Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Survival, Exacerbation, Disease markers
Brief summary
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
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.
Interventions
None listed
Sponsors
UPECLIN HC FM Botucatu Unesp
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in the First Second (FEV1) | Baseline and after three years | FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol. |
| Exercise Tolerance | Baseline and after three years | 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 | Baseline and after three years | Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters. |
| Dyspnea | Baseline and after three years | 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 | Baseline and after three years | 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. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 133 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 15 |
| Overall Study | Lost to Follow-up | 23 |
Baseline characteristics
| Characteristic | Chronic Obstructive Pulmonary Disease Markers Over Three Years |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 67 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants |
| Age, Continuous | 64.8 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment Brazil | 133 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 133 |
| serious Total, serious adverse events | 0 / 133 |
Outcome results
Primary
Body Composition
Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.
Time frame: Baseline and after three years
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Body Composition | Baseline assessment | 25 Kg/m^2 |
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Body Composition | After three-year assessment | 25 Kg/m^2 |
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.
Time frame: Baseline and after three years
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Dyspnea | Baseline assessment | 1 Scores on a scale |
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Dyspnea | After three-year assessment | 2 Scores on a scale |
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.
Time frame: Baseline and after three years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Exercise Tolerance | After three-year assessment | 412 meters | Standard Deviation 100 |
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Exercise Tolerance | Baseline assessment | 438 meters | Standard Deviation 86 |
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.
Time frame: Baseline and after three years
Population: The sampling frame for this study was consecutive COPD patients recruited from the outpatient clinic of Botucatu Medical School.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Forced Expiratory Volume in the First Second (FEV1) | Baseline assessment | 54 Percentage predicted |
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Forced Expiratory Volume in the First Second (FEV1) | After three-year assessment | 54 Percentage predicted |
Comparison: All data were analyzed using SigmaStat 3.2 (Inc., USA) software. Mean ± SD or median interquartile range (25-75%) was used depending on the data distribution. Wilcoxon test was applied to compare the characteristics at baseline to those observed after 3 years.p-value: 0.09Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline and after three years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Health Status | Baseline assessment | 42 Percentage of total score | Standard Deviation 19 |
| Chronic Obstructive Pulmonary Disease Markers Over Three Years | Health Status | After three-year assessment | 44 Percentage of total score | Standard Deviation 19 |