Table 1.
Baseline characteristics of the patients aleatorized and analyzed at the start of the study
| Characteristics of the patients | Aleatorization
|
Analyzed
|
||||
|---|---|---|---|---|---|---|
| Control
|
Intervention
|
P-value | Control
|
Intervention
|
P-value | |
| N: 45 | N: 51 | N: 38 | N: 47 | |||
| Male/female | 40 (88.9%)/5 (11.1%) | 47 (92.2%)/4 (7.8%) | 0.730 | 34 (89.5%)/4 (10.5%) | 44 (93.6%)/3 (6.4%) | 0.695 |
| Age | 67.1±6.8 | 68.2±7.2 | 0.437 | 67.7±6.9 | 68.5±7.3 | 0.618 |
| Body mass index | 26.4±8.9 | 25.6±10.1 | 0.698 | 25.6±9.7 | 25.7±10.5 | 0.674 |
| Social risk scale | 5.1±3.1 | 5.1±2.8 | 0.950 | 5.3±3.2 | 5.1±2.9 | 0.864 |
| Comorbidity index | 1 (1.2) | 1 (1.2) | 0.552 | 1 (1.2) | 1 (1.2) | 0.849 |
| Active smoker | 16 (35.6%) | 19 (37.3%) | 0.562 | 14 (36.8%) | 19 (40.4%) | 0.520 |
| Pack-years index | 52.5±26.2 | 56.9±44.3 | 0.565 | 53.1±28.3 | 57.7±46.1 | 0.586 |
| Quality of life (CAT) | 14.1±6.4 | 17.8±6.4 | 0.334 | 14.6±6.8 | 12.9±6.7 | 0.286 |
| Dyspnea (mMRC) | 2 (2.3) | 2 (1.3) | 0.348 | 2 (2.3) | 2 (1.3) | 0.261 |
| FEV1 (%) | 44.3±11.9 | 47.3±14.4 | 0.270 | 45.2±12.7 | 47.2±14.7 | 0.519 |
| Severe COPD | 11 (24.4%) | 14 (27.4%) | 0.918 | 9 (20%) | 14 (27.4%) | 0.700 |
| Very severe COPD | 30 (66.7%) | 34 (66.7%) | 0.829 | 25 (65.8%) | 30 (63.8%) | 0.968 |
| Hospitalization due to COPD | 33 (73.3%) | 35 (68.6%) | 0.613 | 29 (76.3%) | 31 (66%) | 0.297 |
| No hospitalization | 1 (1.2) | 1 (0.1) | 0.712 | 1 (1.2) | 1 (0.1) | 0.261 |
| Emergency visits due to COPD | 29 (64.4%) | 50 (58.8%) | 0.572 | 22 (57.9%) | 27 (57.4%) | 0.967 |
| No emergency room visits | 1 (0.2) | 1 (0.2) | 0.308 | 1 (0.2) | 1 (0.2) | 0.435 |
Note: Values given as number (%), mean ± SD or median (quartiles 1 and 3).
Abbreviations: CAT, COPD Assessment Test; FEV1, forced expiratory volume in 1 second; mMRC, modified Medical Research Council; N, number; SD, standard deviation.