User Manual Part 4

CLINICAL STUDY - COMPANION
B-33
2.0
1.0
0.5
1.5
0.0
Time (months)
∆ Peak VO
2
(ml/kg/min)
3 6
CRT
OPT
∆ = 0.8
p = 0.026
∆ = 0.6
p = 0.074
(Critical boundary = 0.10)
Mean ± SE
Figure B-13. Maxim a l Oxygen Consumption Results
Table B-11. Maximal Oxygen Consumption Results
CRT OPT
Peak VO
2
(ml/kg/min)
N Mean ±
S.E.
N Mean ±
S.E.
P-value
a
Change a t 3 mont hs
247 1.1 ± 0.2 52 0.3 ± 0.4 0.026
Change a t 6 mont hs
230 1.2 ± 0.2 46 0.6 ± 0.4 0.074
a. P-values obtained using one-tailed longitudinal analysis methods.
The longitudinal analysis was performed on all available data. The percentages
of missing data at the six-month endpoints for Peak VO
2
and Six-Minute Walk
were 36 percent and 28 percent for the CRT arm and 47 percent and 34 percent
for the OPT arm. The longitudinal analysis performed is most appropriate when
missing data occurs at the percentages found in this trial.
Six-Minute Walk––the Six-Minute Walk test is a measure of a patient’s ab ility
to sustain exercise during an activity simila r to that which a patient may typically
perform on a daily basis. For this test, patients are instructed to walk as far as
possible in 6 minutes in a level corridor (Figure B-14 on page B-34, Table B-12
on page B-34).
- DRAFT -