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The Impact of Pulmonary Rehabilitation on Dyspnea in Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01513616
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : December 17, 2012
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University

Brief Summary:

Dyspnea (respiratory discomfort) and activity limitation are the most common symptoms of chronic obstructive pulmonary disease (COPD) and contribute importantly to a perceived poor quality of life. Recent international guidelines have stressed the importance of dyspnea alleviation and improvement exercise tolerance as a means of enhancing quality of life and other long term outcomes in this population. Modern pharmacotherapy is the first step in symptom management but the overall impact of bronchodilator therapy is relatively small. Exercise training remains the most effective treatment for ameliorating dyspnea and improving exercise endurance and was the main focus of this study.

The main objectives of the study were:

  1. To conduct and compare detailed studies of respiratory mechanics during cycle exercise before and after exercise training (EXT) compared with an untrained control group. By multiple regression analysis, the investigators will establish the main contributors to dyspnea relief after EXT.
  2. To compare the magnitude of change in endurance during constant work rate cycle exercise with those measured during walk tests and the endurance shuttle walk test after EXT relative to control. To evaluate which test (constant work rate cycle, six-minute walk test, or endurance shuttle walk test) is the most sensitive test for measuring changes in endurance after EXT versus control.
  3. To compare the change in standardized dyspnea ratings (Borg Scale) during constant-load cycling with a variety of other activity-related dyspnea questionnaires. To evaluate which of these measurements is the most sensitive for examining changes in perceived discomfort during exercise.
  4. To evaluate the contribution of psychological factors (anxiety, fear, respiratory panic, self-efficacy) to the perceived improvement of symptoms following EXT. The investigators will use multiple regression analysis to examine associations between changes in perceived dyspnea and changes in anxiety and self-efficacy measured by validated questionnaires and Borg intensity ratings?

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Pulmonary rehabilitation Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms of Dyspnea Relief Following Exercise Training in COPD
Study Start Date : November 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pulmonary rehabilitation
A supervised 8-wk outpatient pulmonary rehabilitation program consisting of multi-modality exercise training and COPD self-management education.
Other: Pulmonary rehabilitation
8-week program, 3 supervised session per week

Sham Comparator: Usual care control
An 8-wk control period consisting of usual medical care which included optimization of respiratory medications, instructions on how best to manage COPD, standard access to treatment in the event of an exacerbation, self-management education.
Other: Pulmonary rehabilitation
8-week program, 3 supervised session per week

Other: Usual care
An 8-week control period (includes optimization of respiratory medications, instructions on how best to manage COPD, standard access to treatment in the event of an exacerbation, self-management education)

Primary Outcome Measures :
  1. Exertional dyspnea intensity [ Time Frame: 8 weeks ]
    Post-intervention comparisons (pulmonary rehabilitation vs. usual care control) of dyspnea measurements (i.e., Borg ratings at a standardized time during high-intensity constant-work rate cycle exercise testing)

Secondary Outcome Measures :
  1. Multidimensional measurements of dyspnea and physiological measurements [ Time Frame: 8 weeks ]
    Activity-related dyspnea: MRC dyspnea scale, Transition Dyspnea Index, CRQ dyspnea component, SGRQ activity component

  2. Dyspnea-related anxiety [ Time Frame: 8 weeks ]
    Intensity of dyspnea-related anxiety measured during cycle exercise testing (Borg scale)

  3. disease-specific self-efficacy [ Time Frame: 8 weeks ]
    COPD Self-Efficacy Score

  4. Pulmonary function [ Time Frame: 8 weeks ]
    Detailed measurements of pulmonary function: spirometry, body plethysmography, diffusing capacity, maximal respiratory pressures

  5. Cardiopulmonary exercise test measurements [ Time Frame: 8 weeks ]
    Physiological measurements obtained during cycle exercise testing

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosis of COPD
  • clinically stable
  • presence of activity-related dyspnea (Baseline Dyspnea Index < 9)
  • 40-80 years of age

Exclusion Criteria:

  • other significant disorders or diseases that could interfere with conduct of the intervention or tests
  • body mass index < 18 or > 40 kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01513616

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Canada, Ontario
Respiratory Investigation Unit at Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
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Principal Investigator: Denis O'Donnell, MD, FRCPC Queen's University and Kingston General Hospital

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Responsible Party: Dr. Denis O'Donnell, Principal Investigator, Queen's University Identifier: NCT01513616     History of Changes
Other Study ID Numbers: DMED-986-06
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012
Keywords provided by Dr. Denis O'Donnell, Queen's University:
respiratory physiology
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms