Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pranayama
Education alone
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring emphysema, chronic bronchitis
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)
Sites / Locations
- Baylor College of Medicine
- Vermont Lung Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Education-Pranayama
Education-Control
Arm Description
Subjects will receive education about COPD with special attention to breathing techniques
Subjects will receive education alone about COPD.
Outcomes
Primary Outcome Measures
Exercise tolerance
Exercise tolerance will be measured by 6 min walk distance at baseline and again after 12 weeks of the intervention
Secondary Outcome Measures
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.
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.
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.
Lung mechanics
Lung mechanics will be assessed by measurement of respiratory system impedance using the forced oscillation technique at baseline and at 12 weeks.
Dyspnea
Dyspnea will be assessed by questionnaires (Borg, MRC, BDI/TDI) at baseline and at 12 weeks.
Quality of Life
Quality of life will be assessed by the St. George Respiratory Questionnaire at baseline and at 12 weeks.
Full Information
NCT ID
NCT01633697
First Posted
June 29, 2012
Last Updated
November 2, 2020
Sponsor
University of Vermont
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01633697
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
emphysema, chronic bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education-Pranayama
Arm Type
Experimental
Arm Description
Subjects will receive education about COPD with special attention to breathing techniques
Arm Title
Education-Control
Arm Type
Sham Comparator
Arm Description
Subjects will receive education alone about COPD.
Intervention Type
Behavioral
Intervention Name(s)
Pranayama
Other Intervention Name(s)
Dirgha 3-Part Breathing method
Intervention Description
Specific yoga-related breathing method.
Intervention Type
Behavioral
Intervention Name(s)
Education alone
Intervention Description
No special attention to breathing
Primary Outcome Measure Information:
Title
Exercise tolerance
Description
Exercise tolerance will be measured by 6 min walk distance at baseline and again after 12 weeks of the intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Dynamic hyperinflation
Description
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.
Time Frame
12 weeks
Title
Oxidative stress
Description
Oxidative stress will be measured by levels of H2O2, 8-isoprostane, and glutathione in exhaled breath condensate at baseline and again at 12 weeks.
Time Frame
12 weeks
Title
Systemic inflammation
Description
Systemic inflammation will be assessed by plasma levels of CRP, IL-6 and red cell distribution width at baseline and at 12 weeks.
Time Frame
12 weeks
Title
Lung mechanics
Description
Lung mechanics will be assessed by measurement of respiratory system impedance using the forced oscillation technique at baseline and at 12 weeks.
Time Frame
12 weeks
Title
Dyspnea
Description
Dyspnea will be assessed by questionnaires (Borg, MRC, BDI/TDI) at baseline and at 12 weeks.
Time Frame
12 weeks
Title
Quality of Life
Description
Quality of life will be assessed by the St. George Respiratory Questionnaire at baseline and at 12 weeks.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kaminsky, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Vermont Lung Center
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.med.uvm.edu/vermontlung/HP-DEPT.asp?SiteAreaID=513
Description
Vermont Lung Center
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Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease
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