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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633697
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : November 14, 2017
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Kaminsky, MD, University of Vermont

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.

Condition or disease Intervention/treatment
COPD Behavioral: Breathing Behavioral: Education alone

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. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : September 2012
Primary Completion Date : November 2015
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Education-Breathing
Subjects will receive education about COPD with special attention to breathing techniques
Behavioral: Breathing
Breathing techniques
Sham Comparator: Education-Control
Subjects will receive education alone about COPD.
Behavioral: Education alone
No special attention to breathing

Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: 12 weeks ]
    Exercise tolerance will be measured by 6 min walk distance at baseline and again after 12 weeks of the intervention

Secondary Outcome Measures :
  1. Dynamic hyperinflation [ Time Frame: 12 weeks ]
    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.

  2. Oxidative stress [ Time Frame: 12 weeks ]
    Oxidative stress will be measured by levels of H2O2, 8-isoprostane, and glutathione in exhaled breath condensate at baseline and again at 12 weeks.

  3. Systemic inflammation [ Time Frame: 12 weeks ]
    Systemic inflammation will be assessed by plasma levels of CRP, IL-6 and red cell distribution width at baseline and at 12 weeks.

  4. Lung mechanics [ Time Frame: 12 weeks ]
    Lung mechanics will be assessed by measurement of respiratory system impedance using the forced oscillation technique at baseline and at 12 weeks.

  5. Dyspnea [ Time Frame: 12 weeks ]
    Dyspnea will be assessed by questionnaires (Borg, MRC, BDI/TDI) at baseline and at 12 weeks.

  6. Quality of Life [ Time Frame: 12 weeks ]
    Quality of life will be assessed by the St. George Respiratory Questionnaire at baseline and at 12 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01633697

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Vermont
Vermont Lung Center
Colchester, Vermont, United States, 05446
Sponsors and Collaborators
University of Vermont
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: David Kaminsky, MD University of Vermont

Additional Information:
Responsible Party: David Kaminsky, MD, Associate Professor of Medicine, University of Vermont Identifier: NCT01633697     History of Changes
Other Study ID Numbers: M12-131
1R34HL113290-01 ( U.S. NIH Grant/Contract )
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by David Kaminsky, MD, University of Vermont:
chronic bronchitis

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases