<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/NCT04431921</url>
  </required_header>
  <id_info>
    <org_study_id>GO17/555</org_study_id>
    <nct_id>NCT04431921</nct_id>
  </id_info>
  <brief_title>Assessment of Functional Capacity, Pain, Cognitive and Respiratory Functions in Lung Cancer Survivors</brief_title>
  <official_title>Assessment of Functional Capacity, Pain, Cognitive and Respiratory Functions in Lung Cancer Survivors</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>
      Serious side effects occurs with disease and treatments in survival after lung cancer. For&#xD;
      this reason, functional capacity, cognitive status, pain perception and respiratory functions&#xD;
      may be affected in lung cancer. The purpose of this study was to evaluate respiratory&#xD;
      function, respiratory muscle strength and endurance, functional capacity, pain, cognitive&#xD;
      status level, and physical activity in lung cancer patients and compare with the findings of&#xD;
      healthy subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was participated lung cancer patients survivors. Patients' pulmonary function&#xD;
      test, functional capacity, respiratory muscle strength and endurance, pain and cognitive&#xD;
      status was assessed and recorded.&#xD;
&#xD;
      Pulmonary function testing (PFT), mouth pressure measurement (MIP- maximal inspiratory&#xD;
      pressure and MEP- maximal expiratory pressure), respiratory muscle endurance test, six minute&#xD;
      walk test (6MWT) and pain threshold and tolerance test were used. In addition to&#xD;
      physiological measurements, the Montreal Cognitive Assessment (MoCA) scale was used to&#xD;
      evaluate cognitive status, the International Physical Activity Questionnaire (IPAQ) was used&#xD;
      to determine the level of physical activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</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>Functional capacity</measure>
    <time_frame>15 minutes</time_frame>
    <description>Six minute walk test: Distance walked in six minute was recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory muscle strength assessment</measure>
    <time_frame>10 minutes</time_frame>
    <description>Respiratory muscle strength was evaluated by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory muscle endurance</measure>
    <time_frame>10 minutes</time_frame>
    <description>Pressure time unit: A constant load test was used to evaluate respiratory muscle endurance. Using a PowerBreathe device (HaB International Ltd., Southam, UK), the participants were asked to breathe maintaining a constant threshold (60% of MIP) until task failure, and the test duration was recorded. Results were obtained by multiplying the set pressure by the test duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary functions test</measure>
    <time_frame>15 minutes</time_frame>
    <description>pulmonary functions assessment via spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition using MoCA-Test</measure>
    <time_frame>10 minutes</time_frame>
    <description>Cognitive function was evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain threshold assessment</measure>
    <time_frame>15 minute</time_frame>
    <description>Pressure pain threshold was evaluated via algometer. The pressure at which the individual first reported pain was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain tolerance assessment</measure>
    <time_frame>15 minute</time_frame>
    <description>Pressure pain tolerance test was evaluated via algometer.The pressure at which the individual last pressure point at which they could endure the pain was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>5 minutes</time_frame>
    <description>International Physical Activity Questionnaire-Short Form</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Lung Neoplasm</condition>
  <condition>Survivorship</condition>
  <arm_group>
    <arm_group_label>Lung cancer patients</arm_group_label>
    <description>Lung cancer survivors who had stable conditions and routine follow-up at Hacettepe University Oncology Hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>No health problems related or affect outcome measure parameters examined in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Functional capacity</intervention_name>
    <description>Six minute walk test used assessment of functional capacity. For respiratory function mouth pressures, for cognitive functions MoCA scale and for pain assessment pain threshold and tolerance test assessed.</description>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Lung cancer patients</arm_group_label>
    <other_name>Exercise capacity</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Lung cancer patients -&gt; patients who were not under active cancer treatments Healthy -&gt; No&#xD;
        lung disease and systemic disease that affected outcome measure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cooperation&#xD;
&#xD;
          -  lung cancer patients who had a stable condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active cancer treatments&#xD;
&#xD;
          -  Brain metastasis story&#xD;
&#xD;
          -  Any orthopedic disease impairs walking, balance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naciye Vardar-Yagli, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Deniz Inal-Ince, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Melda Saglam, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ebru Calik-Kütükcü, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hulya Arikan, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Saadettin Kilickap, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Kübra Kılıç</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Respiratory muscles</keyword>
  <keyword>Pain</keyword>
  <keyword>Cognitive dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04431921
org study id: GO17/555
nct id: NCT04431921
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Serious side effects occurs with disease and treatments in survival after lung cancer. For
      this reason, functional capacity, cognitive status, pain perception and respiratory functions
      may be affected in lung cancer. The purpose of this study was to evaluate respiratory
      function, respiratory muscle strength and endurance, functional capacity, pain, cognitive
      status level, and physical activity in lung cancer patients and compare with the findings of
      healthy subjects
This study was participated lung cancer patients survivors. Patients' pulmonary function
      test, functional capacity, respiratory muscle strength and endurance, pain and cognitive
      status was assessed and recorded.

      Pulmonary function testing (PFT), mouth pressure measurement (MIP- maximal inspiratory
      pressure and MEP- maximal expiratory pressure), respiratory muscle endurance test, six minute
      walk test (6MWT) and pain threshold and tolerance test were used. In addition to
      physiological measurements, the Montreal Cognitive Assessment (MoCA) scale was used to
      evaluate cognitive status, the International Physical Activity Questionnaire (IPAQ) was used
      to determine the level of physical activity.
observational model: Case-Control
time perspective: Prospective
measure: Functional capacity
time frame: 15 minutes
description: Six minute walk test: Distance walked in six minute was recorded
measure: Respiratory muscle strength assessment
time frame: 10 minutes
description: Respiratory muscle strength was evaluated by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
measure: Respiratory muscle endurance
time frame: 10 minutes
description: Pressure time unit: A constant load test was used to evaluate respiratory muscle endurance. Using a PowerBreathe device (HaB International Ltd., Southam, UK), the participants were asked to breathe maintaining a constant threshold (60% of MIP) until task failure, and the test duration was recorded. Results were obtained by multiplying the set pressure by the test duration
measure: Pulmonary functions test
time frame: 15 minutes
description: pulmonary functions assessment via spirometry
measure: Cognition using MoCA-Test
time frame: 10 minutes
description: Cognitive function was evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool. Higher scores mean a better outcome.
measure: Pressure pain threshold assessment
time frame: 15 minute
description: Pressure pain threshold was evaluated via algometer. The pressure at which the individual first reported pain was recorded.
measure: Pressure pain tolerance assessment
time frame: 15 minute
description: Pressure pain tolerance test was evaluated via algometer.The pressure at which the individual last pressure point at which they could endure the pain was recorded.
measure: Physical activity level
time frame: 5 minutes
description: International Physical Activity Questionnaire-Short Form
arm group label: Lung cancer patients
description: Lung cancer survivors who had stable conditions and routine follow-up at Hacettepe University Oncology Hospital
arm group label: Healthy subjects
description: No health problems related or affect outcome measure parameters examined in this study.
intervention type: Diagnostic Test
intervention name: Functional capacity
description: Six minute walk test used assessment of functional capacity. For respiratory function mouth pressures, for cognitive functions MoCA scale and for pain assessment pain threshold and tolerance test assessed.
arm group label: Healthy subjects
arm group label: Lung cancer patients
other name: Exercise capacity
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naciye Vardar-Yagli, PhD
role: Study Director
affiliation: Hacettepe University
last name: Deniz Inal-Ince, Professor
role: Study Chair
affiliation: Hacettepe University
last name: Melda Saglam, PhD
role: Study Chair
affiliation: Hacettepe University
last name: Ebru Calik-Kütükcü, PhD
role: Study Chair
affiliation: Hacettepe University
last name: Hulya Arikan, Professor
role: Study Chair
affiliation: Hacettepe University
last name: Saadettin Kilickap, Professor
role: Study Chair
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Kübra Kılıç
investigator title: Physiotherapist
mesh term: Lung Neoplasms
sharing ipd: Undecided