Intervention group (n=43) | Control group (n=44) | Between group | Effect size | |||
BL Means (SD) | 3M Means (SD) | BL Means (SD) | 3M Means (SD) | LS means difference of change BL to 3M (95% CI) P value | ||
VO2max, mL/kg/min* | 26.2 (5.30) | 29.2 (6.70) | 26.4 (6.50) | 25.7 (5.90) | 3.71 (2.16 to 5.25) <0.0001 | 1.06 |
ITT | ||||||
VO2max, mL/kg/min† | 3.71 (2.16 to 5.25) <0.0001 | |||||
Per protocol | ||||||
VO2max, mL/kg/min‡ | 26.8 (5.30) | 30.1 (6.60) | 26.4 (6.50) | 25.7 (5.90) | 4.1 (2.43 to 5.77) <0.0001 | 1.14 |
Values are shown as mean and SD, unless indicated otherwise.
*Primary analysis adjusted for BL age, VO2max and sex.
†Multiple stochastic imputation of 100 dataset adjusted for the minimisation variables.
‡Complementary analysis including patients attending ≥70% of supervised exercise sessions (n=33), adjusted for BL age, VO2max and sex.
VO2max, weight-corrected maximal oxygen uptake.