frame>1st Day</time_frame>
    <description>COPD evaluation test (CAT) was developed to help assess health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Muscle Strength Assessment</measure>
    <time_frame>1st Day</time_frame>
    <description>Respiratory muscle strength will be evaluated by non-invasive methods by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shortness of Breath Assessment</measure>
    <time_frame>1st Day</time_frame>
    <description>Modified Medical Research Council (mMRC) dyspnea scale will be used to determine the shortness of breath severity.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>COPD</condition>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Frail patients with COPD</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-frail patients with COPD</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who are diagnosed with COPD at Hacettepe University and who are referred to the&#xD;
        Cardiopulmonary Rehabilitation Unit for physiotherapy also who are willing to participate&#xD;
        in the study will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients who have been clinically stable for the last four weeks and who have not&#xD;
             undergone drug change for the last four weeks&#xD;
&#xD;
          -  Being 55 years of age or older&#xD;
&#xD;
          -  Accepted to participate in the study (Able and wililing to complete the informed&#xD;
             consent process)&#xD;
&#xD;
          -  Co-operate&#xD;
&#xD;
          -  Patients with COPD who are ambulant without support or an assistive device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological, cardiac or orthopedic diseases&#xD;
&#xD;
          -  Other chronic diseases that may affect balance and walking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deniz Inal-Ince, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Deniz Inal-Ince, PhD</last_name>
    <phone>+903123051577</phone>
    <phone_ext>148</phone_ext>
    <email>dinalince@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sezen Ulusoy, PT</last_name>
    <phone>+903123051577</phone>
    <phone_ext>148</phone_ext>
    <email>sezenulusoy@hacettepe.edu.tr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <state>Sihhiye</state>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sezen Ulusoy, Researcher</last_name>
      <phone>+903123051576</phone>
      <email>s.sezenulusoy@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Deniz Inal-Ince, PhD, PT</last_name>
      <phone>+903123051577</phone>
      <phone_ext>148</phone_ext>
      <email>dinalince@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Deniz Inal-Ince</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Frailty</keyword>
  <keyword>Balance</keyword>
  <keyword>Cognition</keyword>
  <keyword>Activities of Daily Living</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <!-- 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/NCT03840941
org study id: GO 18/83-22
nct id: NCT03840941
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim to demonstrate whether balance, cognition and activities of daily
      living have changed in COPD patients with and without frailty.
COPD is a common, preventable and treatable disease characterized by progressive respiratory
      symptoms and airflow limitation. Frailty defines a clinical syndrome characterized by
      multiple system effects, leading to decreased functional reserve and increased sensitivity to
      dependence or mortality following minor stress events. Inflammation, lack of physical
      activity, reduced exercise efficiency and maximum oxygen uptake may contribute to the
      development of frailty in patients with COPD. Balance, cognition and activities of daily
      living are associated with COPD.

      This study will evaluate the effect of frailty on balance, cognition and activities of daily
      living in patients with COPD.
observational model: Case-Control
time perspective: Prospective
measure: Presence of The Frailty Will Be evaluated Using The Frailty Criteria by Fried
time frame: 1st Day
description: Frailty will be identified by the presence of three or more of the following criteria unintentional weight loss (10 Ibs in past year), weakness (grip strength), self-reported exhaustion, slow walking speed and low physical activity. Patients with three or more of the criteria present were classified as frail.
measure: Balance Assessment Using Functional Reach Test
time frame: 1st Day
description: The Functional Reach Test measures how far patient can reach forward from a normal relaxed stance.
measure: Cognition Using MoCA-Test
time frame: 1st Day
description: Cognitive function will be evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool.
measure: Perform activities of daily living (ADL) will be evaluated using the Glittre ADL-test
time frame: 1st Day
description: Glittre ADL-test was designed specifically to assess the functional limitation in patients with COPD. Glittre ADL-test time will be considered the main outcome variable, and will be recorded in minutes (metric).
measure: Exercise Capacity Using 6-Minute Walk Test
time frame: 1st Day
description: The standard protocol of the test is applied in a 30-meter continuous corridor. Standard instructions are given during testing.
measure: Disease-Related Quality of Life Assessment
time frame: 1st Day
description: COPD evaluation test (CAT) was developed to help assess health status.
measure: Respiratory Muscle Strength Assessment
time frame: 1st Day
description: Respiratory muscle strength will be evaluated by non-invasive methods by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
measure: Shortness of Breath Assessment
time frame: 1st Day
description: Modified Medical Research Council (mMRC) dyspnea scale will be used to determine the shortness of breath severity.
arm group label: Frail patients with COPD
description: No intervention
arm group label: Non-frail patients with COPD
description: No intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: No
last name: Deniz Inal-Ince, PhD
role: Principal Investigator
affiliation: Hacettepe University
last name: Deniz Inal-Ince, PhD
phone: +903123051577
phone ext: 148
email: dinalince@yahoo.com
last name: Sezen Ulusoy, PT
phone: +903123051577
phone ext: 148
email: sezenulusoy@hacettepe.edu.tr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Deniz Inal-Ince
investigator title: Prof. Dr.
mesh term: Frailty