Intention-to-treat (ITT) analysis
In the ITT analysis, functional capacity measures and QOL measures did not differ significantly between treatment groups in both t test on mean ‘‘changes from baseline within subject to the 6-month FU’’ and repeated-measure ANOVA. However, trends of better improvement in functional capacity among the HQG subjects were noted. The mean changes from baseline within subject for the 6MW were 27.25m (standard error [SE]ผ52.26) in the HQG group and 10.65 (SEผ59.43) in
the control group, and those for the MFTE were 1.07 (SEผ3.08) in the HQG group and 0.50 (SEผ1.78) in the control group. Moreover, trends of deterioration in QOL measures were noted in the control group. Four (4) QOL subscales showed negative changes in the mean changes from baseline in the control group, but all QOL subscales showed positive changes in the HQG group.