Variables | Total | Tio/Olo 5 µg/5 µg+SMBM+ExT | Tio/Olo 5 µg/5 µg+SMBM | Tio 5 µg+SMBM | Placebo+SMBM | Overall p-value |
n=262 | n=65 | n=69 | n=64 | n=64 | ||
Age, years | 65.0±6.3 | 65.0±6.2 | 64.9±7.1 | 65.6±6.1 | 64.8±6.0 | 0.85 |
Sex, male gender, n (%) | 174 (66.4) | 39 (60.0) | 42 (60.9) | 48 (75.0) | 45 (70.3) | 0.195 |
Current smokers, n (%) | 96 (36.6) | 24 (36.9) | 26 (37.7) | 21 (32.8) | 25 (39.1) | 0.896 |
mMRC | 1.3±0.9 | 1.3±0.9 | 1.3±0.9 | 1.3±0.8 | 1.5±0.8 | 0.626 |
SGRQ activity | 55.7±19.5 | 56.0±20.0 | 55.6±21.3 | 54.7±19.4 | 56.4±17.6 | 0.954 |
FEV1, % predicted | 48.4±13.4 | 48.4±13.2 | 49.5±13.0 | 48.6±14.2 | 47.0±13.3 | 0.688 |
FEV1/FVC, % | 46.8±10.6 | 45.7±9.6 | 48.6±12.2 | 46.5±9.9 | 46.4±10.6 | 0.662 |
Steps per week | 37 684.5±19 996.9 | 38 141.6±19 210.1 | 38 253.9±21 242.9 | 36 651.3±19 455.1 | 36 602.3±20 307.7 | 0.837 |
Walking duration per week, min | 464.1±226.1 | 466.2±216.3 | 477.4±243.6 | 457.1±217.7 | 456.4±229.6 | 0.943 |
TSRQ autonomous regulation | 5.9±1.1 | 6.1±0.9 | 6.1±1.1 | 5.7±1.4 | 5.7±1.1 | 0.200 |
TSRQ controlled regulation | 3.0±1.3 | 3.0±1.3 | 3.0±1.2 | 2.9±1.2 | 3.1±1.4 | 0.962 |
PCS score | 5.4±1.4 | 5.6±1.1 | 5.6±1.2 | 5.1±1.5 | 5.1±1.5 | 0.152 |
Stage of change scale | 3.5±1.1 | 3.6±1.0 | 3.5±1.1 | 3.4±1.2 | 3.3±1.1 | 0.421 |
Stage of change scale (1–5), n (%) | 0.162 | |||||
1 | 8 (3.1) | 0 (0.0) | 3 (4.4) | 2 (3.1) | 3 (4.7) | |
2 | 47 (17.9) | 9 (13.9) | 9 (13.0) | 18 (28.1) | 11 (17.2) | |
3 | 78 (30.0) | 21 (32.3) | 21 (30.4) | 13 (20.3) | 23 (35.9) | |
4 | 75 (28.6) | 19 (29.2) | 25 (36.2) | 14 (21.9) | 17 (26.6) | |
5 | 54 (20.6) | 16 (24.6) | 11 (15.9) | 17 (26.6) | 10 (15.6) |
Data are presented as mean±sd unless otherwise specified. ExT: exercise training; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; mMRC: modified Medical Research Council; PCS: Perceived Competence Scale; SGRQ: St George's Respiratory Questionnaire; SMBM: self-management behaviour modification; Tio: tiotropium; Tio/Olo: tiotropium/olodaterol; TSRQ: Treatment Self-Regulation Questionnaire.