Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Mechanisms of Dyspnea Relief Following Exercise Training in COPD
Verified date | December 2012 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 48 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Respiratory Investigation Unit at Kingston General Hospital | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Multidimensional measurements of dyspnea and physiological measurements | Activity-related dyspnea: MRC dyspnea scale, Transition Dyspnea Index, CRQ dyspnea component, SGRQ activity component | 8 weeks | No |
Secondary | Dyspnea-related anxiety | Intensity of dyspnea-related anxiety measured during cycle exercise testing (Borg scale) | 8 weeks | No |
Secondary | disease-specific self-efficacy | COPD Self-Efficacy Score | 8 weeks | No |
Secondary | Pulmonary function | Detailed measurements of pulmonary function: spirometry, body plethysmography, diffusing capacity, maximal respiratory pressures | 8 weeks | No |
Secondary | Cardiopulmonary exercise test measurements | Physiological measurements obtained during cycle exercise testing | 8 weeks | No |
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