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What is This?
CLINICAL
Article REHABILITATION
Clinical Rehabilitation
controlled trial
Abstract
Objective: To investigate the effects of a physiotherapy protocol on patients with pleural effusion.
Design: Randomized controlled trial.
Setting: University hospital.
Participants: A total of 104 consecutive inpatients with a medical diagnosis of pleural effusion.
Intervention: Patients were randomly allocated to a control group receiving standard treatment (medical
treatment and drainage) or an intervention group treated with physiotherapy added to standard treatment.
The physiotherapy programme included deep breathing exercises, mobilizations and incentive spirometry.
Main outcome measures: Spirometric predicted values and chest radiographs were measured before
treatment and at discharge and the length of hospital stay was recorded. Assessors were blinded to the
intervention.
Results: A comparative analysis showed a significant improvement of spirometric parameters in the
intervention group; pre-to-post hospitalization predicted values showed significant changes in vital capacity
(73.1 ± 12.6% to 72.13 ± 13.7 %, P<0.001 ), forced expiratory volume in first second (72.13 ± 13.7% to
78.98 ± 16.9%, P<0.001) and forced expiratory flow at 25-75 % (64.8 ± 35.1% to 76.78 ± 35.3%, P=0.198)
compared to the control group that showed no significant changes across treatment. The radiographic
findings showed better scores on the affected side of the thorax at discharge in the physiotherapy group.
Length of hospital stay was also significantly (P=0.014) shorter in the intervention group (26.7 ± 8.8 days)
compared to the control group (38.6 ± 10.7 days).
Conclusions: A physiotherapy programme added to standard treatment improves the spirometric
parameters and the radiological findings and reduces the hospital stay in patients with a pleural effusion.
Keywords
Pleural effusion, physiotherapy, length of stay, spirometry
Excluded (n= 8 )
Not meeting inclusion criteria (n= 6 )
Declined to participate (n= 0 )
Other reasons (n= 2 )
Assessments:
Allocation
Allocated to PT Group (n= 52 ) Allocated to n-PT Group (n= 52 )
Received allocated intervention (n= 52 ) Received allocated intervention (n= 49 )
Did not complete the intervention (n= 3 )
Reason: decided not to continue (n=1)
Complications (n=2)
and analysis
Figure 1. Flow diagram representing the recruitment, inclusion, assignment and subsequent follow-up of the study
patients.
the study, after which they gave their informed process. The randomization sequence was drawn
written consent to participate. up and kept off-site by an independent body, using
Patients were randomized to the intervention a random number generator in blocks of eight with
group (physical therapy added to standard treat- no stratification. The sequence of subjects included
ment) or to the control group (medical treatment in every treatment group was mailed from the inde-
and drainage). To ensure concealment of alloca- pendent body to the recruiter. The design of the
tion, eligibility was determined by a blinded asses- study and participants’ distribution between groups
sor (a nurse) not involved in the randomization is shown in Figure 1.11
After the allocation, baseline measures were more than eight years of experience graded the
taken. All the data were collected by an independ- pleural effusion severity from 0 (no pleural effu-
ent researcher who was blinded to the allocation sion) to 10 (massive pleural effusion).
group of the patients.
The assessment included a complete clinical
Length of hospital stay
history review and a physical examination.
The outcome measures recorded were the Length of hospital stay (LOS) is defined as the
spirometry and the chest radiograph at baseline and number of days between hospital admission and
at discharge and the length of hospital stay. discharge. Over recent years, LOS has been shown
to be an outcome variable in several therapeutic
strategies and practical guidelines.19
Spirometry All the patients included in the study received
Spirometry was used to assess the severity of indi- standard treatment. This was based on medical
vidual patients’ respiratory disease and their treatment including management and clinical care,
response to therapy.12 It is regarded as the gold pharmacologist approach and drainage (if neces-
standard measure of respiratory function.13 A sary) during the hospital stay.
Medical International Research (MIR) Spirolab II Patients allocated in the intervention group
spirometer was used to collect data using Knudson received physiotherapy added to standard treat-
et al.14 predicted spirometric values as the normal ment. The physiotherapy programme started when
reference values. The following variables were the patient was considered clinically stable by the
recorded: 1) forced vital capacity (FVC), 2) forced medical doctor. A trained physiotherapist provided
expiratory volume achieved in the first second 40–60 minute sessions five times per week during
(FEV1), and 3) forced expiratory flow at 25 -75 % the hospital stay. The physiotherapy protocol was
(FEF25-75). These variables were calculated supervised and individually adapted, according to
according to the methods defined in the Medical the patient response to treatment. Patients were
International Research manual.15 monitored during the exercise performance in
order to detect increased pain, severe dyspnea,
desaturation and/or increased skin temperature at
Chest radiographs each session.
Posteroanterior and lateral chest radiographs The physiotherapy protocol included mobiliza-
were used to confirm the diagnosis at baseline tion techniques and exercises, deep breathing exer-
and as an outcome measure of severity. Lateral cises and incentive spirometry. The proposed
radiographs are able to identify a small amount of exercises have been reported to increase strength,
fluid. The diagnosis criteria was based on some flexibility, and range of motion.20,21
radiological findings including the following fea-
tures: on the lateral chest radiograph, pleural
Mobilization techniques and
effusions became visible as a meniscus at a vol-
ume of approximately 50 ml.16 At a volume of exercises
200 ml, the meniscus is also identified on the Limb exercises (i.e., passive, active assisted, or
posteroanterior radiograph and at a volume of active) were performed in bed or in a seated posi-
about 500 ml the hemidiaphragm appear to be tion, depending on medical advice, with the aim of
obscured. Other radiologic findings are blunting maintaining joint range of motion, improving soft-
of the costophrenic angle and in case of a large tissue length, muscle strength and function, and
volume of fluid a mediastinal shift could be decreasing the risk of thromboembolism. The deep
appreciated.17 breathing programme included pursed lips breath-
The severity was scored using a numeric scale ing, active expiration and incentive spirometry, as
as shown in previous studies.18 A radiologist with follows:
•• Pursed lips breathing: Pursed lips breathing was used to perform such comparisons with non-
works to improve expiration, requiring active parametric data. Differences between groups were
and prolonged expiration and to prevent airway analyzed with the independent t-test for parametric
collapse.22 It has been found to have a more data and the Mann-Whitney U-test for non-para-
marked increase of tidal volume and a decrease metric data. The alpha level was set at 0.05.
of breathing frequency.23
•• Active expiration: The active expiration length-
Results
ens the diaphragm and contributes to make it
operate close to its optimal length.24,25 In addi- A total of 112 patients who fulfilled the criteria
tion, active expiration increases elastic recoil for pleural effusion were included in the study.
pressure of the diaphragm and the rib cage.25 Finally, a total of 104 patients were enrolled and
•• Incentive spirometry: Incentive spirometry was randomly assigned to the intervention or to the
used as a lung expansion therapy, and it was control group. Figure 111 shows the recruitment,
administered supervised by a physiotherapist inclusion, assignment, and subsequent follow-up
during 10 to 15 minutes per day.26,27 The device of the patients.
used was the Coach spirometer (Kendall; Demographic and clinical data for the study
Neustadt, Germany) groups are shown in Table 1. No significant differ-
ences between-groups were found for any of the
The inpatients allocated to the control group did variables. Most participants had left side and exu-
not receive any physiotherapy. They received only date pleural effusion (Table 1).
the standard treatment. No significant differences were found between
Sample size calculation was based on the pri- the two groups for the dependant variables of
mary outcomes: spirometry results and radio- severity and the spirometric values at baseline.
graphic score. An increase in FVC and FEV1 (Table 1).
(-12±3.3 and -15±8.2) was expected in the control Table 2 shows the outcome measures (radio-
group, as previously reported28 and a greater posi- graphic pleural effusion score, spirometric values
tive effect (-3 in FVC and -5 in FEV1) was antici- and length of hospital stay) at baseline and at
pated in the intervention group. discharge.
Hence, in order to have 80% power using a two- The intervention group showed a significant
sided α=0.05 and a hypothetical dropout rate of pre-to-post hospital stay improvement (P<0.001)
10%, 48 patients in each group were required to in spirometric values (FVC and FEV1) and in
show statistically significant differences between radiographic severity. Student’s t-test showed a
both groups in FVC and FEV1. significant difference between groups in length of
Data were entered into Statistical Package for hospital stay, being shorter in the physiotherapy
the Social Sciences, version 20.0 (SPSS Inc., group.
Chicago, IL, USA) for analysis. Descriptive statis-
tics (mean ± standard deviation) were used to
Discussion
determine participant characteristics. Prior to sta-
tistical analysis, the Kolmogorov-Smirnov test was The objective of this study was to investigate the
performed to assess the normality of continuous effects of a respiratory physical therapy programme
data. The statistical distribution of the data was ini- added to standard treatment on spirometric param-
tially analyzed using the Shapiro Wilks test. The eters, chest radiographs and length of hospital stay
demographic data and initial assessment results in inpatients with a pleural effusion.
were compared using the Student’s t-test. The t-test Our results show greater improvement in all the
for paired samples was used to compare the results variables measured in the physiotherapy interven-
of the assessment before and after treatment for tion group. More specifically, this group improved
parametric data. The Wilcoxon signed rank test the pulmonary function, decreased the severity and
FVC %: predicted forced vital capacity, FEV1%: predicted forced expiratory volume in first second, FEF25-75: forced expiratory flow
25%-75%, SD: standard deviation, BMI: body mass index, n: number of subjects allocated in a group.
the length of hospital stay was shorter compared effusion regardless of the etiology. In fact, various
with the control group. studies33,34 have suggested that patients with pleu-
Several studies have shown physical therapy to ral effusion should be included in a respiratory
be effective in the treatment of various respiratory physiotherapy programme as early as possible. Yet,
conditions.9,10,29,30 The general aim of a physiother- to our knowledge, no clinical trials focused on the
apy programme in critical areas is to apply effects of a physiotherapy programme in hospital-
advanced and cost-effective therapeutic modali- ized patients due to a pleural effusion are available
ties, decrease the dependence of patients, improve in the literature.
residual function, reduce the risk of new hospitali- One of the most important goals of physical ther-
zation and improve the quality of life.31 apy related to hospitalization due to respiratory
Physiotherapy has been proposed by some pathologies, even in highly compromised patients is
authors32-34 as part of the treatment of a pleural to enhance their functional capacity and to decrease
Between groups
FVC: forced vital capacity, FEV1: forced expiratory volume in first second, FEF25-75: forced expiratory flow 25%-75%, LOS: length of hospital stay, n: number of subjects allocated in a group, CI: confi-
rest.35 In order to that, we included mobilization
techniques and exercises to reduce the musculo-
P-value
skeletal complications due to the bed rest, and res-
0.001
0.198
0.001
0.042
0.014
piratory exercises to improve respiratory function.
The standard treatment includes drainage of the
Within group
0.062
0.952
0.114
0.221
static lung volumes which were lower than the vol-
–
ume of fluid removed.23,35 This indicates that pleural
3.04 (–0.76, 6.80)
0.068 (–2.3, 2.2)
Mean difference
38.6±10.7
Post-
from 17 to 37 days.37-39
Ferguson et al.37 analyzed 119 patients with
26.7 ± 8.8 –
4.84 ± 1.73
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