<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/NCT01682447</url>
  </required_header>
  <id_info>
    <org_study_id>NL33713.008.10</org_study_id>
    <nct_id>NCT01682447</nct_id>
  </id_info>
  <brief_title>Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD</brief_title>
  <official_title>Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tilburg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Revant Schoondonck Center for Pulmonary Rehabilitation Breda</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Revant Innovation foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fonds NutsOhra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tilburg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to investigate whether a 12-week, fulltime pulmonary&#xD;
      rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life&#xD;
      in patients with Chronic Obstructive Pulmonary Disease (COPD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Objective Cognitive functioning</measure>
    <time_frame>In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.</time_frame>
    <description>CNS-Vital Signs, computerized neuropsychological assessment WMS - Verbal Paired Associates Direct Recall Word fluency-category (GIT): animals &amp; profession Letter fluency: D-A-T Purdue Pegboard</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mood and Anxiety</measure>
    <time_frame>In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS)&#xD;
Symptom Checklist 90 - Revised (SCL-90-R), subscales Anxiety, Depression, Agoraphobia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.</time_frame>
    <description>Saint George Respiratory Questionnaire (SGRQ)&#xD;
SF-36 Health Survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in 6 Minute Walking distance Test(6-MWT)</measure>
    <time_frame>In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.</time_frame>
    <description>6 Minute Walking distance Test (6-MWT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Subjective Cognitive Functioning</measure>
    <time_frame>In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.</time_frame>
    <description>Cognitive Failures Questionnaire (CFQ)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to pulmonary rehabilitation</measure>
    <time_frame>These data are collected during the total period of pulmonary rehabilitation, which has a time frame of 12 weeks.</time_frame>
    <description>Percentage of attendance of treatment session is collected from patients medical records.&#xD;
Adherence to pulmonary rehabilitation is specified as the percentage of the prescribed treatment sessions that patients actually attend. Adherence is further specified in the following categories: disease, motivation, other.&#xD;
We use this measure to explore the predictors (e.g., age, education, cognitive functioning) of adherence to pulmonary rehabilitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fatigue</measure>
    <time_frame>In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.</time_frame>
    <description>Chronic Respiratory Questionnaire (CRQ), subscale fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dropout from pulmonary rehabilitation</measure>
    <time_frame>From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.</time_frame>
    <description>Dropout can be specified as the percentage of patients who, though eligible, do not start pulmonary rehabilitation or patients who do not finish pulmonary rehabilitation. Dropout is further specified in the following categories: death, disease, motivation, practical (e.g. move).&#xD;
We use this measure to explore the predictors (e.g., age, education, cognitive functioning) of dropout from pulmonary rehabilitation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">261</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease COPD</condition>
  <arm_group>
    <arm_group_label>Extensive Pulmonary Rehabilitation (ERP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group are measured on primary and secondary outcome measures before and after a 12 week extensive pulmonary rehabilitation program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting List Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the waiting list control group are measured on primary and secondary outcome measures before and after waiting time for the extensive pulmonary rehabilitation program and start with this program after the second moment of measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Extensive Pulmonary Rehabilitation Program</intervention_name>
    <description>Fulltime pulmonary rehabilitation program. Duration: 12 weeks</description>
    <arm_group_label>Extensive Pulmonary Rehabilitation (ERP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD&#xD;
&#xD;
          -  Referral to the Extensive Pulmonary Rehabilitation Program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unfinished primary school&#xD;
&#xD;
          -  Referral to the Compact Pulmonary Rehabilitation Program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margriet M. Sitskoorn, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tilburg University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jan-Willem Meijer, MD., PhD.</last_name>
    <role>Study Chair</role>
    <affiliation>Revant Revalidatiecentrum Breda</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dirk Van Ranst, MD.</last_name>
    <role>Study Chair</role>
    <affiliation>Revant Revalidatiecentrum Breda</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlijn A.M. Campman, MSc.</last_name>
    <role>Study Chair</role>
    <affiliation>Tilburg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Revant Schoondonck Center for Pulmonary Rehabilitation</name>
      <address>
        <city>Breda</city>
        <zip>4817 JW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>October 27, 2017</last_update_submitted>
  <last_update_submitted_qc>October 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tilburg University</investigator_affiliation>
    <investigator_full_name>Margriet M. Sitskoorn</investigator_full_name>
    <investigator_title>Professor, PhD</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Cognitive Dysfunction</keyword>
  <keyword>Pulmonary Rehabilitation</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Cognitive rehabilitation</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>
  <!-- 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/NCT01682447
org study id: NL33713.008.10
nct id: NCT01682447
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this project is to investigate whether a 12-week, fulltime pulmonary
      rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life
      in patients with Chronic Obstructive Pulmonary Disease (COPD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change in Objective Cognitive functioning
time frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
description: CNS-Vital Signs, computerized neuropsychological assessment WMS - Verbal Paired Associates Direct Recall Word fluency-category (GIT): animals & profession Letter fluency: D-A-T Purdue Pegboard
measure: Change in Mood and Anxiety
time frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
description: Hospital Anxiety and Depression Scale (HADS)
Symptom Checklist 90 - Revised (SCL-90-R), subscales Anxiety, Depression, Agoraphobia
measure: Change in Quality of Life
time frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
description: Saint George Respiratory Questionnaire (SGRQ)
SF-36 Health Survey
measure: Change in 6 Minute Walking distance Test(6-MWT)
time frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
description: 6 Minute Walking distance Test (6-MWT)
measure: Change in Subjective Cognitive Functioning
time frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
description: Cognitive Failures Questionnaire (CFQ)
measure: Adherence to pulmonary rehabilitation
time frame: These data are collected during the total period of pulmonary rehabilitation, which has a time frame of 12 weeks.
description: Percentage of attendance of treatment session is collected from patients medical records.
Adherence to pulmonary rehabilitation is specified as the percentage of the prescribed treatment sessions that patients actually attend. Adherence is further specified in the following categories: disease, motivation, other.
We use this measure to explore the predictors (e.g., age, education, cognitive functioning) of adherence to pulmonary rehabilitation.
measure: Change in Fatigue
time frame: In the experimental group, this measure is assessed in the first and last week of rehabilitation with an average time frame of 11 weeks. In the Control group, this measure is assessed before and after waiting time with an average time frame of 5 weeks.
description: Chronic Respiratory Questionnaire (CRQ), subscale fatigue
measure: Dropout from pulmonary rehabilitation
time frame: From the moment of randomization untill the moment of dropout from pulmonary rehabilitation, assessed up to 1 year after randomization.
description: Dropout can be specified as the percentage of patients who, though eligible, do not start pulmonary rehabilitation or patients who do not finish pulmonary rehabilitation. Dropout is further specified in the following categories: death, disease, motivation, practical (e.g. move).
We use this measure to explore the predictors (e.g., age, education, cognitive functioning) of dropout from pulmonary rehabilitation.
arm group label: Extensive Pulmonary Rehabilitation (ERP)
arm group type: Experimental
description: Participants in this group are measured on primary and secondary outcome measures before and after a 12 week extensive pulmonary rehabilitation program.
arm group label: Waiting List Control group
arm group type: No Intervention
description: Participants in the waiting list control group are measured on primary and secondary outcome measures before and after waiting time for the extensive pulmonary rehabilitation program and start with this program after the second moment of measurement.
intervention type: Other
intervention name: Extensive Pulmonary Rehabilitation Program
description: Fulltime pulmonary rehabilitation program. Duration: 12 weeks
arm group label: Extensive Pulmonary Rehabilitation (ERP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Margriet M. Sitskoorn, PhD.
role: Principal Investigator
affiliation: Tilburg University
last name: Jan-Willem Meijer, MD., PhD.
role: Study Chair
affiliation: Revant Revalidatiecentrum Breda
last name: Dirk Van Ranst, MD.
role: Study Chair
affiliation: Revant Revalidatiecentrum Breda
last name: Carlijn A.M. Campman, MSc.
role: Study Chair
affiliation: Tilburg University
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Tilburg University
investigator full name: Margriet M. Sitskoorn
investigator title: Professor, PhD
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive