TABLE 2.
Total (n=262) | Tio/Olo 5 µg/5 µg+SMBM+ExT (n=65) | Tio/Olo 5 µg/5 µg+SMBM (n=69) | Tio 5 µg+SMBM (n=64) | Placebo+SMBM (n=64) | Overall p-value¶ | ||||||
Changes in variables | Change after 12 weeks | p-value# | Change after 12 weeks | p-value# | Change after 12 weeks | p-value# | Change after 12 weeks | p-value# | Change after 12 weeks | p-value# | The four groups comparison |
PA variables | |||||||||||
Steps per week | 6038.2 (3674.3–8401.4) | <0.001* | 5028.1 (608.3–9447.9) | 0.006* | 11 141.9 (6487.6–15 796.2) | <0.001* | 1904.7 (−1619.8–5429.9) | 0.284 | 5923.4 (−266.0–12 112.1) | 0.023* | 0.099 |
Walking duration, in min | 61.6 (36.4–86.8) | <0.001* | 53.2 (4.2–101.5) | 0.007* | 110.6 (62.3–159.6) | <0.001* | 23.1 (−17.5–64.4) | 0.262 | 58.1 (−7.7–123.9) | 0.047* | 0.188 |
Behaviour | |||||||||||
TSRQ autonomous regulation | 0.2 (0.1–0.3) | 0.002* | 0.0 (−0.2–0.2) | 0.516 | 0.2 (0.0–0.4) | 0.105 | 0.3 (0.0–0.6) | 0.027* | 0.2 (0.0–0.4) | 0.086 | 0.424 |
TSRQ controlled regulation | 0.1 (0.0–0.3) | 0.165 | 0.0 (−0.3–0.3) | 1.000 | 0.1 (−0.2–0.4) | 0.721 | 0.2 (−0.1–0.5) | 0.166 | 0.1 (−0.2–0.4) | 0.423 | 0.698 |
PCS score | 0.5 (0.3–0.6) | <0.001* | 0.4 (0.1–0.7) | 0.003* | 0.5 (0.2–0.7) | <0.001* | 0.6 (0.3–0.9) | <0.001* | 0.5 (0.2–0.9) | <0.001* | 0.953 |
Stage of change scale | 0.7 (0.6–0.8) | <0.001* | 0.6 (0.4–0.9) | <0.001* | 0.8 (0.5–1.0) | <0.001* | 0.7 (0.4–1.0) | <0.001* | 0.8 (0.5–1.0) | <0.001* | 0.767 |
Data are presented as mean (95% CI).
ExT: exercise training; PA: physical activity; PCS: Perceived Competence Scale; SMBM: self-management behaviour modification; Tio: tiotropium; Tio/Olo: tiotropium/olodaterol; TSRQ: Treatment Self-Regulation Questionnaire. #: p-values were obtained by performing paired t-test or Wilcoxon signed rank test; ¶: p-values were obtained by performing ANOVA or Kruskal–Wallis test; *: p<0.05.