Clinical trial NCT01633697: Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease
Official title: Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: emphysema
chronic bronchitis
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-07-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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. The investigators propose studying the effect of a simple breathing exercise known as pranayama, or yogic breathing. The central hypothesis is that the practice of pranayama will improve exercise tolerance in patients with COPD. The investigators 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, the investigators will determine the effect of pranayama on exercise tolerance as measured by 6 min walk distance; in Specific Aim 2, the investigators 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, The investigators 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Exercise tolerance
timeFrame: 12 weeks
Secondary outcomes:
measure: Dynamic hyperinflation
timeFrame: 12 weeks
measure: Oxidative stress
timeFrame: 12 weeks
measure: Systemic inflammation
timeFrame: 12 weeks
measure: Lung mechanics
timeFrame: 12 weeks
measure: Dyspnea
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Colchester
country: United States
facility: Vermont Lung Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: David Kaminsky, MD
role: PRINCIPAL_INVESTIGATOR
References: