Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2017 |
| Start Date: | September 2012 |
| End Date: | October 2016 |
The investigators hypothesize that education will improve exercise capacity, symptoms and
quality of life in patients with chronic obstructive pulmonary disease (COPD). In addition,
the investigators are interested in determining how education might alter various chemicals
in the blood and exhaled breath that reflect inflammation in the lungs and the body as a
whole.
The investigators plan to enroll 42 patients into this study, with half of them participating
at each of the two sites, Vermont Lung Center at the University of Vermont in Burlington,
Vermont, and at Baylor College of Medicine in Houston, Texas. Participants will undergo a
series of measurements and tests at the beginning of the study, receive formal education
about COPD over the next 2 weeks, return at 6 weeks for a brief refresher session, and
finally return after 12 weeks for repeat measurement and testing as was done at the
beginning. Participants will be asked to keep a diary of symptoms, medication, and exercise
during the study.
quality of life in patients with chronic obstructive pulmonary disease (COPD). In addition,
the investigators are interested in determining how education might alter various chemicals
in the blood and exhaled breath that reflect inflammation in the lungs and the body as a
whole.
The investigators plan to enroll 42 patients into this study, with half of them participating
at each of the two sites, Vermont Lung Center at the University of Vermont in Burlington,
Vermont, and at Baylor College of Medicine in Houston, Texas. Participants will undergo a
series of measurements and tests at the beginning of the study, receive formal education
about COPD over the next 2 weeks, return at 6 weeks for a brief refresher session, and
finally return after 12 weeks for repeat measurement and testing as was done at the
beginning. Participants will be asked to keep a diary of symptoms, medication, and exercise
during the study.
Chronic obstructive pulmonary disease (COPD) is a major health problem worldwide, and is
currently the third leading cause of death in the United Sates. Patients with COPD mainly
complain of shortness of breath with daily activities and exercise. A key mechanism of
dyspnea is dynamic hyperinflation, or air trapping, which results from the severe airflow
limitation that characterizes the disease. Inhaled bronchodilators and corticosteroids may
help, but these therapies are expensive and may have side effects. Pulmonary rehabilitation
is very effective at reducing dyspnea and improving exercise tolerance, but it is not widely
available to patients. We propose studying the effect of a simple breathing exercise known as
pranayama, or yogic breathing. Our hypothesis is that the practice of pranayama will improve
exercise tolerance in patients with COPD. We believe that the mechanisms involved will
include reduced dynamic hyperinflation as well as beneficial effects on lung mechanics,
inflammation and oxidative stress. This hypothesis will be tested in a randomized, double
blind, controlled trial of pranayama vs. usual care (education) in COPD patients. In Specific
Aim 1, we will determine the effect of pranayama on exercise tolerance as measured by 6 min
walk distance; in Specific Aim 2, we will determine the effect of pranayama on dynamic
hyperinflation as measured by changes in inspiratory capacity before and after exercise; and
in Specific Aim 3, we will determine the effect of pranayama on oxidative stress systemic
inflammation, shortness of breath, and quality of life. The study is designed to be
applicable to a wide variety of clinical settings, since it will involve two diverse clinical
sites (Burlington, VT and Houston, TX), require minimal direct intervention, and engage
participants in self-learning and practice. The data from this study will provide fundamental
new insights into the mechanisms of action of pranayama, and will be critical in designing a
large, multicenter trial to test the effectiveness of pranayama in patients with COPD.
currently the third leading cause of death in the United Sates. Patients with COPD mainly
complain of shortness of breath with daily activities and exercise. A key mechanism of
dyspnea is dynamic hyperinflation, or air trapping, which results from the severe airflow
limitation that characterizes the disease. Inhaled bronchodilators and corticosteroids may
help, but these therapies are expensive and may have side effects. Pulmonary rehabilitation
is very effective at reducing dyspnea and improving exercise tolerance, but it is not widely
available to patients. We propose studying the effect of a simple breathing exercise known as
pranayama, or yogic breathing. Our hypothesis is that the practice of pranayama will improve
exercise tolerance in patients with COPD. We believe that the mechanisms involved will
include reduced dynamic hyperinflation as well as beneficial effects on lung mechanics,
inflammation and oxidative stress. This hypothesis will be tested in a randomized, double
blind, controlled trial of pranayama vs. usual care (education) in COPD patients. In Specific
Aim 1, we will determine the effect of pranayama on exercise tolerance as measured by 6 min
walk distance; in Specific Aim 2, we will determine the effect of pranayama on dynamic
hyperinflation as measured by changes in inspiratory capacity before and after exercise; and
in Specific Aim 3, we will determine the effect of pranayama on oxidative stress systemic
inflammation, shortness of breath, and quality of life. The study is designed to be
applicable to a wide variety of clinical settings, since it will involve two diverse clinical
sites (Burlington, VT and Houston, TX), require minimal direct intervention, and engage
participants in self-learning and practice. The data from this study will provide fundamental
new insights into the mechanisms of action of pranayama, and will be critical in designing a
large, multicenter trial to test the effectiveness of pranayama in patients with COPD.
Inclusion Criteria:
- Men and women, aged 18 and older, with a physician diagnosis of COPD
- COPD defined according to GOLD criteria, with FEV1/FVC < 0.7, and FEV1 < 80%
predicted.
- Current non-smoker
- Stable medical regimen for COPD over last 4 weeks
- Stable physical activity over the last 4 weeks, with no plans for any change during
the duration of the study
- MRC Dyspnea Scale > 2
- Not planning to engage in any formal pulmonary rehabilitation program during the time
of the study
- No use of any nutritional supplements other than standard multivitamins
Exclusion Criteria:
- Exacerbation of disease within previous 2 weeks
- Concomitant other respiratory disease or significant cardiovascular disease
- Previous practice of yoga
- Current use of antioxidant supplements (e.g., vitamin C, vitamin E, n-acetylcysteine)
We found this trial at
2
sites
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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