<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/NCT02987439</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2013-143</org_study_id>
    <nct_id>NCT02987439</nct_id>
  </id_info>
  <brief_title>COPD-EXA-REHAB. Early Pulmonary Rehabilitation of Patients With Acute Exacerbation of COPD</brief_title>
  <official_title>COPD-EXA-REHAB. Early Pulmonary Rehabilitation of Patients With Acute Exacerbation of COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: In a randomized controlled trial we will assess the effect of early pulmonary&#xD;
      rehabilitation in patient with an acute exacerbation of chronic obstructive lung disease&#xD;
      (AECOPD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Pulmonary rehabilitation is a key element in treatment of stable COPD. A Cochrane review from&#xD;
      2011 showed that early pulmonary rehabilitation for COPD exacerbation 6-10 days after&#xD;
      discharge, or during prolonged hospitalization significantly reduced mortality and&#xD;
      hospitalizations without serious side effects. It consist of 9 small studies and larger RCT&#xD;
      studies is required to establish the effect of early pulmonary rehabilitation.&#xD;
&#xD;
      AIM: The aim of the study is to investigate whether early pulmonary rehabilitation can reduce&#xD;
      mortality og hospitalization in patients with acute exacerbation of COPD. Secondary increase&#xD;
      exercise capacity, reduce symptoms and improve quality of life.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Design: The study is a single center randomized, controlled, open label trial, with an&#xD;
      intervention group and a control group. The patients are randomized to either a prespecified&#xD;
      rehabilitation program, which is standardized to patients with COPD, or usual care. The&#xD;
      patients' data are being recorded at baseline and visits at 2 and 6 months: Lung function&#xD;
      (FEV1, FVC), CO in exhaled air, O2 saturation in the blood (and possibly O2 supplement),&#xD;
      Heart Rate, Dyspnoea (Borg scale and Medical Research Council (MRC scale)), Quality of life&#xD;
      (CAT), Walk Test (ISWT and ESWT), Daily medication, Outdoor activity. Information on&#xD;
      mortality, hospital admissions, emergency room visits after 6 and 12 months is obtained from&#xD;
      relevant databases.&#xD;
&#xD;
      Population: Patients Hospitalized with an exacerbation of COPD to the department of&#xD;
      respiratory medicine at Gentofte Hospital. The inclusion criteria are: A diagnose of COPD,&#xD;
      Age &gt;18, expected discharge to own homes, can walk 10 meters independently (with or without a&#xD;
      walking aid). Exclusion criteria are: Life expectancy &lt;6 months due to another illness&#xD;
      (cancer, severe heart disease, etc.), difficulties in understanding and speaking Danish (e.g.&#xD;
      due to dementia), place of residence outside Gentofte Hospital admission area.&#xD;
&#xD;
      Randomization: A total of 150 COPD patients will be included. The participants are randomized&#xD;
      to early rehabilitation or usual care in a 1:1 ratio, using a computer-generated&#xD;
      block-randomization for each center. The participant is presented with a sealed envelope&#xD;
      containing a piece of paper with either &quot;A&quot; (= REHAB) or &quot;B&quot; (= usual care). The&#xD;
      randomization list is stored at Gentofte Hospital in a sealed envelope.&#xD;
&#xD;
      A participant who is readmitted will not be re-randomized.&#xD;
&#xD;
      Patients arre introduced to an acute telephone hotline, operated by a nurse.&#xD;
&#xD;
      The patients in the intervention group will during Hospitalization begin the rehabilitation&#xD;
      program. The program consist of exercise training, breathing techniques and education. Before&#xD;
      discharge the patients will be assessed to either A: outpatient rehabilitation in hospital or&#xD;
      community clinic or B: Rehabilitation in their own homes twice weekly in 7 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite outcome of 1 year mortality or hospital readmission</measure>
    <time_frame>12 months</time_frame>
    <description>It is all cause mortality in 12 months follow-up period.. Readmission is the proportion of patients with at least 1 hospital readmission in 12 months follow-up period. Intention-to-treat analysis.Secondarily per-protocol analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality and time to death</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause hospital readmission and time to readmission</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of patients with at least 1 hospital readmission of any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmission by respiratory cause</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by COPD Assessment TEST (CAT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by Medical Respiratory Council (MRC) dyspnea scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise performance</measure>
    <time_frame>6 months</time_frame>
    <description>Composite measure by Incremental Shuttle Walk Test (ISWT) and Endurance Shuttle Walk Test (ESWT)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Chronic Obstructive Lung Disease</condition>
  <arm_group>
    <arm_group_label>Standard care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard medical treatment for the exacerbation of COPD&#xD;
Standard medical treatment of COPD according to GOLD&#xD;
A visit by a pulmonary nurse at the patients own home 3-5 days after discharge. Lung function and smoking history is recorded. Correct use of inhaler is instructed.&#xD;
Visit in the outpatient clinic within the next 2-6 months after discharge as follow-up&#xD;
In the outpatient clinic they will receive an offer of pulmonary rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rehabilitation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group will begin pulmonary rehabilitation during hospital admission. Afterwards a rehabilitation program twice weekly for 7 weeks.&#xD;
Beside rehabilitation they will receive same treatment as the standard care group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pulmonary rehabilitation</intervention_name>
    <description>The intervention is pulmonary rehabilitation</description>
    <arm_group_label>Rehabilitation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to hospital with acute exacerbation of COPD to Department&#xD;
             Respiratory Medicine, Gentofte Hospital&#xD;
&#xD;
          -  Verified diagnosis of COPD FEV1/FVC &lt;70 % in stable phase.&#xD;
&#xD;
          -  Expected discharge to their own home.&#xD;
&#xD;
          -  Minimal of 10 meters walking distance independently&#xD;
&#xD;
          -  Oral and written consent&#xD;
&#xD;
          -  Age &gt; 18 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt;6 months due to another illness (cancer, severe heart disease, etc.)&#xD;
&#xD;
          -  Difficulties in understanding and speaking Danish (eg. due to dementia)&#xD;
&#xD;
          -  Place of residence outside Gentofte Hospital admission area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dept. of Respiratory medicine, UH Gentofte</name>
      <address>
        <city>Hellerup</city>
        <zip>DK-2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>November 19, 2019</last_update_submitted>
  <last_update_submitted_qc>November 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Jon Torgny Wilcke</investigator_full_name>
    <investigator_title>Associate Professor, Pricipal Investigator</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Exacerbation</keyword>
  <keyword>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>
  <patient_data>
    <sharing_ipd>No</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/NCT02987439
org study id: H-2-2013-143
nct id: NCT02987439
lead sponsor: 
has dmc: Yes
Purpose: In a randomized controlled trial we will assess the effect of early pulmonary
      rehabilitation in patient with an acute exacerbation of chronic obstructive lung disease
      (AECOPD).
Background:

      Pulmonary rehabilitation is a key element in treatment of stable COPD. A Cochrane review from
      2011 showed that early pulmonary rehabilitation for COPD exacerbation 6-10 days after
      discharge, or during prolonged hospitalization significantly reduced mortality and
      hospitalizations without serious side effects. It consist of 9 small studies and larger RCT
      studies is required to establish the effect of early pulmonary rehabilitation.

      AIM: The aim of the study is to investigate whether early pulmonary rehabilitation can reduce
      mortality og hospitalization in patients with acute exacerbation of COPD. Secondary increase
      exercise capacity, reduce symptoms and improve quality of life.

      Methods:

      Design: The study is a single center randomized, controlled, open label trial, with an
      intervention group and a control group. The patients are randomized to either a prespecified
      rehabilitation program, which is standardized to patients with COPD, or usual care. The
      patients' data are being recorded at baseline and visits at 2 and 6 months: Lung function
      (FEV1, FVC), CO in exhaled air, O2 saturation in the blood (and possibly O2 supplement),
      Heart Rate, Dyspnoea (Borg scale and Medical Research Council (MRC scale)), Quality of life
      (CAT), Walk Test (ISWT and ESWT), Daily medication, Outdoor activity. Information on
      mortality, hospital admissions, emergency room visits after 6 and 12 months is obtained from
      relevant databases.

      Population: Patients Hospitalized with an exacerbation of COPD to the department of
      respiratory medicine at Gentofte Hospital. The inclusion criteria are: A diagnose of COPD,
      Age >18, expected discharge to own homes, can walk 10 meters independently (with or without a
      walking aid). Exclusion criteria are: Life expectancy <6 months due to another illness
      (cancer, severe heart disease, etc.), difficulties in understanding and speaking Danish (e.g.
      due to dementia), place of residence outside Gentofte Hospital admission area.

      Randomization: A total of 150 COPD patients will be included. The participants are randomized
      to early rehabilitation or usual care in a 1:1 ratio, using a computer-generated
      block-randomization for each center. The participant is presented with a sealed envelope
      containing a piece of paper with either "A" (= REHAB) or "B" (= usual care). The
      randomization list is stored at Gentofte Hospital in a sealed envelope.

      A participant who is readmitted will not be re-randomized.

      Patients arre introduced to an acute telephone hotline, operated by a nurse.

      The patients in the intervention group will during Hospitalization begin the rehabilitation
      program. The program consist of exercise training, breathing techniques and education. Before
      discharge the patients will be assessed to either A: outpatient rehabilitation in hospital or
      community clinic or B: Rehabilitation in their own homes twice weekly in 7 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Composite outcome of 1 year mortality or hospital readmission
time frame: 12 months
description: It is all cause mortality in 12 months follow-up period.. Readmission is the proportion of patients with at least 1 hospital readmission in 12 months follow-up period. Intention-to-treat analysis.Secondarily per-protocol analysis.
measure: All cause mortality and time to death
time frame: 12 months
measure: All cause hospital readmission and time to readmission
time frame: 12 months
description: Proportion of patients with at least 1 hospital readmission of any cause
measure: Hospital readmission by respiratory cause
time frame: 12 months
measure: Health related quality of life
time frame: 6 months
description: Measured by COPD Assessment TEST (CAT)
measure: Dyspnea
time frame: 6 months
description: Measured by Medical Respiratory Council (MRC) dyspnea scale
measure: Exercise performance
time frame: 6 months
description: Composite measure by Incremental Shuttle Walk Test (ISWT) and Endurance Shuttle Walk Test (ESWT)
arm group label: Standard care group
arm group type: No Intervention
description: Standard medical treatment for the exacerbation of COPD
Standard medical treatment of COPD according to GOLD
A visit by a pulmonary nurse at the patients own home 3-5 days after discharge. Lung function and smoking history is recorded. Correct use of inhaler is instructed.
Visit in the outpatient clinic within the next 2-6 months after discharge as follow-up
In the outpatient clinic they will receive an offer of pulmonary rehabilitation
arm group label: Rehabilitation group
arm group type: Experimental
description: The group will begin pulmonary rehabilitation during hospital admission. Afterwards a rehabilitation program twice weekly for 7 weeks.
Beside rehabilitation they will receive same treatment as the standard care group
intervention type: Other
intervention name: Pulmonary rehabilitation
description: The intervention is pulmonary rehabilitation
arm group label: Rehabilitation group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Jon Torgny Wilcke
investigator title: Associate Professor, Pricipal Investigator
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No