706
K. Nakamura et al.
The aim of the current study was to evaluate the
efficacy of B-SES in reducing muscle volume loss in
the early acute phase in ICU patients. A randomized
control trial (RCT) was conducted. Functions such as
ADL are most important for patients; however, main-
tenance of skeletal muscle volume is also important
for critically ill patients. Loss of muscle volume is
associated with muscle weakness, impaired physical
function and mortality (19, 20). An earlier study by our
group assessed femoral muscle volume using compu-
ted tomography (CT) scanning to evaluate ICU-AW
with high inter-rater reliability and 3-dimensional eva-
luation (21). In the current study was used to evaluate
exact and whole femoral muscle volume loss before
and after intensive care with and without B-SES.
MATERIAL AND METHODS
Patient selection
Patients admitted to the ICU at the emergency and critical care
centre of Hitachi General Hospital from September 2017 to March
2018 were included in the study. This is a medical and surgical
ICU for patients admitted from the emergency department and
those with in-hospital acute deterioration. Exclusion criteria
were: patients who had had a scheduled operation; mild cases or
expected discharge from the ICU within 3 days; died by day 2;
second admission to our ICU; younger than 20 years old; pregnant
or believed pregnant; extracorporeal membrane oxygenation;
multiple-drug-resistant bacteria detected; lower extremity event,
such as infection, injury, or amputation; pacemaker implanted;
neuromuscular diseases; CT not performed on the first day; desig-
nated as “do not attempt resuscitation”; unable to obtain informed
consent; or cases included in other clinical trials.
This study is registered in University hospital Medical
Information Network, UMIN000029349 on 29 Sep 2017.
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.
cgi?recptno=R000033541.
This study was approved by the Ethics Review Board of
Hitachi General Hospital (2017-52) and registered in Univer-
sity hospital Medical Information Network (UMIN) (number
000029349). Informed consent was obtained from all the
participants.
both sides. Electrical muscle stimulation and exercise were
introduced throughout the abdomen and all lower extremities
between the belts (Fig. 1). Thereafter, EMS (frequency 20 Hz,
pulse width 250 μs) was administered once a day, for 20 min,
with a duty cycle with stimulation for 5 s and a 2-s pause. The
electrical intensity was adjusted by the physical therapist based
on adequate muscle contraction according to patient response,
expression or change in vital signs, including heart rate.
In both groups, the other physical therapies, including range
of motion exercise, mobilization and ambulation, were provi-
ded by nurses (at times other than the 20-min EMS) according
to the patient’s condition, both in the ICU and in the general
ward. Rehabilitation intensity was planned and adjusted by the
physical therapists once daily, and the nurses provided rehabili-
tation following their instructions. The rehabilitation, including
muscle loading or EMS, was administered daily, including
during holidays. The EMS or control rehabilitation provided by
physical therapists in the ICU was continued until day 10 using
the same procedure, even if the patient was discharged from
the ICU to the general ward, while the frequency and intensity
of rehabilitation provided by nurses in the general ward was
reduced under the direction of the physical therapists, taking
into account the patient’s condition. Rehabilitation protocols
for both groups are described in Table I. Sedation and analge-
sia were planned and adjusted by the medical doctors, and not
changed due to the rehabilitation. Weaning and spontaneous
breathing trials for mechanical ventilation were also performed
by the medical doctors.
This clinical study was approved by the ethics board of our
hospital (2017-52) and is registered at the University Hospital
Medical Information Network (UMIN) (number 000029349).
Outcomes and measurements
Acute skeletal muscle wasting in femoral muscles has been
reported to occur within 10 days in critical illness (22), therefore
the primary outcome chosen for this study was change in femoral
muscle volume (%) from the first day the patient was admitted
to ICU (day 1) to day 10. In both groups, plain femoral CT was
performed on day 1 and day 10. Day 10 CT was performed even
if the patient was discharged from the ICU to the general ward.
Cases discharged from the hospital by day 10 were excluded.
Protocol
Informed consent was received from patients who had been
admitted to the ICU. Included subjects were assigned a random
number 0 or 1 using software (FileMaker pro 16; FileMaker,
Inc., Santa Clara, CA, USA), designating them as members of
the control group or EMS group, respectively. Treatments were
started with non-blinded patients. In both groups early rehabili-
tation was introduced by the physical therapists from the second
day of ICU admission (day 2). In the control group, physical
therapists gave the patients the maximum possible muscle
loading, including range of motion exercise, kicking stability
ball, standing exercise and ambulation exercise, depending on
the patient’s condition, for 20 min a day, on the bed or at the
bedside. In the EMS group, belt-type EMS (G-TES®; Homer
Ion Corp., Osaka, Japan) was applied by physical therapists
from day 2. Belt electrodes were attached at 5 points: around
the patient’s waist, above the knees and above the ankles on
www.medicaljournals.se/jrm
Fig. 1. Belt-electrode skeletal muscle electrical stimulation (B-SES). The
belt electrodes were attached to 5 points: around the patient’s waist,
above the knees, and above the ankles. Electrical muscle stimulation and
exercise were introduced between the belts throughout the abdomen
and both lower extremities.