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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study COPD population | Patients with diagnosis of mild to very severe chronic obstructive pulmonary disease |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pulmonary outpatient clinic
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| Name | Affiliation | Role |
|---|---|---|
| Irma de Godoy, PhD, MD | Botucatu School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Botucatu School of Medicine | Botucatu | São Paulo | 18618-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23425215 | Derived | Ferrari R, Tanni SE, Caram LM, Correa C, Correa CR, Godoy I. Three-year follow-up of Interleukin 6 and C-reactive protein in chronic obstructive pulmonary disease. Respir Res. 2013 Feb 20;14(1):24. doi: 10.1186/1465-9921-14-24. | |
| 22152155 | Derived | Ferrari R, Tanni SE, Caram LM, Naves CR, Godoy I. Predictors of health status do not change over three-year periods and exacerbation makes difference in chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2011 Dec 9;9:112. doi: 10.1186/1477-7525-9-112. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Obstructive Pulmonary Disease Markers Over Three Years | All patients were evaluated at baseline and attended at the clinics every six months for three years or until death. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Obstructive Pulmonary Disease Markers Over Three Years | All patients were evaluated at baseline and attended at the clinics every six months for three years or until death. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The sampling frame for this study was consecutive COPD patients recruited from the outpatient clinic of Botucatu Medical School. | Posted | Sep 2009 | Median | Inter-Quartile Range | Percentage predicted | Baseline and after three years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Obstructive Pulmonary Disease |
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We excluded patients with comorbidities; therefore, many patients seen in clinical practice may not have been well represented in our study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renata Ferrari | HC/FMB-Unesp | 55 14 38116213 | renataferrarifisio@gmail.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Primary | 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. | Posted | Oct 2010 | Mean | Standard Deviation | meters | Baseline and after three years |
|
|
|
| Primary | Body Composition | Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters. | Posted | Oct 2010 | Median | Inter-Quartile Range | Kg/m^2 | Baseline and after three years |
|
|
|
| Primary | 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. | Posted | Oct 2010 | Median | Inter-Quartile Range | Scores on a scale | Baseline and after three years |
|
|
|
| Primary | 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. | Posted | Feb 2011 | Mean | Standard Deviation | Percentage of total score | Baseline and after three years |
|
|
|
| 0 |
| 133 |
| 0 |
| 133 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |