Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease
|ClinicalTrials.gov Identifier: NCT01633697|
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : November 14, 2017
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||Phase|
|COPD||Behavioral: Breathing Behavioral: Education alone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||October 2016|
Subjects will receive education about COPD with special attention to breathing techniques
Sham Comparator: Education-Control
Subjects will receive education alone about COPD.
Behavioral: Education alone
No special attention to breathing
- 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
- 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.
- 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.
- 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.
- 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.
- Dyspnea [ Time Frame: 12 weeks ]Dyspnea will be assessed by questionnaires (Borg, MRC, BDI/TDI) at baseline and at 12 weeks.
- 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.
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||David Kaminsky, MD||University of Vermont|