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Seminário 15
Seminário 15
Methods tion. The study was approved by the local Medical Ethics Com-
mittee.
Participants and Study Design Of 183 applications for participation, 70 persons were excluded
Participants were recruited by means of newspaper advertise- for various reasons, mostly because they had not experienced a fall
ments. Participants had to be at least 65 years old and community- or declined participation. Of the 113 participants that were includ-
dwelling. In addition, they should have experienced at least one fall ed in the study, the first 49 persons were directly assigned to the
in the year prior to participation and be able to walk 15 min with- exercise program (EX1). Of the other 64 participants, 6 persons
out the use of a walking aid. The exclusion criteria were severe car- dropped out before randomization for medical (n = 2) or social
diac, pulmonary or musculoskeletal disorders, pathologies associ- (n = 4) reasons. The remaining 58 participants were randomly as-
ated to increased fall risk (i.e. stroke or Parkinson’s disease), osteo- signed to the exercise program (EX2) (n = 30) or to the control group
porosis, and the use of psychotropic drugs. These criteria were (CON) (n = 28). After randomization, the post-intervention pos-
checked by self-report. Table 1 includes some group characteristics turographic and obstacle avoidance assessments could not be con-
at baseline. All subjects gave informed consent prior to participa- ducted for 1 participant in the EX2 group due to acute knee com-
plaints (unrelated to the intervention) and for 2 participants in the cated to balance, gait, and coordination training in an obstacle
CON group, 1 person due to intestinal complaints and 1 person course, which mimics activities of daily life with potential fall risk.
refused the assessments. Figure 1 provides a detailed overview of Some examples of the elements in the obstacle course are walking
the study’s chronology, also of the EX1 group. over doorsteps, stepping stones, uneven pavement, and over vari-
ous kinds of ground surface. Reaching from a stool, standing up
Procedure from a low chair without use of the arms, and making a transfer
After inclusion, a median baseline period of 6 months (mean from stance to a kneeling position were also components of the bal-
5.89 months, SD 2.21 months) started during which individual fall ance and coordination training. To simulate the complexity of dai-
incidence was monitored. Thereafter, just before group assignment ly life, the balance and gait tasks had to be performed simultane-
and randomization, a number of laboratory assessments of balance ously with various additional motor and cognitive tasks (25 and
and obstacle avoidance took place. In addition, all participants re- 20% of the time, respectively) and under visual constraints (15% of
ceived the Activities Specific Balance Confidence Scale (ABC) [12] the time). Motor dual tasks were carrying a tray with empty cups,
to be completed at home. Within the following 4 weeks, those sub- carrying grocery bags or an umbrella. As a concurrent cognitive
jects assigned to the experimental intervention started the 5-week task, for instance, a story was told that had to be reproduced as well
exercise program. The other (control) subjects did not receive any as possible after the participants had finished the obstacle course.
specific treatment. For all participants, the laboratory assessments A visual constraint was, for example, carrying a tray in front of the
and completion of the ABC were repeated within the 4 weeks fol- abdomen taking away the sight of the feet. During all the exercises,
lowing the exercise program or within 5–9 weeks from the moment that closely resembled activities of daily life, participants not only
of group assignment. Fall incidence was monitored during a 7- practiced difficult situations, but they also learned to recognize and
month follow-up period from the moment of group assignment. cope with potentially hazardous situations.
The second session of the week consisted of two elements. The
Exercise Program first element was formed by a number of walking exercises that
The 5-week exercise program consisted of 10 sessions (2 ses- simulated walking in a crowded environment with many changes
sions/week) of 1.5 h each. The first session of the week was dedi- in speed and direction. The second element was based on the prac-
Exercise group
Number of falls 55 43
Observation time, person-years 31.1 45.4
Fall incidence rate, falls/person-years 1.77 0.95a 0.54 (0.36–0.79)
Number (%) of fallers 35 (58) 31 (40)b 0.61 (0.38–0.98)
Control group
Number of falls 21 29
Observation time, person-years 11.8 16.6
Fall incidence rate, falls/person-years 1.77 1.75a 0.98 (0.56–1.72)
Number (%) of fallers 9 (32) 9 (32)b 0.71 (0.28–1.78)
a
IRR exercise group compared to control group 0.54 (95% CI 0.34–0.86).
b
IRR exercise group compared to control group 1.26 (95% CI 0.60–2.64).
ways avoid the obstacle. Failures were defined as contact of the foot Results
with the obstacle and were noted during the experiment. In case of
doubt, the video recordings were used to judge whether a trial was Baseline Group Characteristics and Exercise Sessions
successful or not. Afterwards, for each trial the resultant ART was
calculated (see Weerdesteyn et al. [20]). The ART was defined as
Attendance
the time span between obstacle release and the moment that the The three groups were comparable with respect to age,
hallux would cross the front of the obstacle when no avoidance re- gender, drug use, posturographic assessment, timed one-
action would occur. Trials were subdivided into ART categories of leg stance, balance confidence scores and obstacle avoid-
200–250, 250–300, 300–350 ms, and 1350 ms. For each partici- ance performance at baseline (see table 1). Despite ran-
pant, success rates were calculated for each ART category by divid-
ing the number of successful trials by the total number of trials in domization, the proportion of fallers in the control group
that ART category. was significantly smaller than in the EX2 group (p =
0.034), but fall incidence rates showed no differences be-
Statistical Analysis tween the groups. There was no baseline group difference
First, it was planned to determine whether there were any pre- in falls monitoring time, so this could not explain the
test differences on any of the outcome measures between the groups smaller proportion of fallers in the CON group. There
(EX1, EX2, and CON) by means of one-way ANOVAs, with post-
hoc Bonferroni corrections. When no differences would be present
were no significant differences between the EX1 and the
between the EX1 and EX2 groups, further analyses could be con- EX2 group for either the proportion of fallers or the fall
ducted with the results of these experimental groups combined ver- incidence rate. Hence, in the statistical analyses the re-
sus the control group on an intention-to-treat basis. sults of both exercise groups were combined. The mean
Fall data were analyzed with respect to total number of falls and attendance rate to the exercise sessions was 87% for both
the number of fallers (participants with at least one fall). Falls
incidence rates (IR) during baseline and follow-up periods were
groups. Of all participants, 51% attended the maximum
calculated by dividing the total number of falls by the total num- number of 10 sessions.
ber of person-years. To compare the fall incidence rates between
groups or between periods of time, a fall incidence rate ratio (IRR) Falls
was calculated. The same was done to compare the incidence of During the baseline period, there was 1 participant
fallers.
Repeated measures MANOVAs were conducted to compare
with 12 falls in the exercise group and 1 subject with 8
changes in balance confidence and balance and obstacle avoidance falls in the control group. To avoid overweighting of these
performance, with Time (all analyses), Condition (analysis of quiet participants, only the first 6 falls per person per period
stance and weight-shifting) and ART (analysis of obstacle avoid- were included in the analyses of the total numbers of falls.
ance) as within subject factors and Group as a between-subjects The calculated fall incidences are presented in table 2. In
factor. The levels were 0.05. Post-hoc paired t tests were used to
assess which of the conditions or ART categories showed significant the exercise group, the falls IR decreased from 1.77 falls
differences. levels of 0.05 were corrected for the number of post- per person-year during the baseline period to 0.95 falls
hoc tests per analysis per group. per person-year during the follow-up period (falls IRR
0.54, 95% CI 0.36–0.79). In the control group, the falls The proportion of fallers in the exercise group decreased
IR was 1.77 falls per person-year during the baseline pe- from 58% during the baseline period to 40% during the
riod and 1.75 falls per person-year during the follow-up follow-up period (fallers IRR 0.61, 95% CI 0.38–0.98),
period (falls IRR 0.98, 95% CI 0.56–1.72). Comparing whereas the proportion of fallers in the control group
the follow-up falls IR between the exercise group and the (32%) did not change. Because the proportion of fallers
control group, the falls IRR was 0.54 (95% CI 0.34–0.86). in the exercise group was larger than in the control group
during the baseline period, this reduction in the propor- on both weight-shifting tasks, whereas the control group
tion of fallers did not result in a significant difference be- only improved the number of weight shifts made with
tween exercise and control group during the follow-up visual feedback by 15%. Analysis of timed one-leg stance
period. yielded a main effect of Time (F(1,99) = 14.336, p !
0.001), but no Time ! Group interaction (F(1,99) =
Balance Tasks 0.127, p = 0.722) (see table 3). Post-hoc analyses showed
Pre- and post-intervention balance data were available that both exercise and control groups showed 12–16%
for 101 participants. Table 3 shows means and SDs of improvement at the second assessment.
balance and balance confidence measures for the exercise
and the control group. In this table, only the RMS COP Balance Confidence
velocities are presented but RMS COP amplitudes showed Six participants did not complete the ABC question-
a similar pattern of results and significance. Analysis of naire correctly or did not return it, so that pre- and post-
the RMS COP velocities during quiet stance revealed a intervention ABC scores were available for 95 partici-
significant Time ! Group interaction (F(1,95) = 4.424, pants. Seven items were deleted based on baseline assess-
p = 0.038), but no significant main effect of Time (F(1,95) ment. Analysis of balance confidence scores revealed a
= 0.404, p = 0.527). Post-hoc analyses showed that the significant Time ! Group interaction (F(1,93) = 4.18,
exercise group showed no significant difference between p = 0.044). At the end of the program, balance confidence
pre- and post-intervention assessments, whereas the con- had improved by 6% in the exercise groups, whereas the
trol group showed a 12% increase in the RMS COP veloc- control group showed an insignificant (2%) deterioration
ity in the anterior-posterior direction while standing on across time (see table 3).
the normal surface with eyes open condition as well as a
14% decrease in the RMS COP velocity in this direction Obstacle Avoidance Task
while standing on the compliant surface with eyes closed. Six participants were not capable of performing the
Analysis of the number of weight shifts yielded a signifi- obstacle avoidance task, so that obstacle avoidance data
cant main effect of Time (F(1,98) = 13.623, p ! 0.001), were available for 95 participants. Obstacle avoidance
but no significant Time ! Group interaction (F(1,98) = success rates are shown in figure 2. There was a significant
0.300, p = 0.585). The exercise group improved 8–15% main effect of Time on obstacle avoidance success rates
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