Chronic Obstructive Pulmonary Disease Markers and Prognosis

Study Overview
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Brief Summary
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The study aim is to verify the association between the changes in markers of disease and patient´s prognosis in chronic obstructive pulmonary disease.

Detailed Description
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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.

Official Title
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Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD diagnosis according to the GOLD criteria Exclusion Criteria: Asthma Inability to perform pulmonary function and exercise tolerance tests Recent myocardial infarction or unstable angina Congestive heart failure: class III/IV

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study COPD population<br>Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in the First Second (FEV1) | FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol. | Baseline and after three years | 
| Exercise Tolerance | 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. | Baseline and after three years | 
| Body Composition | Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters. | Baseline and after three years | 
| Dyspnea | 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. | Baseline and after three years | 
| Health Status | 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. | Baseline and after three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Survival, Exacerbation, Disease markers