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The Impact of Early Pulmonary Rehabilitation on Multidimensional Aspect of Dyspnea in COPD Patients After Exacerbation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulmonary rehabilitation
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized COPD patients with a diagnosis of AECOPD with no clinically significant arterial hypoxemia at rest or on exercise (resting percutaneous oxygen saturation (SpO2) > 90% or a sustained decrease of < 4% during exercise) were recruited. Diagnosis of COPD, AECOPD and spirometric assessment of airflow limitation severity was based on Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Exclusion Criteria:

  • Patients with a prior diagnosis of other cardiorespiratory conditions (i.e., bronchial asthma, interstitial lung diseases, primary pulmonary hypertension, chronic congestive heart failure), as well as other conditions such as orthopedic, muscular and peripheral vascular diseases that could cause or contribute to breathlessness and exercise intolerance and/or could interfere with carrying out of exercise testing, were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    early pulmonary rehabilitation (EPR)

    Usual care (UC)

    Arm Description

    early pulmonary rehabilitation started shortly after hospital discharge for COPD exacerbation.

    No pulmonary rehabilitation for this group

    Outcomes

    Primary Outcome Measures

    change in different aspects of dyspnea (dyspnea 12 questionnaire: scale range 0-36, with high score indicating worse dyspnea, and COPD assessment test: scale range 0-40, high score indicating worse dyspnea).
    dyspnea questionnaires
    change in exercise performance (borg scale during incremental exercise measuring the perceived dyspnea: scale 0-10, higher score indicating worse performance
    cardiopulmonary exercise tests
    change in exercise performance (test duration: longer duration measured in seconds indicating better performance)
    cardiopulmonary exercise tests
    change in exercise performance (Peak oxygen consumption: Higher values indicating better performance)
    cardiopulmonary exercise tests

    Secondary Outcome Measures

    Full Information

    First Posted
    July 10, 2018
    Last Updated
    July 31, 2018
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03611127
    Brief Title
    The Impact of Early Pulmonary Rehabilitation on Multidimensional Aspect of Dyspnea in COPD Patients After Exacerbation
    Official Title
    The Impact of Early Pulmonary Rehabilitation on the Multidimensional Aspects of Dyspnea and Exercise Performance Following Acute Exacerbation of Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 15, 2016 (Actual)
    Primary Completion Date
    August 20, 2017 (Actual)
    Study Completion Date
    August 20, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with severe dyspnea and exercise intolerance. Early pulmonary rehabilitation (EPR) may lead to improvements in dyspnea and exercise tolerance, as it does in stable COPD patients.
    Detailed Description
    One hundred and six patients admitted in a university hospital with AECOPD were randomized after discharge to either EPR for 8 weeks (EPR group) or usual care (UC) (UC group). All patients carried out the following initially and after 8 weeks: spirometry, 6minute walk test (SMWT), and a symptom-limited incremental cycle cardiopulmonary exercise test (CPET), and different dyspnea dimensions evaluation as following: Dyspnea intensity during incremental exercise using Borg scale, dyspnea 12 questionnaire and COPD assessment test (CAT) to assess sensory perceptual, affective distress, and symptom impact domains respectively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    early pulmonary rehabilitation (EPR)
    Arm Type
    Experimental
    Arm Description
    early pulmonary rehabilitation started shortly after hospital discharge for COPD exacerbation.
    Arm Title
    Usual care (UC)
    Arm Type
    No Intervention
    Arm Description
    No pulmonary rehabilitation for this group
    Intervention Type
    Other
    Intervention Name(s)
    pulmonary rehabilitation
    Intervention Description
    pulmonary rehabilitation standardized program
    Primary Outcome Measure Information:
    Title
    change in different aspects of dyspnea (dyspnea 12 questionnaire: scale range 0-36, with high score indicating worse dyspnea, and COPD assessment test: scale range 0-40, high score indicating worse dyspnea).
    Description
    dyspnea questionnaires
    Time Frame
    8 weeks
    Title
    change in exercise performance (borg scale during incremental exercise measuring the perceived dyspnea: scale 0-10, higher score indicating worse performance
    Description
    cardiopulmonary exercise tests
    Time Frame
    8 weeks
    Title
    change in exercise performance (test duration: longer duration measured in seconds indicating better performance)
    Description
    cardiopulmonary exercise tests
    Time Frame
    8 weeks
    Title
    change in exercise performance (Peak oxygen consumption: Higher values indicating better performance)
    Description
    cardiopulmonary exercise tests
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Male
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospitalized COPD patients with a diagnosis of AECOPD with no clinically significant arterial hypoxemia at rest or on exercise (resting percutaneous oxygen saturation (SpO2) > 90% or a sustained decrease of < 4% during exercise) were recruited. Diagnosis of COPD, AECOPD and spirometric assessment of airflow limitation severity was based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Exclusion Criteria: Patients with a prior diagnosis of other cardiorespiratory conditions (i.e., bronchial asthma, interstitial lung diseases, primary pulmonary hypertension, chronic congestive heart failure), as well as other conditions such as orthopedic, muscular and peripheral vascular diseases that could cause or contribute to breathlessness and exercise intolerance and/or could interfere with carrying out of exercise testing, were excluded.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Impact of Early Pulmonary Rehabilitation on Multidimensional Aspect of Dyspnea in COPD Patients After Exacerbation

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