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

Study Overview
=================
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: 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?

Official Title
-----------------
Mechanisms of Dyspnea Relief Following Exercise Training in COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Pulmonary rehabilitation
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary rehabilitation<br>A supervised 8-wk outpatient pulmonary rehabilitation program consisting of multi-modality exercise training and COPD self-management education. | Other: Pulmonary rehabilitation<br>* 8-week program, 3 supervised session per week<br>|
| Sham Comparator: Usual care control<br>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<br>* 8-week program, 3 supervised session per week<br>Other: Usual care<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exertional dyspnea intensity | 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) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional measurements of dyspnea and physiological measurements | Activity-related dyspnea: MRC dyspnea scale, Transition Dyspnea Index, CRQ dyspnea component, SGRQ activity component | 8 weeks | 
| Dyspnea-related anxiety | Intensity of dyspnea-related anxiety measured during cycle exercise testing (Borg scale) | 8 weeks | 
| disease-specific self-efficacy | COPD Self-Efficacy Score | 8 weeks | 
| Pulmonary function | Detailed measurements of pulmonary function: spirometry, body plethysmography, diffusing capacity, maximal respiratory pressures | 8 weeks | 
| Cardiopulmonary exercise test measurements | Physiological measurements obtained during cycle exercise testing | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, dyspnea, exercise, measurement, respiratory physiology