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

NCT ID: NCT01633697

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-10-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Education-Pranayama

Subjects will receive education about COPD with special attention to breathing techniques

Group Type: EXPERIMENTAL

Pranayama

Intervention Type: BEHAVIORAL

Specific yoga-related breathing method.

Education-Control

Subjects will receive education alone about COPD.

Group Type: SHAM_COMPARATOR

Education alone

Intervention Type: BEHAVIORAL

No special attention to breathing

Interventions

Pranayama

Specific yoga-related breathing method.

Intervention Type: BEHAVIORAL

Education alone

No special attention to breathing

Intervention Type: BEHAVIORAL

Other Intervention Names

Dirgha 3-Part Breathing method

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

David Kaminsky, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Kaminsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Baylor College of Medicine

Houston, Texas, United States

Vermont Lung Center

Colchester, Vermont, United States

Countries

United States

Related Links

http://www.med.uvm.edu/vermontlung/HP-DEPT.asp?SiteAreaID=513

Vermont Lung Center

Other Identifiers

1R34HL113290-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

M12-131

Identifier Type: -

Identifier Source: org_study_id