TABLE 2

Changes in PA and mediating variables for the full analysis set (n=262) and by treatment groups at 12 weeks as compared with baseline

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 variablesChange after 12 weeksp-value#Change after 12 weeksp-value#Change after 12 weeksp-value#Change after 12 weeksp-value#Change after 12 weeksp-value#The four groups comparison
PA variables
 Steps per week6038.2 (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)0.2845923.4 (−266.0–12 112.1)0.023*0.099
 Walking duration, in min61.6 (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)0.26258.1 (−7.7–123.9)0.047*0.188
Behaviour
 TSRQ autonomous regulation0.2 (0.1–0.3)0.002*0.0 (−0.2–0.2)0.5160.2 (0.0–0.4)0.1050.3 (0.0–0.6)0.027*0.2 (0.0–0.4)0.0860.424
 TSRQ controlled regulation0.1 (0.0–0.3)0.1650.0 (−0.3–0.3)1.0000.1 (−0.2–0.4)0.7210.2 (−0.1–0.5)0.1660.1 (−0.2–0.4)0.4230.698
 PCS score0.5 (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 scale0.7 (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.