<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/NCT02190461</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-EXA-2013-04</org_study_id>
    <nct_id>NCT02190461</nct_id>
  </id_info>
  <brief_title>Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted COPD Patients</brief_title>
  <official_title>Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spanish Society of Pneumology and Thoracic Surgery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Spanish Clinical Research Network - SCReN</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory&#xD;
      Rehabilitation program with the conventional Respiratory Rehabilitation in COPD re-admitted&#xD;
      patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life&#xD;
      related to health (HRQOL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory&#xD;
      Rehabilitation (ERR) program with the conventional Respiratory Rehabilitation (CRR) in COPD&#xD;
      re-admitted patients. Outcomes will be exacerbations, symptoms, functional capacity and&#xD;
      quality of life related to health (HRQOL). Sixty patients will be randomized into the two&#xD;
      groups: ERR starts the program during admission and continues at home immediately after&#xD;
      discharge for a period of 3 months; CRR was started at home one month after discharge from&#xD;
      hospital and continues for 3 months. Recruitment of patients and starting the RR program will&#xD;
      occur in the first year. In the second year we will continue the intervention to those who&#xD;
      have not completed the year. Follow-up will last until the completion of the year of all&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2013</start_date>
  <completion_date type="Actual">June 9, 2017</completion_date>
  <primary_completion_date type="Actual">June 9, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exacerbations</measure>
    <time_frame>1 year</time_frame>
    <description>Exacerbations with or without admission due to respiratory illness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>1 year</time_frame>
    <description>dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>1 year</time_frame>
    <description>Exercise capacity with the six minutes walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life related to health</measure>
    <time_frame>1 year</time_frame>
    <description>Quality of life related to health from self-administered CAT and CRC questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Early Respiratory Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Respiratory Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Early Respiratory Rehabilitation Program</intervention_name>
    <arm_group_label>Early Respiratory Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Respiratory Rehabilitation Program</intervention_name>
    <arm_group_label>Conventional Respiratory Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 40 years&#xD;
&#xD;
          -  Diagnostic criteria of COPD GOLD II-IV confirmed by spirometry&#xD;
&#xD;
          -  Having frequent re-admissions (≥ 2 times / year).&#xD;
&#xD;
          -  Sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have completed a pulmonary rehabilitation program (including training) in the last 6&#xD;
             months.&#xD;
&#xD;
          -  Respiratory and / or cardiac serious associated diseases.&#xD;
&#xD;
          -  End-stage COPD (inability to perform exercises or treatment with morphine).&#xD;
&#xD;
          -  Prognosis of &lt;6 months.&#xD;
&#xD;
          -  Living in a residence or not having a primary caregiver.&#xD;
&#xD;
          -  Cognitive disorders that prevent active participation.&#xD;
&#xD;
          -  Patients who are admired to other hospitalization rooms than Pneumology.&#xD;
&#xD;
          -  Patients who do not belong to the area of health coverage of the Respiratory&#xD;
             Rehabilitation home team&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fátima E Morante, Nurse</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Servicio de Neumología Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early Respiratory Rehabilitation</keyword>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <keyword>Re-admitted patients</keyword>
  <keyword>Open clinical trial</keyword>
  <keyword>Exacerbations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</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/NCT02190461
org study id: IIBSP-EXA-2013-04
nct id: NCT02190461
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory
      Rehabilitation program with the conventional Respiratory Rehabilitation in COPD re-admitted
      patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life
      related to health (HRQOL).
Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory
      Rehabilitation (ERR) program with the conventional Respiratory Rehabilitation (CRR) in COPD
      re-admitted patients. Outcomes will be exacerbations, symptoms, functional capacity and
      quality of life related to health (HRQOL). Sixty patients will be randomized into the two
      groups: ERR starts the program during admission and continues at home immediately after
      discharge for a period of 3 months; CRR was started at home one month after discharge from
      hospital and continues for 3 months. Recruitment of patients and starting the RR program will
      occur in the first year. In the second year we will continue the intervention to those who
      have not completed the year. Follow-up will last until the completion of the year of all
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Exacerbations
time frame: 1 year
description: Exacerbations with or without admission due to respiratory illness
measure: Dyspnea
time frame: 1 year
description: dyspnea in activities of daily living measured by the area of the dyspnea in the original CRQ questionnaire
measure: Functional capacity
time frame: 1 year
description: Exercise capacity with the six minutes walk test
measure: Quality of life related to health
time frame: 1 year
description: Quality of life related to health from self-administered CAT and CRC questionnaires
arm group label: Early Respiratory Rehabilitation
arm group type: Experimental
description: Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.
arm group label: Conventional Respiratory Rehabilitation
arm group type: Active Comparator
description: Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.
intervention type: Procedure
intervention name: Early Respiratory Rehabilitation Program
arm group label: Early Respiratory Rehabilitation
intervention type: Procedure
intervention name: Conventional Respiratory Rehabilitation Program
arm group label: Conventional Respiratory Rehabilitation
criteria: 
gender: All
minimum age: 41 Years
maximum age: 110 Years
healthy volunteers: No
last name: Fátima E Morante, Nurse
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive