Physiotherapy Theory and Practice

An International Journal of Physical Therapy

ISSN: 0959-3985 (Print) 1532-5040 (Online) Journal homepage: https://www.tandfonline.com/loi/iptp20

Which ICU patients benefit most from inspiratory

muscle training? Retrospective analysis of a
randomized trial

Bernie M Bissett PhD, Jiali Wang MSc, Teresa Neeman PhD, I Anne Leditschke
MBBS, Robert Boots PhD & Jennifer Paratz PhD

To cite this article: Bernie M Bissett PhD, Jiali Wang MSc, Teresa Neeman PhD, I Anne
Leditschke MBBS, Robert Boots PhD & Jennifer Paratz PhD (2019): Which ICU patients benefit
most from inspiratory muscle training? Retrospective analysis of a randomized trial, Physiotherapy
Theory and Practice, DOI: 10.1080/09593985.2019.1571144

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Published online: 09 Feb 2019.

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PHYSIOTHERAPY THEORY AND PRACTICE
https://doi.org/10.1080/09593985.2019.1571144

Which ICU patients benefit most from inspiratory muscle training? Retrospective
analysis of a randomized trial
Bernie M Bissett PhDa,b, Jiali Wang MScc, Teresa Neeman PhDc, I Anne Leditschke MBBSd,e, Robert Boots PhDf,g,
and Jennifer Paratz PhDf,g,h
a
Discipline of Physiotherapy, University of Canberra, Canberra, Australia; bPhysiotherapy Department, Canberra Hospital, Canberra, Australia;
c
Statistical Consulting Unit, Australian National University, Canberra, Australia; dIntensive Care Unit, Mater Hospital, Brisbane, Australia;
e
Mater Research Institute, University of Queensland, Brisbane, Australia; fIntensive Care Unit, Royal Brisbane and Women’s Hospital, Brisbane,
Australia; gSchool of Medicine, University of Queensland, Brisbane, Australia; hSchool of Health Sciences, Griffith University, Gold Coast,
Australia

ABSTRACT ARTICLE HISTORY

Background: Inspiratory muscle training (IMT) increases inspiratory muscle strength and improves Received 29 August 2018
quality of life in intensive care unit (ICU) patients who have been invasively mechanically Revised 17 November 2018
ventilated for ≥7 days. The purpose of this study was to identify which patients benefit most Accepted 10 January 2019
from IMT following weaning from mechanical ventilation. KEYWORDS
Methods: Secondary analysis of a randomized trial of supervised daily IMT in 70 patients (mean Physiotherapy techniques;
age 59 years) in a 31-bed ICU was carried out. Changes in inspiratory muscle strength (maximum breathing exercises; critical
inspiratory pressure, MIP) between enrolment and 2 weeks (ΔMIP) were analyzed to compare the care; intensive care
IMT group (71% male) and the control group (58% male). Linear regression models explored
which factors at baseline were associated with ΔMIP.
Results: Thirty-four participants were allocated to the IMT group where baseline MIP was
associated with an increase in ΔMIP, significantly different from the control group (p = 0.025).
The highest ΔMIP was associated with baseline MIP ≥ 28 cmH2O. In the IMT group, higher baseline
quality of life (EQ5D) scores were associated with positive ΔMIP, significantly different from the
control group (p = 0.029), with largest ΔMIP for those with EQ5D ≥ 40.
Conclusions: Physiotherapists should target ICU patients with moderate inspiratory muscle
weakness (MIP ≥28 cmH2O) and moderate to high quality of life (EQ5D>40) within 48 h of
ventilatory weaning as ideal candidates for IMT following prolonged mechanical ventilation.

Introduction Physiotherapists are now exploring inspiratory muscle

training (IMT) as a strategy to reverse inspiratory muscle
Patients in the intensive care unit (ICU) who experi-
weakness in ICU patients. A recent systematic review found
ence invasive mechanical ventilation for more than
that IMT is feasible in ICU patients, and while a wide variety
72 h are susceptible to inspiratory muscle weakness
of techniques have been used, the most common approach
(Dres et al., 2017; Levine et al., 2008). In patients
is threshold loading (Vorona et al., 2018). Threshold IMT
invasively ventilated for longer than 7 days, this weak-
requires the patient to inhale against a device which provides
ness manifests as impairments in both inspiratory mus-
a titratable training resistance. In the ICU, this training is
cle strength and endurance soon after ventilatory
supervised by a physiotherapist who can attach the device to
weaning (Bissett et al., 2015). These impairments may
an endotracheal tube or tracheostomy, if necessary (Bissett
contribute to elevated dyspnea in ICU patients both at
and Leditschke, 2007). IMT is safe and feasible in selected
rest and during exercise (Bissett et al., 2015) and thus
ventilator-dependent patients (Bissett, Leditschke, and
hamper functional recovery. As ICU survivors often
Green, 2012), and improves inspiratory muscle strength
have poor levels of physical function (Herridge et al.,
while increasing the likelihood of successful weaning from
2015, 2011; Iwashyna, Ely, Smith, and Langa, 2010;
the ventilator (Elkins and Dentice, 2015). However, the
Rydingsward et al., 2016) and poor quality of life
requirement for alertness during training (Bissett,
(Cuthbertson et al., 2010), interventions which improve
Leditschke, Paratz, and Boots, 2012) means that many
strength and quality of life should be a priority for the
patients cannot actively participate in IMT during the
healthcare team.

CONTACT Bernie Bissett Bernie.Bissett@canberra.edu.au Discipline of Physiotherapy, University of Canberra, Bruce, A.C.T. 2617, Australia
Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/iptp.
© 2019 Taylor & Francis Group, LLC
2 B. M. BISSETT ET AL.

ventilator-dependent phase (e.g., due to sedation or delir-
ium). Thus, IMT may not be feasible for many patients until
they are weaned from mechanical ventilation.
In 2016, we published the first randomized trial of IMT
in ICU patients in the postweaning phase of recovery
(Bissett et al, 2016b). This study demonstrated that, in
patients who had been invasively ventilated for 7 days or
longer, those who participated in daily IMT for 2 weeks
following successful weaning increased their inspiratory
muscle strength (mean difference 11% of predicted max-
imum inspiratory pressure (MIP). Furthermore, those who
trained their inspiratory muscles had greater improvements
in quality of life scores (mean difference 12% on the EQ5D
scale). However, our primary analysis grouped all respon-
ders together and given the heterogeneity of the response to
training, we sought to further scrutinize the data to gain
some insights into which patients are most likely to benefit
from IMT in the postweaning period, in order to guide
physiotherapists in prioritizing and optimizing treatment
for ICU survivors. Thus, in patients who have been recently
weaned from invasive mechanical ventilation of 7 days’
duration or longer, the research questions we sought to
answer were (1) Which patients are likely to benefit most
from IMT in terms of change in inspiratory muscle
strength? and (2) Can any factors measured at the point of
ventilatory weaning (within 48 h) predict improvements in
inspiratory strength with 2 weeks of daily IMT?
conducted using a threshold device with a training range of
9–41 cmH2O. Intensity was increased daily such that the
patient could just complete the sixth breath in each set.
Where necessary, the IMT device was connected to the
patient’s tracheostomy if this was still in situ, using
a connector (Figure 1), and training performed with the
tracheostomy cuff inflated. Otherwise, training was per-
formed through a mouthpiece with a noseclip in situ. IMT
was commenced in ICU and continued into the ward for
2 weeks. Both groups continued to receive usual physiother-
apy interventions (including mobilization, airway clearance
techniques, and exercise).
Outcomes
Primary outcome
For the purpose of this secondary analysis, we created
a new primary measure of change in maximum inspira-
tory pressure (ΔMIP), where ΔMIP equals the difference
between MIP measured at the end of the study and MIP
on enrolment (where MIP is expressed as a % of predicted
values). MIP was measured by research nurses, blinded to
group allocation, using a standardized protocol recom-
mended in the American Thoracic Society/European
Respiratory Society guidelines (ATS, 2002). MIP was
measured using a handheld respiratory pressure meter

Materials and methods

Design, setting, and participants
This study was a retrospective analysis of results of
a randomized trial which has been fully described pre-
viously (Bissett et al., 2016b). This trial was a single-
center study, in a 31-bed mixed surgical/medical/
trauma ICU, comparing daily supervised threshold
IMT with usual care over a 2-week period in ICU
patients who had been invasively ventilated for 7 days
or longer. The patients needed to be alert and able to
cooperate with training and follow instructions.
Patients provided their own written consent. The
study used concealed allocation and blinded outcome
assessors and was approved by ACT Health Human
Research Ethics Committee, and University of
Queensland Human Research Ethics Committee.

Intervention
The IMT protocol has been described previously in detail
(Bissett, Leditschke, Paratz, and Boots, 2012; Bissett et al,
2016b). A physiotherapist supervised five sets of six breaths Figure 1. Attachment of IMT device to tracheostomy via
at an intensity which was at least 50% of MIP. IMT was connector.
 PHYSIOTHERAPY THEORY AND PRACTICE 3

which has excellent reliability in non-ventilated partici- patients in the both treatment and control groups was
pants(Intraclass Correlation Coefficient (ICC) 0.83–0.90) 59 years, with 71% male in the treatment group and
(Dimitriadis et al., 2011). 58% male in the control group. Mean APACHE II
scores were 20 and 23, respectively. Sepsis and multi-
Secondary outcomes (factors) trauma were the most common diagnoses, and mean
Measures available at baseline (prior to group alloca- duration of mechanical ventilation was 11 days in the
tion) were treated as factors in this analysis. Baseline treatment group and 10 days in the control group. In
MIP was measured as described above in cmH2 the treatment group, compliance with the intervention
O. Quality of life was measured by research nurses was 85% and no adverse effects were reported during or
using the EQ5D-3L tool (under license EuroQol immediately after the training.
International) which has been used in other studies of
ICU survivors (Granja, Teixeira-Pinto, and Costa-
Analysis of factors associated with changes in
Pereira, 2002). Physical function was calculated by the
inspiratory muscle strength
treating physiotherapist using the Acute Care Index of
Function (ACIF) tool (Roach and Van Dillen, 1988; The results of the regression analysis are presented in
Van Dillen and Roach, 1988), whereby a score of 1.00 Table 1. Treatment group was a significant factor for
indicates completely independent physical function, ΔMIP (p = 0.006). In the treatment group, baseline MIP
and a score of 0.00 represents a patient who requires was significantly associated with ΔMIP, and this was
complete assistance even to roll over in bed. The ACIF different from the control group (p = 0.025). In the
tool has excellent inter-rater reliability and validity in treatment group, positive ΔMIP scores were most com-
ICU patients (Bissett et al., 2016a). monly observed where baseline MIP was greater than
28 cmH2O (Figure 2). Similarly, in the treatment group,
baseline EQ5D scores were associated with positive
Data analysis ΔMIP scores, which was significantly different from
The dependent variable was defined as ΔMIP (MIP the control group (p = 0.029). For EQ5D scores, the
completion − MIP enrolment.). Linear regression mod- most positive ΔMIP scores occurred in patients whose
els were used to assess which factors at baseline were baseline EQ5D scores were 40 or higher (Figure 3).
significantly associated with ΔMIP scores. Factors The relationship between baseline MIP and EQ5D
included age, sex, disease severity (APACHE II), base- scores and ΔMIP is further described in Table 2. For
line functional score (ACIF), baseline quality of life example, a patient with a baseline MIP of 19 cmH2
score (EQ5D), and treatment group (IMT group or O who completed 2 weeks of IMT typically increased
control). Interaction terms were also included in the MIP by only 8% (noting 95% confidence interval [CI]
model (treatment group × APACHE II, treatment −1, 18), which is not different from a patient who
group × baseline MIP, treatment group × baseline
ACIF, treatment group × baseline EQ5D) to test the Table 1. Regression analysis for ΔMIP in patients undergoing
differences of the associations between the secondary inspiratory muscle training (treatment) or usual care following
outcomes and ΔMIP in the treatment group and con- ventilatory weaning.
trol group. Two-sided tests were considered statistically Regression analysis
significant where p < 0.05. Statistical analyses were Coefficient (95% confidence
Factor interval) p-Value
conducted using Statistical Packaging for the Social Age 0.000 (−0.003, 0.003) 0.819
Sciences (SPSS 23, IBM Corporation, NY, USA) and Sex (female) −0.041 (−0.134, 0.053) 0.391
Treatment group −0.543 (−0.931, −0.155) 0.006**
R Statistical Package (R Foundation for Statistical Disease severity (APACHE II) 0.000 (−.007, 0.007) 0.909
Computing, Vienna, Austria)(version 3.0.2). Baseline MIP score −.001 (−0.005, 0.003) 0.542
Baseline ACIF score −0.291 (−0.587, 0.004) 0.053
Baseline EQ5D score 0.000 (−0.002, 0.003) 0.855
APACHE II × treatment 0.005 (−0.005, 0.016) 0.327
Results group
Baseline MIP × treatment 0.006 (0.001, 0.010) 0.025*
Participant characteristics group
Baseline ACIF × treatment 0.407 (−0.066, 0.881) 0.091
group
The participant characteristics and flow of participants Baseline EQ5D × treatment 0.004 (0.000, 0.008) 0.029*
have been published previously (Bissett et al., 2016b). group
Thirty-four patients were allocated to the treatment MIP = maximum inspiratory pressure; APACHE = Acute Physiology and
Chronic Health Evaluation tool; EQ5D = quality of life tool;
group and 36 to the control group, with a loss to ACIF = Acute Care Index of Function.
follow-up of six in each group. The mean age of *p < 0.05, **p < 0.01; ***p < 0.001.
4 B. M. BISSETT ET AL.

Figure 2. Changes in inspiratory muscle strength (ΔMIP) rela- Figure 4. Changes in inspiratory muscle strength (ΔMIP) rela-
tive to baseline inspiratory muscle strength (MIP) scores, com- tive to baseline physical function (ACIF) scores, comparing
paring treatment (IMT) and control groups. treatment (IMT) and control groups.

care decreased their MIP (−1%, noting 95% CI −10, 9).

In terms of baseline EQ5D scores, patients with a score
above 40% demonstrated a higher ΔMIP in those who
completed 2 weeks of IMT compared to those receiving
usual care (30% vs. 5%).
While functional scores (ACIF) on enrolment
appeared to favor the treatment group for ΔMIP (Figure
4), this was not statistically significant between groups
(p = 0.091). Neither age, disease severity, nor sex were
significantly associated with ΔMIP in any of the analyses.

Figure 3. Changes in inspiratory muscle strength (ΔMIP) rela- Discussion

tive to baseline quality of life (EQ5D) scores, comparing treat- In this study, we have shown that the patients who are
ment (IMT) and control groups.
most likely to derive a respiratory muscle strength
benefit from IMT are those with moderate inspiratory
received usual care (11%, 95% CI 2, 30). In contrast, muscle weakness (MIP ≥28 cmH2O), and/or moderate
a patient with a baseline MIP of 53 mH2O who com- to high quality of life scores (>40 on EQ5D scale) at the
pleted 2 weeks of IMT typically increased MIP by 21% point of ventilatory independence. While larger studies
(95% CI 13, 29), whereas a patient who received usual are needed to confirm these findings, in the short term,
these data may be useful to physiotherapists in identi-
fying patients who are most likely to respond to a short
Table 2. Mean magnitude of improvement in MIP with 2 weeks course of IMT.
of postweaning inspiratory muscle training or usual care.
It is worth noting that age, sex, disease severity, and
Factor Inspiratory muscle training Control
group group physical function were not associated with improve-
Quartiles
Mean increase ΔMIP [% predicted] ments in inspiratory muscle strength. This may be
(95% confidence interval) a consequence of the small sample size, and larger
Baseline MIP Value studies may shed more light on these variables and
(cmH2O)
20% 19 8 (−1, 18) 11 (2, 30) their relationship to inspiratory muscle strengthening.
40% 28 12 (4, 20) 1 (1, 15) Meanwhile, based on our data, clinicians should con-
60% 38 16 (9, 23) 4 (−2, 11)
80% 53 21 (13, 29) −1 (−10, 9) sider IMT in both male and female patients of all ages.
Baseline EQ5D Value (%) Furthermore, disease severity on admission should not
score
20% 20 8 (−1,18) 9 (−2, 20) deter clinicians from considering IMT for a patient
40% 40 17 (10, 24) 7 (0.14) following 7 days of mechanical ventilation. We spec-
60% 50 21 (13, 29) 6 (0, 13)
80% 72 30 (17, 42) 5 (−4, 13) ulate that it is the interaction of duration of mechanical
MIP = maximum inspiratory pressure; EQ5D = quality of life tool. ventilation (and subsequent inspiratory muscle

weakness), and the patient’s quality of life and will-
ingness to participate in training, which is far more
likely to predict success with IMT. Although arguably
difficult to quantify, this interaction would be valuable
to examine in future studies.
An important limitation of this analysis is that the
IMT device used in this study had a limited training
range. Patients who failed to improve their ΔMIP
scores at the lowest end of the spectrum may have
struggled to open the valve of the device at its lowest
setting (9 cmH2O) as this would have been well in
excess of 50% of their MIP. Thus, the spring-loaded
training device is not ideal for patients at the lowest end
of the inspiratory strength spectrum. Future studies
should explore whether electronic inspiratory muscle
trainers (Tonella et al., 2017) (capable of training at
1 cmH2O) may provide more optimal training for the
weakest ICU patients in the postweaning period, and
particularly with respect to the magnitude of changes in
MIP observed in the first 2 weeks. Furthermore, this
study has only focused on the first 2 weeks following
ventilatory weaning. This analysis may underestimate
the benefits of IMT in the longer term, and a more
realistic training regime (e.g., 6 weeks or longer) should
be explored to better guide clinicians about ideal train-
ing methods.
To apply our findings in practice, clinicians need to
be aware of patients’ inspiratory muscle strength imme-
diately following ventilatory weaning; however, mea-
surement of MIP is not yet standard practice. One
barrier to MIP measurement may be the availability of
a respiratory pressure meter. However, new electronic
inspiratory muscle trainers provide MIP measurement
as a feature, and this has been shown to be a reliable
method of measuring MIP in patients with acute stroke
(Lee, Kim, Jeong, and Lee, 2016). Adoption of this
technology in the ICU may reduce barriers to identifi-
cation and training of suitable patients for IMT.
Our findings suggest that quantification of patients’
quality of life scores at the point of successful ventilatory
weaning may be important in planning their rehabilita-
tion. To our knowledge, quality of life scores are not
routinely measured in many ICUs outside of a research
environment. Compared to other quality of life tools we
have used in ICU research, the EQ5D tool has the
advantage that it is fast and feasible to administer. As
all quality of life tools are proprietary in nature, we
acknowledge the challenges of translation into practice
in financially constrained health-care environments.
However, where feasible, we recommend that quality of
life measures should be incorporated into the routine
care of ICU patients, particularly those who have experi-
enced prolonged mechanical ventilation.
PHYSIOTHERAPY THEORY AND PRACTICE 5
This study is the first to identify which patients may
benefit most from threshold-based IMT in the postwean-
ing period. Patients with at least moderate inspiratory
muscle strength, and moderate to high quality of life
scores at the point of ventilatory weaning, are likely to
achieve significant gains in inspiratory muscle strength
with 2 weeks of daily supervised IMT. Threshold-based
IMT is less likely to produce large gains within 2 weeks in
patients with inspiratory muscle strength less than
28 cmH2O (MIP) or quality of life scores below 40
(EQ5D). Alternative approaches may be better for these
subgroups, and this deserves further exploration.
Conclusions
In patients recently weaned from prolonged mechanical
ventilation, 2 weeks of daily IMT is likely to produce
greatest strength benefits in patients with moderate
inspiratory muscle strength (>28 cmH2O) and moder-
ate to high quality of life (EQ5D > 40). Physiotherapists
should target these patients as ideal candidates for IMT
in the postweaning rehabilitation period.
Acknowledgments
The authors wish to gratefully acknowledge the Canberra
Hospital Private Practice and Auxiliary Research Funds for
making this research possible, as well as the staff of the Acute
Support Physiotherapy Department for their assistance with
the intervention.
Conflict of interest
The authors state that there is no conflict of interest.
Ethics approval
This study was approved by the Australian Capital Territory
Health Human Research Ethics Committee (ETH.10.10.370)
and the University of Queensland Medical Research Ethics
Committee (2010001488).
Funding
We gratefully acknowledge the Canberra Hospital Private
Practice Fund and the Canberra Hospital Auxiliary
Research Fund.
Prior presentation
Australia New Zealand Intensive Care Society Scientific
Meeting, Gold Coast, Australia, October 2017.
6 B. M. BISSETT ET AL.
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