Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633697
• Other study ID #: M12-131
• Secondary ID: 1R34HL113290-01
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: October 2016

Study information

• Verified date: November 2020
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Pranayama
Specific yoga-related breathing method.
• Education alone
No special attention to breathing

Locations

Country	Name	City	State
United States	Vermont Lung Center	Colchester	Vermont
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise tolerance	Exercise tolerance will be measured by 6 min walk distance at baseline and again after 12 weeks of the intervention	12 weeks
Secondary	Dynamic hyperinflation	Dynamic hyperinflation will be measured by changes in inspiratory capacity that occur before and after the 6 min walk test, at baseline, and then again at 12 weeks.	12 weeks
Secondary	Oxidative stress	Oxidative stress will be measured by levels of H2O2, 8-isoprostane, and glutathione in exhaled breath condensate at baseline and again at 12 weeks.	12 weeks
Secondary	Systemic inflammation	Systemic inflammation will be assessed by plasma levels of CRP, IL-6 and red cell distribution width at baseline and at 12 weeks.	12 weeks
Secondary	Lung mechanics	Lung mechanics will be assessed by measurement of respiratory system impedance using the forced oscillation technique at baseline and at 12 weeks.	12 weeks
Secondary	Dyspnea	Dyspnea will be assessed by questionnaires (Borg, MRC, BDI/TDI) at baseline and at 12 weeks.	12 weeks
Secondary	Quality of Life	Quality of life will be assessed by the St. George Respiratory Questionnaire at baseline and at 12 weeks.	12 weeks

External Links

•   Vermont Lung Center