Chronic Obstructive Pulmonary Disease Markers and Prognosis
The study aim is to verify the association between the changes in markers of disease and patient´s prognosis in chronic obstructive pulmonary disease.
Chronic Obstructive Pulmonary Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease|
- Forced Expiratory Volume in the First Second (FEV1) [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.
- Exercise Tolerance [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]Tolerance exercise was evaluated by six-minute walking distance(6MWD)according to the American Thoracic Society guidelines.Patients were instructed to walk, attempting to cover as much ground as possible within 6 min. A research assistant timed the walk, and standardized verbal encouragement was given.
- Body Composition [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.
- Dyspnea [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]Dyspnea was evaluated by Medical Research Council scale (MRC). MRC scale consists of only five items and it is based on activities that cause dyspnea. The patient reports the degree of dyspnea by choosing a value between 1 and 5. A higher number indicates greater sensation of dyspnea.
- Health Status [ Time Frame: Baseline and after three years ] [ Designated as safety issue: Yes ]Saint George's Respiratory Questionnaire (SGRQ)was used to evaluate patient's health status. SGRQ includes three domains: symptoms, activities and impact of the disease. Each domain has a minimum score (zero) and maximum (662.5, 1209.1, and 2117.8, respectively). A total score is also calculated based on the results of three domains, with a score maximum of 3989.4. The total score is referred to as the percentage achieved by the patient related to this maximum score. Minimum score means there is no impairment in the health status and high score means maximum dysfunction.
|Study Start Date:||January 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Study COPD population
Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease
In a previous study, 133 COPD patients were followed-up during the period of one-year. Analyses of the association between baseline characteristic and the occurence of disease exacerbation was performed. In this study, the patients included in the previous research will be contacted and invited to participate in a complete evaluation after a three-year period. The association of the changes in dyspnea perception, spirometry variables, body composition, quality of life and exercise tolerance measures with disease prognostic will be studied.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605540
|Botucatu School of Medicine|
|Botucatu, SP, Brazil, 18618-000|
|Study Chair:||Irma de Godoy, PhD, MD||Botucatu School of Medicine|