Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease
This study is currently recruiting participants.
Verified April 2013 by University of Vermont
Sponsor:
University of Vermont
Collaborator:
Information provided by (Responsible Party):
David Kaminsky, MD, University of Vermont
ClinicalTrials.gov Identifier:
NCT01633697
First received: June 29, 2012
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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 | Intervention |
|---|---|
|
COPD |
Behavioral: Breathing Behavioral: Education alone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Exercise and Physical Fitness
U.S. FDA Resources
Further study details as provided by University of Vermont:
Primary Outcome Measures:
- Exercise tolerance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Lung mechanics will be assessed by measurement of respiratory system impedance using the forced oscillation technique at baseline and at 12 weeks.
- Dyspnea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Dyspnea will be assessed by questionnaires (Borg, MRC, BDI/TDI) at baseline and at 12 weeks.
- Quality of Life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Quality of life will be assessed by the St. George Respiratory Questionnaire at baseline and at 12 weeks.
| Estimated Enrollment: | 42 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 about COPD.
|
Behavioral: Education alone
No special attention to breathing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633697
Contacts
| Contact: Stephanie Burns | 802-847-2193 | stephanie.burns@vtmednet.org |
Locations
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Melissa Brock 713-873-8772 mbrock@bcm.edu | |
| United States, Vermont | |
| Vermont Lung Center | Recruiting |
| Colchester, Vermont, United States, 05446 | |
| Contact: Stephanie Burns 802-847-2193 stephanie.burns@vtmednet.org | |
Sponsors and Collaborators
University of Vermont
Investigators
| Principal Investigator: | David Kaminsky, MD | University of Vermont |
More Information
Additional Information:
No publications provided
| Responsible Party: | David Kaminsky, MD, Associate Professor of Medicine, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT01633697 History of Changes |
| Other Study ID Numbers: | M12-131, 1R34HL113290-01 |
| Study First Received: | June 29, 2012 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board United States: Data and Safety Monitoring Board |
Keywords provided by University of Vermont:
|
emphysema chronic bronchitis |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013