Original Article

Ann Rehabil Med 2020;44(3):246-255

pISSN: 2234-0645 • eISSN: 2234-0653
https://doi.org/10.5535/arm.19100 Annals of Rehabilitation Medicine

Efficacy and Safety of Abdominal Trunk Muscle

Strengthening Using an Innovative Device in
Elderly Patients With Chronic Low Back Pain:
A Pilot Study
Satoshi Kato, MD, Satoru Demura, MD, Yuki Kurokawa, MD, PhD, Naoki Takahashi, MD,
Kazuya Shinmura, MD, Noriaki Yokogawa, MD, Noritaka Yonezawa, MD, Takaki Shimizu, MD,
Ryo Kitagawa, MD, Hiroyuki Tsuchiya, MD

Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan

Objective To examine the efficacy and safety of an innovative, device-driven abdominal trunk muscle strengthening
program, with the ability to measure muscle strength, to treat chronic low back pain (LBP) in elderly participants.
Methods Seven women with non-specific chronic LBP, lasting at least 3 months, were enrolled and treated
with the prescribed exercise regimen. Patients participated in a 12-week device-driven exercise program which
included abdominal trunk muscle strengthening and 4 types of stretches for the trunk and lower extremities.
Primary outcomes were adverse events associated with the exercise program, improvement in abdominal trunk
muscle strength, as measured by the device, and improvement in the numerical rating scale (NRS) scores of LBP
with the exercise. Secondary outcomes were improvement in the Roland-Morris Disability Questionnaire (RDQ)
score and the results of the locomotive syndrome risk test, including the stand-up and two-step tests.
Results There were no reports of increased back pain or new-onset abdominal pain or discomfort during or
after the device-driven exercise program. The mean abdominal trunk muscle strength, NRS, RDQ scores, and the
stand-up and two-step test scores were significantly improved at the end of the trial compared to baseline.
Conclusion No participants experienced adverse events during the 12-week strengthening program, which
involved the use of our device and stretching, indicating the program was safe. Further, the program significantly
improved various measures of LBP and physical function in elderly participants.

Keywords Abdominal muscles, Elderly, Low back pain, Physical therapy, Strengthening

Received July 29, 2019; Revised September 19, 2019; Accepted November 11, 2019; Published online May 29, 2020
Corresponding author: Satoshi Kato
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kanazawa University, 13-1 Takara-machi, Kanazawa 920-8641, Japan. Tel:
+81-76-265-2374, Fax: +81-76-234-4261, E-mail: skato323@gmail.com
ORCID: Satoshi Kato (https://orcid.org/0000-0003-4762-5932); Satoru Demura (https://orcid.org/0000-0002-5703-3802); Yuki Kurokawa (https://
orcid.org/0000-0001-5665-4829); Naoki Takahashi (https://orcid.org/0000-0002-0177-8573); Kazuya Shinmura (https://orcid.org/0000-0002-8583-
4615); Noriaki Yokogawa (https://orcid.org/0000-0002-3415-5823); Noritaka Yonezawa (https://orcid.org/0000-0002-8037-6213); Takaki Shimizu
(https://orcid.org/0000-0001-7681-0593); Ryo Kitagawa (https://orcid.org/0000-0002-3947-3193); Hiroyuki Tsuchiya (https://orcid.org/0000-0003-
0730-7921).
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/
licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright © 2020 by Korean Academy of Rehabilitation Medicine
 Abdominal Trunk Muscle Strengthening in Elderly Patients

INTRODUCTION measures carried out with the device do not induce stress
and/or pain in the lumbar spine or the extremities. A pri-
The economic and social burdens of low back pain or validation study demonstrated that the device could
(LBP) are considerable, and growing [1]. Among elderly measure muscle strength and featured excellent intra-
adults, LBP is the most frequently reported musculoskel- and inter-rater reliability [17,18]. Another study found
etal complaint and the third most frequently reported that strength training with the device increased both the
symptom of any kind [2,3]. Although multiple clinical strength and activation of the abdominal trunk muscles,
interventions are available to treat chronic low back including the diaphragm, abdominal rectus, external and
pain (CLBP), only a few have been proven effective [4–7]. internal obliques, transverse abdominal muscles, and
Exercise is clearly effective for treating CLBP [6–11]. A pelvic floor muscles [18]. However, the authors did not
systematic review by Hayden et al. [11] reported that evaluate the efficacy of exercise that used the device for
strengthening exercises are the most effective options treatment of CLBP treatment. Determining the efficacy
for improving functional outcomes among the various and safety of device use by elderly patients is particularly
types of exercise therapies. Unfortunately, motivation important in terms of clinical utility.
and adherence to exercise therapies are generally low The purpose of this pilot study was to examine the effi-
among elderly patients with CLBP [12]. Exercise requires cacy and safety of exercise using the device for treatment
a much longer time to decrease pain than oral medica- of CLBP in elderly patients.
tions or injections, which are often prescribed to elderly
patients. Elderly patients with CLBP often report they MATERIALS AND METHODS
cannot, or will not, exercise owing to mobility difficulties
associated with loss of strength, flexibility, or endurance, Ethics statement
and presence of pain and/or deformities in the spine and Our university hospital ethics committee approved
extremities [13,14]. These problems reduce exercise ad- this trial (No. 2016-009). Written informed consent was
herence in elderly patients with CLBP, thus diminishing obtained from each prospective participant before reg-
the potential effects. Hence, important considerations for istration by research physicians, in accordance with
CLBP exercise therapy include the ability of the patient the Declaration of Helsinki (Clinical trial registration:
to perform the exercise easily and repeatedly to achieve UMIN000023181).
early and recognizable effects while meeting short-term
goals [12].
Locomotive syndrome is characterized by restricted or
limited ability to walk due to degenerative dysfunction
of locomotive organs [15]. Syndrome progression can
impair activities of daily living and increase nursing care
needs. Exercise interventions for locomotive syndrome
are effective for improving physical function. However,
we should be careful when choosing the type and inten-
sity of exercise because most patients are elderly and also
exhibit degenerative musculoskeletal system dysfunction
[16]. A B
We developed a novel exercise device for the abdominal
trunk muscles (Nippon Sigmax Co. Ltd., Tokyo, Japan) Fig. 1. Innovative exercise device for the abdominal trunk
(Fig. 1). This device allows patients to perform abdominal muscle. (A) Photograph of a device-equipped patient. Us-
ing the device, the patient can measure their abdominal
trunk muscle strengthening exercises while in a sitting
trunk muscle strength or perform strengthening exercise
position, and requires no trunk movement. The device in sitting position without requiring trunk movement. (B)
also enables patients to measure their abdominal trunk Photograph of the device. It consists of an inflatable cuff
muscle strength. Additionally, exercises and strength and a mechanical manometer to measure pressure.

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Satoshi Kato, et al.

Participants significant neurological signs or specific spinal patholo-

This trial was conducted between July 2016 and July gies (e.g., malignancy, infection, acute vertebral fracture),
2017 in the Department of Orthopaedic Surgery and Re- history of spinal surgery, severe osteoporotic spine, severe
habilitation within our university hospital. All participants medical comorbidities (e.g., cardiovascular, respiratory,
were diagnosed with CLBP by a physician and referred to or renal disease), comorbid rheumatologic disease, or co-
our institute. Inclusion criteria were diagnosis of CLBP, morbid dementia (Tables 1, 2).
of at least 3 months duration, by a physician; age ≥65
years; moderate or severe CLBP (LBP intensity ≥3 based Exercise device
on an 11-point numerical rating scale [NRS] pain score, The device resembles a sphygmomanometer, with an
no pain=0, and worst pain=10) at study registration; ca- inflatable cuff and a mechanical manometer for measur-
pable of performing the prescribed exercise regimen in ing pressure [17] (Fig. 1). To take a measurement while
this trial, and capable of understanding the content of the seated, the cuff is placed around the participant’s abdo-
trial and providing informed consent after having the trial men, inflated, and pressure (i.e., the baseline pressure;
explained by a physician. We excluded individuals with Fig. 2) is applied to the abdominal wall. An electrically
operated pump inflates the cuff until adequate resistance
from the abdominal wall is detected. The magnitude of
Table 1. Participant characteristics (n=7) the baseline pressure is set based on the participant’s
Characteristic Value preference. Under this baseline pressure, the participant
Age (yr) 75.4±6.1 (68–84) generates his or her maximum force by contracting the
Height (cm) 151.0±7.4 (139–161) abdominal trunk muscles. The cuff pressure increases
Weight (kg) 56.9±8.9 (45–72) and eventually peaks (i.e., the peak pressure; Fig. 2). At
BMI (kg/cm2) 24.9±3.1 (22.0–31.6) this point, the manometer calculates and reports a pres-
NRS of CLBP at the start of the trial 5.4±1.6 (4–9) sure value. This value is obtained by subtracting the
Values are presented as mean±standard deviation (range). baseline pressure from the peak pressure, thereby pro-
BMI, body mass index; NRS, 11-point numerical rating ducing an estimate of abdominal trunk muscle strength.
scale; CLBP, chronic low back pain. After the pressure peaks, it decreases automatically while

Table 2. Inclusion/exclusion criteria of the study Muscle strength value: 10.0 kPa (peak baseline)
Pressure measured by the monometer (kPa)

Inclusion criteria 20
· D iagnosis of CLBP lasting at least 3 months by a
physician
15 Peak pressure
· 65-year-old or older (15.0 kPa)

· Moderate or severe CLBP: 3 or more by NRS pain Abdominal trunk muscle strength

score at study registration 10

· Capable of performing the prescribed exercise regi-

men in this trial 5 Baseline pressure
· Capable of understanding the content of the trial, (5.0 kPa)

and giving the informed consent

Exclusion criteria
5 A B 10
· Significant neurological sign or specific spinal pa- Time (sec)
thology
· History of spinal surgery Fig. 2. Time course of the pressure value calculated by
the mechanical manometer of the device during the
· Severe osteoporotic spine
measurement of abdominal trunk muscle strength. “A”
· Comorbidity of severe medical diseases, rheumato- indicates the time point when the patient’s abdominal
logical disease, or dementia muscles begin to contract against the pressure. “B” shows
CLBP, chronic low back pain; NRS, 11-point numerical the reduction in pressure in the cuff after the peak pres-
rating scale. sure is attained.

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 Abdominal Trunk Muscle Strengthening in Elderly Patients

the air in the cuff is released. The muscle strength value participant contracts his or her abdominal trunk muscles
was considered as an estimate of the abdominal trunk intermittently, or continually, in opposition to cuff pres-
muscle strength. sure. This exercise resembles a bracing exercise and is
While using the device for muscle strengthening, the stabilizing [19]. When the cuff pressure peaks, the par-
ticipant performs isometric and maximum muscle con-
tractions under maximum pressure from the cuff. During
Pressure measured by the monometer (kPa)

20 the strengthening exercise and during muscle strength

measurement, isometric or eccentric abdominal trunk
15 muscle contraction occurs under the cuff pressure. These
device-driven exercises allow participants to contract
their abdominal trunk muscles easily and with increased
10
power.

5 5.0 kPa Run-in period (preparation)

A run-in period of 2 weeks was designed to ensure the
stability of the participants with CLBP before starting the
5 10 15 20 intervention. During the 2-week run-in period and the
Time (sec) 12-week trial period, all participants were asked to dis-
Fig. 3. Time course of the pressure value calculated by the continue any pain medications—except loxoprofen so-
mechanical manometer of the device during abdominal dium, other exercises, and local injections—if they were
trunk muscle strengthening. The participants exerted the receiving these treatments. As a result, none of the 7 par-
force necessary for the pressure in the cuff to reach 50% ticipants took any pain relievers during the run-in or trial
to 80% of the peak pressure measured at the beginning of
period. However, loxoprofen sodium was allowed during
the exercise. Intermittent muscle contractions were per-
formed once every 10 seconds, with 5 seconds of muscle the run-in and study periods.
contraction and 5 seconds of rest in the 10-minute ses-
sion.

Fig. 4. Four types of stretching ex-

A B ercises conducted in the trial. (A)
Lumbar flexion, and knee and hip
flexions in the supine position,
stretching the back and gluteal
muscles. (B) Lumbar rotation in
the supine position, stretching the
abdominal muscles. (C) Straight
leg raising in the supine position,
stretching the hamstrings. (D)
Lumbar extension and knee flex-
ion in the prone position, stretch-
ing the abdominal, iliopsoas, and
C D
knee extensor muscles.

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Interventions Table 3. Scoring system of stand-up test

After the run-in period, all participants were transi- Height (cm) Score
tioned to a 12-week, device-driven exercise program Two-leg stand
which consisted of strengthening and stretching ex- Fail at 40 0
ercises. The strengthening exercises consisted of ab- 40 1
dominal trunk muscle strengthening for 10 minutes per 30 2
session. Strength measurements using the device were 20 3
routinely performed before exercise sessions. During the 10 4
strengthening exercise, each participant was instructed One-leg stand
to intermittently contract the abdominal trunk muscles 40 5
under the cuff pressure and exert the force necessary for 30 6
the cuff pressure to reach 50%–80% of the peak pressure, 20 7
as measured at the beginning of the exercise (Fig. 3). 10 8
Intermittent muscle contractions were performed once
One-leg stand requires participants to succeed at indi-
every 10 seconds, with 5 seconds of muscle contraction cated height in both right and left leg.
and 5 seconds of rest. The stretching exercise consisted
of 4 types of abdominal and back muscle, iliopsoas, glu-
teal muscle, and hamstring stretches (Fig. 4) along with Questionnaire (RDQ). Locomotive syndrome was as-
lumbar spine mobilization. Each strengthening exercise sessed using the locomotive syndrome risk test compris-
and stretch were performed twice in our hospital’s reha- ing the stand-up test, two-step test, and the 25-Question
bilitation room. Vital signs, including blood pressure and Geriatric Locomotive Function Scale (GLFS-25) [16].
heart rate, were measured prior to, and at the end of, two These secondary outcomes were evaluated at 0 and 12
strengthening sessions. The whole program, including weeks (start and end of the intervention). To evaluate the
exercises and vital sign measurement, took approximate- result of the stand-up test, participants were assigned a
ly 30–40 minutes. Participants were asked to visit our score that ranged from 0–8, as shown in Table 3 [20].
hospital three times per week for 12 weeks. Therefore, the
program consisted of a total of 36 exercise sessions. Comparisons between good and limited responders
Based on the improvement in abdominal trunk muscle
Outcomes strength, as measured with the device during the trial,
Primary outcome participants were identified as good (those whose muscle
The primary outcomes were adverse events associated strength increased by ≥3.0 kPa after the exercise pro-
with the exercise program, improvements in abdominal gram) or limited (those whose strength increased by <3.0
trunk muscle strength as measured by the device, and kPa after the exercise program) responders. Outcomes
LBP intensity (NRS pain score) during the exercise. Ad- were compared between the two groups.
verse events and muscle strength were evaluated at every
visit to our office while the participant performed the Statistical analysis
exercises. Abnormal vital sign changes were defined as Data are presented as means and standard deviations.
a >30% increase in systolic blood pressure and/or heart To evaluate the effects of the intervention, we used the
rate after the strengthening exercise. Patients were asked Friedman test to evaluate differences in the primary out-
to rate their LBP using the NRS score over the last 3–5 come variables of the abdominal trunk muscle strength
days. NRS of LBP was evaluated at 0 (start of the interven- trials, as measured by the device and NRS of LBP at 0, 4, 8,
tion), 4, 8, and 12 (end of the intervention) weeks. and 12 weeks. The Wilcoxon signed-ranked test was used
to evaluate differences in the secondary outcomes at the
Secondary outcome beginning (0 week) and end (12 weeks) of the interven-
Disability and quality of life (QOL) impairment due to tion. The Mann-Whitney U-test was used to evaluate
LBP were evaluated using the Roland-Morris Disability improvements in outcomes between good and limited

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 Abdominal Trunk Muscle Strengthening in Elderly Patients

responders. All significance levels were set at 0.05. SPSS The mean abdominal trunk muscle strength was sig-
version 19.0 for Windows (IBM Corp., Armonk, NY, USA) nificantly increased at 8 and 12 weeks (end of the trial)
was used for statistical analyses. compared to 0 week (baseline) and 4 weeks (Table 4).
The mean NRS scores of LBP were significantly decreased
RESULTS at 4, 8, and 12 weeks compared to 0 week. The mean
NRS score gradually decreased over time, and was lower
Seven participants were enrolled and treated with the at 8 weeks than at 4 weeks (Table 4). Based on muscle
prescribed exercise regimen in this trial. All participants strength improvement, 4 participants were identified as
were females, with a mean age of 75.4 years (range, 68–84 good responders, and 3 as limited responders (Table 4).
years). Participants’ characteristics and inclusion/exclu-
sion criteria are summarized in Tables 1 and 2. Secondary outcomes
The mean RDQ score was significantly lower at the end
Primary outcomes of the trial than at the start (3.9±3.4 vs. 6.0±4.1, p<0.05)
None of the 7 participants experienced adverse events (Table 5). With regard to the locomotive syndrome risk
during the trial period. There were no reports of in- test, the mean scores of the stand-up and two-step tests
creased back pain or new-onset abdominal pain or dis- were significantly improved at the end of the trial com-
comfort during or after the device-driven exercise pro- pared to baseline (Table 5). However, the mean scores of
gram. No abnormal changes in blood pressure or heart the GLFS-25 at the end of the trial were not significantly
rate were observed during the exercise program. increased over baseline.

Table 4. Primary outcomes during the time courses in the trial

0 week 4 weeks 8 weeks 12 weeks
ATMS (kPa)
All participants (n=7) 4.4±2.1 (1.6–6.4) 4.6±2.1 (1.1–6.8) 6.7±2.9 (2.5–9.9)a,b) 7.8±3.7 (2.5–13.3)a,b)
Good responders (n=4) 4.4±2.2 (1.6–6.3) 5.5±1.8 (2.8–6.8) 7.8±3.0 (3.4–9.9) 9.5±3.5 (5.9–13.3)
Limited responders (n=3) 4.4±2.4 (1.7–6.4) 3.5±2.1 (1.1–5.0) 5.3±2.4 (2.5–6.8) 5.7±2.9 (2.5–8.3)
NRS of LBP
All participants (n=7) 5.4±1.7 (4–9) 4.1±1.2 (3–6)a) 3.3±1.3 (1–5)a,b) 3.1±1.3 (1–5)a)
Good responders (n=4) 6.2±1.9 (5–9) 4.8±1.3 (3–6) 3.3±1.7 (1–5) 3.3±1.0 (2–4)
Limited responders (n=3) 4.3±0.6 (4–5) 3.3±0.6 (3–4) 3.3±0.6 (3–4) 3.0±2.0 (1–5)
Values are presented as mean±standard deviation (range).
ATMS, abdominal trunk muscle strength; NRS, 11-point numerical rating scale; LBP, low back pain.
a)
p<0.05 (vs. the outcome at 0 week), b)p<0.05 (vs. the outcome at 4 week).

Table 5. Outcomes of the muscle strength, and the conditions of LBP and the locomotive syndrome
Outcomes Before the exercise at 0 week After the exercise at 12 weeks p-value
AMTS (kPa) 4.4±2.1 7.8±3.7 <0.05
NRS of LBP 5.4±1.7 3.1±1.3 <0.05
RDQ score 6.0±4.1 3.9±3.4 <0.05
Stand-up test score 3.7±1.0 4.7±0.8 <0.05
Two-step test score 1.23±0.09 1.46±0.07 <0.05
Score of the GLFS-25 15.0±11.0 12.4±10.0 0.13
Values are presented as mean±standard deviation.
LBP, low back pain; ATMS, abdominal trunk muscle strength; NRS, 11-point numerical rating scale; RDQ, the Roland-
Morris Disability Questionnaire; GLFD-25, 25-Question Geriatric Locomotive Function Scale.

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Satoshi Kato, et al.

Table 6. Comparison of improvement of outcomes between the good and limited responders
Outcomes Good responders (n=4) Limited responders (n=3) p-value
ATMS (kPa) 5.1±1.8 1.1±0.7 <0.05
NRS of LBP 3.0±1.4 1.3±1.5 0.20
RDQ score 3.0±4.1 1.0±1.0 0.45
Stand-up test score 1.5±0.6 0.3±0.6 <0.05
Two-step test score 0.24±0.05 0.23±0.02 0.96
Score of the GLFS-25 4.3±5.9 0.3±2.1 0.33
Values are presented as mean±standard deviation.
ATMS, abdominal trunk muscle strength; NRS, 11-point numerical rating scale; LBP, low back pain; RDQ, the Roland-
Morris Disability Questionnaire; GLFD-25, 25-Question Geriatric Locomotive Function Scale.

Comparisons between good and limited responders core muscles such as the transverse abdominis. The brac-
The mean improvement in the stand-up test score was ing exercise further provided protection against sudden
significantly better in good responders than in limited trunk perturbations [25,26]. During daily activities, ideal
responders. The mean improvements in the NRS score of spinal stabilization coordinates all deep and superficial
LBP, RDQ score, and the GLFS-25 score were also better core muscles [27]. The abdominal contraction used with
in good responders than in limited responders, but these the device is similar to that used during abdominal brac-
differences were not significant (Table 6). ing, creating a coordinated contraction of the deep and
superficial core muscles at the anterolateral aspect, roof,
DISCUSSION and floor of the “muscular box” [18]. Lumbar stabiliza-
tion exercises include “bridging” exercises such as the
This trial combined a device-driven abdominal trunk plank, side-bridge, and pelvic tilt. Okubo et al. [28] dem-
muscle strengthening program and stretching exercises. onstrated that the superficial and deep muscles in the
We wanted to offer participants a practical exercise pro- trunk were coactivated, but the activation level of each
gram and evaluate the program as a comprehensive exer- muscle differed according to the exercise. Many elderly
cise treatment protocol. Our results indicated that the 12- patients with CLBP cannot perform bridging exercises
week exercise program—which consisted of stretching due to deteriorated physical function, including pain
and strengthening exercises combined with use of our and/or weakness in the trunk and extremities [13,14].
innovative device—was safe and not associated with any The device-driven abdominal trunk muscle strengthen-
adverse events. The program effectively improved LBP, ing exercises are performed while seated, did not stress
physical function, and abdominal trunk muscle strength lumbar spine movement. The exercise used in this trial
in elderly patients. did not induce pain in the trunk or extremities of elderly
Lumbar stabilization exercises are designed to improve patients with CLBP. Because of this, participants contin-
stability in the lumbar spine and protect the spinal joints ued to perform the exercises, eventually completing the
from microtraumas and degenerative changes. These ex- entire program.
ercises have been applied to treatment of CLBP [6,21–23]. Several studies reported that trunk muscle strength
The core muscles resemble a muscular box, with the dia- was significantly lower in patients with LBP compared to
phragm as the roof, abdominal muscles forming the front asymptomatic participants [29–31]. A systematic review
and sides, paraspinal muscles in the back, and pelvic demonstrated that weak trunk muscle strength was as-
floor muscles on the bottom [22]. Diaphragm contraction sociated with poor physical function, including impaired
stabilizes the spine by increasing intra-abdominal pres- balance and increased incidence of falls in the elderly
sure [22]. Brown et al. [24] proposed a bracing exercise [32]. Granacher et al. [33] reported that, in elderly indi-
for lumbar stabilization and reported that the bracing viduals with core instability, strength training improved
technique produced better spinal stabilization results trunk muscle strength, dynamic balance, and functional
than the hollowing exercise, which activates the deep mobility. The device-driven exercise program in this

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 Abdominal Trunk Muscle Strengthening in Elderly Patients

trial—which included device-driven abdominal trunk cerebrovascular, or gynecological diseases; or other med-
muscle strengthening exercises—improved dynamic bal- ical conditions.
ance and functional mobility. These factors were using The present study has several limitations, including
the locomotive syndrome risk test in elderly adults with the small sample size and lack of a control group. Im-
CLBP. provements in CLBP and physical functions identified in
The device-driven exercise program improved muscle the trial included the effect of stretching. A prospective,
strength, as measured using the device in all participants. comparative controlled study a larger cohort is required
Although most of the differences were not significant due to affirm these findings. Further studies are needed to
to the small number of participants, good responders compare outcomes among the device-driven exercises,
showed increased pain reduction and physical function other lumbar stabilization exercises, or other exercises
compared to limited responders. In good responders, prescribed for CLBP treatment. The study participants
improvement of the stand-up test score was significantly did not experience any device-related adverse effects or
better than that in limited responders. The stand-up limitations. Future studies with a larger cohort, a wider
movement requires adequate abdominal trunk muscle age range, and both sexes are required to recognize draw-
contraction and strength, as well as lower extremity mus- backs that might influence device utility.
cle strength, adequate joint range of motion, flexibility, Despite these limitations, our results demonstrated the
and balance [16]. Abdominal trunk muscle strengthen- efficacy of device-driven strengthening exercises, in com-
ing directly improved these important physical functions bination with stretching, for improving CLBP, physical
during activities of daily living. A lack of consensus on function, and abdominal trunk muscle strength in elderly
how to measure core muscle strength has weakened the patients with CLBP. The device-driven strengthening ex-
impact of this research on determining optimal core sta- ercise was safe and could be a good treatment option to
bility exercises [27]. If we can easily and quickly measure reduce CLBP and improve physical function, especially
core instability and muscle weakness, we can determine among elderly patients.
the outcomes and place proper emphasis on core muscle
strengthening in patients. Our device could be a practi- CONFLICT OF INTEREST
cal option for measuring core muscle strength. Further, it
may also improve adherence to strengthening exercises. Nippon Sigmax Co. Ltd. provided the exercise device
A systematic review reported that stretching produced used in this clinical trial. The authors declare that they
the largest improvements in pain outcome measures. In have no conflict of interest.
contrast, strengthening exercises were most effective for
improving functional outcomes among the various types AUTHOR CONTRIBUTION
of exercise therapies [11]. Device-driven strengthening
exercises, combined with stretching, could help elderly Conceptualization: Kato S. Data collection: Kato S,
participants improve their physical function and reduce Kurokawa Y, Takahashi N, Yokogawa N, Yonezawa N,
LBP. Shimizu T, Kitagawa R. Interpretation of data: Kato S, De-
Previous studies reported that muscle strength mea- mura S, Shinmura K. Formal analysis: Kato S, Kurokawa
surement and device-driven strengthening exercises did Y. Writing - original draft: Kato S. Writing - review and
not exert adverse effects in young adults [17,18]. Similar- editing: Demura S, Tsuchiya H. Supervision: Tsuchiya H.
ly, in the present study, use of the device for 12 weeks did Approval of the final manuscript: all authors.
not produce adverse effects in elderly patients with CLBP.
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