The Impact of Pulmonary Rehabilitation on Dyspnea in Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT01513616|
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : December 17, 2012
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:
- 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.
- 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.
- 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.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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 weekOther: 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)
- 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)
- 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
- Dyspnea-related anxiety [ Time Frame: 8 weeks ]Intensity of dyspnea-related anxiety measured during cycle exercise testing (Borg scale)
- disease-specific self-efficacy [ Time Frame: 8 weeks ]COPD Self-Efficacy Score
- Pulmonary function [ Time Frame: 8 weeks ]Detailed measurements of pulmonary function: spirometry, body plethysmography, diffusing capacity, maximal respiratory pressures
- Cardiopulmonary exercise test measurements [ Time Frame: 8 weeks ]Physiological measurements obtained during cycle exercise testing
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 ClinicalTrials.gov identifier (NCT number): NCT01513616
|Respiratory Investigation Unit at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|Principal Investigator:||Denis O'Donnell, MD, FRCPC||Queen's University and Kingston General Hospital|