Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease
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.
|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|
- 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
- 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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Subjects will receive education about COPD with special attention to breathing techniques
Sham Comparator: Education-Control
Subjects will receive education about COPD.
Behavioral: Education alone
No special attention to breathing
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633697
|Contact: Stephanie Burnsfirstname.lastname@example.org|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Melissa Brock 713-873-8772 email@example.com|
|United States, Vermont|
|Vermont Lung Center||Recruiting|
|Colchester, Vermont, United States, 05446|
|Contact: Stephanie Burns 802-847-2193 firstname.lastname@example.org|
|Principal Investigator:||David Kaminsky, MD||University of Vermont|