groups, the expected confidence interval for the difference in
the relative number of new bleeding episodes for the two
groups was computed as (0Æ196–0Æ196).
During the course of the study, interim analyses and data
evaluation were performed every second month to ensure that
a continuation of the study was justifiable. Had we found
that participants had suffered more bleeding episodes as a
result of mobilisation, the trial would have been terminated.
Ethics review board approval
The nursing staff, or the doctor in charge of treatment,
received and filed the participants’ written, informed consent.
The trial was approved by the local ethics committee (North
Jutland Ref-No 2006-0015).
Results
During the study period from 3 May 2006–1 April 2008, 105
participants were enrolled, because five participants had to be
excluded after their initial inclusion; in the control group,
three cases were unable to adhere to the bed rest regime, one
case was excluded because of a nurse non-compliance with
the immobilisations regime. In the study group, one case was
excluded, because bed rest was later prescribed for unrelated
medical reasons (Fig. 1). The basic characteristics of the 100
participants, who completed the study course, are displayed
in Table 2. It appears that men are somewhat overrepresented
compared to women, especially in the control group.
Moreover, diabetics appear more frequently in the control
group compared to the study group. In all other relevant
respects, the study and the control groups were similar.
The primary outcomes are depicted in Table 3, where
bleeding episodes are compared. Twenty-one mobilised
participants experienced new bleeding compared with 29
who did not, whereas in the control group, 24 participants
experienced new bleeding compared to 26, who did not. The
odds ratio for bleeding in the mobilised group amounts to
0Æ784 with a confidence interval of (0Æ356–1Æ728). It appears
that there was no significantly increased risk of new bleeding
related to mobilisation compared with immobilisation.
The complications experienced by patients enrolled in the
study are shown in Table 4. The figures are scanty, because