<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/NCT02979379</url>
  </required_header>
  <id_info>
    <org_study_id>16-001-WP</org_study_id>
    <nct_id>NCT02979379</nct_id>
  </id_info>
  <brief_title>Pain in Individuals With COPD During Pulmonary Rehabilitation</brief_title>
  <official_title>Does Pulmonary Rehabilitation Aggravate or Relieve Symptoms of Pain in Individuals With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Park Healthcare Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Park Healthcare Centre</source>
  <brief_summary>
    <textblock>
      This study is aimed at determining the role of pain in individuals with chronic obstructive&#xD;
      pulmonary disease (COPD) who are enrolled in a pulmonary rehabilitation (PR) program. It is&#xD;
      not known whether pain interferes with an individuals performance in PR, or whether PR&#xD;
      aggravates or relieves pain. Individuals with COPD who report chronic pain and those without&#xD;
      pain will be enrolled in the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is a systemic disease associated with dyspnea,&#xD;
      fatigue, and poor health-related quality of life. COPD is further complicated by the presence&#xD;
      of pain which may be attributed to common comorbidities such as musculoskeletal conditions&#xD;
      (osteoarthritis, osteoporosis), cardiac disease or diabetes. Pulmonary rehabilitation (PR) is&#xD;
      the cornerstone of treatment for COPD however the impact of pain on PR has not been explored.&#xD;
      It is unclear whether those experiencing chronic pain achieve a similar, lesser or greater&#xD;
      degree of benefit compared to those without pain, or whether exercise training exacerbates&#xD;
      symptoms. Gaining a greater understanding of the effects of an outpatient PR program on pain&#xD;
      will provide direction into future specific treatment options which may necessary for&#xD;
      managing chronic pain as part of PR.&#xD;
&#xD;
      Individuals with COPD who are beginning an out-patient PR program will be enrolled in the&#xD;
      study. Those who report the presence of chronic pain will be classed as the pain group; those&#xD;
      who report the absence of chronic pain will be classed as the comparator group. All&#xD;
      participants will complete a 6-minute walk test and a Chronic Respiratory Disease&#xD;
      Questionnaire (CRDQ) at the beginning of the PR program. These measures will be repeated at&#xD;
      the end of the 8-week PR program for all participants. All participants will be asked to&#xD;
      report their level of pain using a visual analogue scale every two weeks during the PR&#xD;
      program.&#xD;
&#xD;
      Participants reporting chronic pain will also complete a series of questionnaires regarding&#xD;
      their pain and coping strategies. These include; the Brief Pain Inventory (BPI), Coping&#xD;
      Strategies Questionnaire (CSQ), Fear Avoidance Behavior Questionnaire (FABQ), Hospital&#xD;
      Anxiety and Depression Scale (HADS) and Centre for Epidemiological Studies for Depression&#xD;
      Survey (CES-D).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">March 3, 2020</completion_date>
  <primary_completion_date type="Actual">December 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>Change in qualities of pain (intensity, location, interference)</measure>
    <time_frame>Change from Baseline to end of 8-Week PR program</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in coping ability specific to pain and fear avoidance</measure>
    <time_frame>Change from Baseline to end of 8-Week PR program</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between depression and other psychological factors influencing chronic pain, including coping ability and fear avoidance behaviour</measure>
    <time_frame>Change from Baseline to end of 8-Week PR program</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional exercise capacity and health related quality of life between those with chronic pain and those without pain</measure>
    <time_frame>Change from Baseline to end of 8-Week PR program</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">68</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Pain</arm_group_label>
    <description>Individuals with COPD who experience chronic pain (episodes of daily pain for a duration greater than three months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Pain</arm_group_label>
    <description>Individuals with COPD who do not experience pain on a regular basis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain</intervention_name>
    <arm_group_label>No Pain</arm_group_label>
    <arm_group_label>Pain</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with moderate to severe COPD enrolled in an out-patient pulmonary rehabilitation&#xD;
        program&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals with moderate to severe COPD based on international (GOLD) criteria&#xD;
&#xD;
          -  clinically stable&#xD;
&#xD;
          -  no history of acute exacerbation in the past 6 weeks&#xD;
&#xD;
          -  able to provide their own informed consent&#xD;
&#xD;
          -  referred to out-patient pulmonary rehabilitation at West Park Healthcare Centre&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  primary diagnosis other than COPD&#xD;
&#xD;
          -  known cognitive impairment that would interfere with completing surveys&#xD;
&#xD;
          -  cardiac, neurological or orthopedic conditions which prevent the ability to undertake&#xD;
             exercise safely&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>West Park Healthcare Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6M 2J5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>April 29, 2022</last_update_submitted>
  <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Park Healthcare Centre</investigator_affiliation>
    <investigator_full_name>Roger Goldstein</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02979379
org study id: 16-001-WP
nct id: NCT02979379
lead sponsor: 
This study is aimed at determining the role of pain in individuals with chronic obstructive
      pulmonary disease (COPD) who are enrolled in a pulmonary rehabilitation (PR) program. It is
      not known whether pain interferes with an individuals performance in PR, or whether PR
      aggravates or relieves pain. Individuals with COPD who report chronic pain and those without
      pain will be enrolled in the study.
Chronic obstructive pulmonary disease (COPD) is a systemic disease associated with dyspnea,
      fatigue, and poor health-related quality of life. COPD is further complicated by the presence
      of pain which may be attributed to common comorbidities such as musculoskeletal conditions
      (osteoarthritis, osteoporosis), cardiac disease or diabetes. Pulmonary rehabilitation (PR) is
      the cornerstone of treatment for COPD however the impact of pain on PR has not been explored.
      It is unclear whether those experiencing chronic pain achieve a similar, lesser or greater
      degree of benefit compared to those without pain, or whether exercise training exacerbates
      symptoms. Gaining a greater understanding of the effects of an outpatient PR program on pain
      will provide direction into future specific treatment options which may necessary for
      managing chronic pain as part of PR.

      Individuals with COPD who are beginning an out-patient PR program will be enrolled in the
      study. Those who report the presence of chronic pain will be classed as the pain group; those
      who report the absence of chronic pain will be classed as the comparator group. All
      participants will complete a 6-minute walk test and a Chronic Respiratory Disease
      Questionnaire (CRDQ) at the beginning of the PR program. These measures will be repeated at
      the end of the 8-week PR program for all participants. All participants will be asked to
      report their level of pain using a visual analogue scale every two weeks during the PR
      program.

      Participants reporting chronic pain will also complete a series of questionnaires regarding
      their pain and coping strategies. These include; the Brief Pain Inventory (BPI), Coping
      Strategies Questionnaire (CSQ), Fear Avoidance Behavior Questionnaire (FABQ), Hospital
      Anxiety and Depression Scale (HADS) and Centre for Epidemiological Studies for Depression
      Survey (CES-D).
observational model: Case-Control
time perspective: Prospective
measure: Change in qualities of pain (intensity, location, interference)
time frame: Change from Baseline to end of 8-Week PR program
measure: Change in coping ability specific to pain and fear avoidance
time frame: Change from Baseline to end of 8-Week PR program
measure: Relationship between depression and other psychological factors influencing chronic pain, including coping ability and fear avoidance behaviour
time frame: Change from Baseline to end of 8-Week PR program
measure: Change in functional exercise capacity and health related quality of life between those with chronic pain and those without pain
time frame: Change from Baseline to end of 8-Week PR program
arm group label: Pain
description: Individuals with COPD who experience chronic pain (episodes of daily pain for a duration greater than three months)
arm group label: No Pain
description: Individuals with COPD who do not experience pain on a regular basis.
intervention type: Other
intervention name: Pain
arm group label: No Pain
arm group label: Pain
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: West Park Healthcare Centre
investigator full name: Roger Goldstein
investigator title: MD
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive