Glycative Stress Research
Online edition : ISSN 2188-3610
Print edition : ISSN 2188-3602
Received : July 10, 2018
Accepted : August 13, 2018
Published online : September 30, 2018
doi:10.24659/gsr.5.3_135

Original article

Effect of special insole fitting on walking exercise: An open-label study.
Yuji Morita 1, 2), Wakako Takabe 1), Masayuki Yagi 1), Fuka Okuda 1), Misato Kon 1), Kenichi Asada 2),
Tetsuro Urata 2), Hiroshi Yatou 3), Hiroomi Maeda 3), Yoshikazu Yonei 1)
1) Anti-Aging Medical Research Center and Glycative Stress Research Center, Faculty of Life and Medical Sciences,
Doshisha University, Kyoto, Japan
2) Urata Clinic/SQOL Kanazawa, Kanazawa, Ishikawa, Japan3) ASICS Trading Co. Ltd., Kobe, Japan

Abstract

Objective: The aim of this study was to evaluate the effects of walking movements exerted while wearing insoles produced
experimentally which simulate the characteristics of walking on a sandy beach. The examinations were conducted, comparing
between groups who walked with and without insoles.
Methods: Research participants were 12 healthy females with a shoe size between 22.5 and 23.5 cm (age: 29.9 ± 3.3 years,
BMI: 19.2 ± 2.6). A treadmill walking examination was conducted for the groups without specially processed insoles, andthen after a washout period (1 week), an examination using the test insoles was conducted. Blood tests were performed before
and after walking.
Results: Data results showed an increase in serum levels of growth hormones. However, differences in the hormones between
the absence or presence of the insoles were not observed. There were no significant changes in cortisol, Triglyceride (TG),
Plasma glucose (PG) and Immunoreactive insulin (IRI). Insole equipment enabled the prevention of a shoe blister.
Conclusion: Considering the effects of the test insoles in an electromyography from a prior examination recognized anincrease in muscle force generation, this study suggested a possibility that this test product had scarce adverse events, and load
training effects of the insoles on the lower thigh muscles were expected.

KEY WORDS: insole, walking, growth hormone, electromyography (EMG), coast walking

Introduction

Lifestyle-related diseases with considerable glycative
stress have been increasing recently in many countries,
including Japan, such as visceral fat obesity, diabetes mellitus,
metabolic syndrome and hyperlipidemia. Therapeutic exercises
play an essential role as countermeasures against glycative
stress. Among the exercises, walking is the most familiar
physical activity. Ambulation extends beneficial effects
not only to control glycative stress on the prediction andprevention of onset and the progression of diabetes mellitus
but also to influence motor and neurological functions 1-6).
We hypothesized that focusing on footwear would recreate

the remarkable effect of walking with the characteristics orimages of a sandy beach; footwear must feel comfortable towear and at the same time provide large loads on muscles.
Based on this concept, we have developed a prototype of
specially processed insoles fitting foot-shape and enableda sole of foot to sink deeper while stepping or treading. A
comparative examination was conducted to evaluate thephysical effects of a 30-minute walking exercise with andwithout the specially produced insoles, focusing on thesecretion of growth hormone (GH) as an indicator.

Contact Address: Professor Yoshikazu Yonei, MD, PhD
Anti-Aging Medical Research Center, Graduate School of Life and Medical Sciences, Doshisha University
1-3, Tatara Miyakodani, Kyotanabe, Kyoto, 610 - 0394 Japan
Phone/Fax: + 81-774 -65-6394 Email: yyonei@mail.doshisha.ac. jp
Co-authors; Morita Y, ymorita707@yahoo.co. jp ; Takabe W, wtakabe@mail.doshisha.ac. jp ;Yagi M, yagi@yonei-labo.com ; Okuda F, ctuc2017@mail4.doshisha.ac. jp ;Kon M, ctuc2013@mail4.doshisha.ac. jp ; Asada K, asada@hospy.jp ; Urata T, tetsuro.u@hospy. jp ;Yatou H, h-yatou@asics-trading.co. jp ; Maeda H, h-maeda@asics-trading.co. jp_ 135 _

Glycative Stress Research 2018; 5 (3): 135 -146
(c) Society for Glycative Stress Research

Special Insole Fitting and Walking Exercise

Methods

Evaluation points

An open-label study was conducted to evaluate thephysical effects of the specially produced insoles in walking
with 12 healthy female research participants who belonged toor were related to the Urata Clinic or S-QOL Kanazawa andwho were between the ages of 25 and 40 years with a shoe
size between 22.5 and 23.5 cm.
After this study was approved by the Doshisha University
Ethics Review Committee on Research involving Human
Subjects, an information session for the research was
conducted at Urata Clinic and S-QOL Kanazawa (Kanazawa
City, Ishikawa Prefecture, Japan). Research participants were
12 individuals who agreed to participate in this study with awritten consent and who did not meet the following exclusion
criteria.
[1] Individuals with a chronic disease currently receiving
drug treatment[2] Individuals with a serious past medical history and/or
present illness[3] Individuals with serious anemia[4] Individuals who are or may be pregnant[5] Individuals with a disease currently receiving drug
treatment
One subject who had participated in this trial was eliminatedfrom analysis in the clinical conference after the completionof the research. The analysis target was 11 subjects (age: 29.9
± 3.29 years).

Anthropometric measurements involved measurementsof height, weight, body fat, body mass index (BMI), systolicand diastolic blood pressure, and pulse. Organization
composition was examined using a body composition
analyzer (InBody770; InBody Japan, Koto-ku, Tokyo, Japan).

Clinical study design

Ethical consideration

Research participantsThis study was an open-label controlled trial. The
test item was a pair of female pumps to which the newly
developed insoles were attached. The insoles were developed
as an academic-industrial collaboration by the Anti-Aging
Medical Research Center, Doshisha University (Kyoto,
Japan) and ASICS Trading Co., Ltd. (Kobe, Japan) and werecharacterized by recreating the sensation of sandy beachwalking of sandy-beach walking with comfortability inwalking and load training on muscles to enhance muscle
activity. The control item was a pair of female pumps not
equipped with insoles.
Wearing the control item, research participants performed
30 minutes of treadmill walking with an exercise intensity
around 3 METs (Metabolic Equivalents) using a treadmillthat had been set at the walking speed of 4.5 km (Life Fitness
Discover Treadmill SE3, Brunswick Corporation, Illinois,
USA). Glucose load had been provided by 4 0 g of glucose
75 minutes before the start of walking to temporarily inhibit
GH secretion, which was the major assessment item. The firstsample blood collection was performed 15 minutes before
the walking exercise. Hematologic test and biochemical
examination of blood were performed, examining growth
hormone (GH), cortisol, triglyceride (TG), plasma glucose(PG) and immunoreactive insulin (IRI). The second
collection of sample blood was performed after walking toobserve and evaluate changes in GH, cortisol, TG, PG and
IRI, comparing tests before and after walking. After a 1-weekwashout period, wearing the test item, another walking
exercise examination with blood tests was conducted in thesame manner for the controlled item case.
The research period was from March of 2018 to April of
2018.

Anthropometric measurements

Blood test

A peripheral blood test and a biochemical test were
performed using blood samples. Evaluation points inthis study were GH, cortisol, TG, PG and IRI. Clinicalexaminations using blood samples were performed by ALP
Academic Laboratory Pharmacy (Kanazawa City, Ishikawa
Prefecture, Japan).

Statistical analysis

Statistical analysis was conducted using SPSS (IBMJapan, Chuo-ku, Tokyo, Japan) statistical analysis software.
Paired-t test was employed in this analysis, and a hazard rate
less than 5 % was considered to be statistically significant.
Outlier were not excluded from the analysis. However, incases where data were unable to be obtained due to troubles
in the test process or problems of unreliable data occurred,
they were regarded as a missing value and a substitution
value was not employed.

This study was implemented in compliance with theHelsinki Declaration (amended by the 6 4th WMA General
Assembly, Fortaleza, Brazil, 2013) and the Ethical Guidelines
for Medical and Health Research Involving Human Subjects
established by Japan’s Ministry of Health, Labour andWelfare, and Ministry of Education. Further, the Doshisha
University Ethics Review Committee on Research involving
Human Subjects was held to deliberate ethics and validity
for this study, which was approved (application number#17079). Clinical trial registration to UMIN was obtained inadvance (UMIN #000031282).

Results

General backgroundThe general background of 11 subjects for analysis areshown in Table 1 as follows: age 29.9 ± 3.3 years, height156.9 ± 4.3 cm, weight 46.9 ± 5.5 kg and BMI 19.2 ± 2.6.

Growth hormone (GH)In the group with the test article, GH levels before andafter walking were 0.48 ± 0.31 ng/mL and 3.63 ± 3.83 ng/mL,
respectively and GH level was significantly increased (p =0.018, Fig. 1). In the group with the control article, GHlevels before and after walking were 1.12 ± 1.34 ng/mL
and 5.61 ± 5.91 ng/mL, respectively and the GH level was
significantly increased ( p = 0.030). No significant difference
was recognized between the test article group and the control
article group (Table 2).

_ 13 6 _Glycative Stress Research

Table 1. Anthropometry.

Average
Age

Heightcm

Body fat%29.9 ± 3.29
156.9 ± 4.28

kg

WeightBMI

Blood pressure (systolic)
Pulse

/min

(diastolic)46.9 ± 5.47
24.2 ± 3.43

-

mmHg

SD

19.2 ± 2.57
110.4 ± 6.54

mmHg67.8 ± 9.15
83.4 ± 11.19

n = 11. BMI, body mass index; SD, standard deviation.

8＊p=0.018

Serum GH (ng/mL)

7
6
5
4
3
2
1
0

Before walking

After walking

Fig. 1. GH (Test article)

Data are expressed as mean ± SD, paired t test, n = 11. GH, growth hormone; SD, standard deviation.

Table 2. Serum GH

Before walking

After walking

p value

Test article

ng/mL

0.48 ± 0.31

3.63 ± 3.83

0.018

Control article

ng/mL

1.12 ± 1.34

5.61 ± 5.91

0.030

Data are expressed as mean ± SD, paired t test, n = 11. GH, growth hormone; SD, standard deviation.

_ 137 _

Inter- group analysis

0.299

Special Insole Fitting and Walking Exercise

CortisolIn the group with the test article, cortisol levels before andafter walking were 11.1 ± 4.0 μg/dL and 9.5 ± 4.0 μg/dL,
respectively. In the group with the control article, cortisol
levels before and after walking were 10.6 ± 4.4 μg/dL and
7.9 ± 3.3 μg/dL, respectively. No significant difference wasrecognized in both comparisons, between before and after
walking and between groups with the test article and withthe control article (Table 3 ).

Triglyceride (TG)In the group with the test article, TG levels before andafter walking were 62.4 ± 26.0 mg/dL and 52.8 ± 22.3 mg/
dL, respectively. In the group with the control article, cortisol
levels before and after walking were 65.4 ± 32.9 mg/dL and

50.5 ± 16.7 mg/dL, respectively. No significant difference
was recognized in both comparisons, between before andafter walking and between groups with the test article andwith the control article (Table 4).

Plasma glucose (PG)

In the group with the test article, PG levels before
and after walking were 136.8 ± 41.1 mg/dL and 103.6 ±23.1 mg/dL respectively, and PG level was significantly
decreased (p = 0.038). In the group with the control article,
PG levels before and after walking were 140.6 ± 35.7 mg/dL
and 94.7 ± 29. 0 mg/dL, respectively and PG level was
significantly decreased (p = 0.005). No significant difference
was recognized between groups with the test article and thecontrol article (Table 5).

Table 3. Serum cortisol

p value
Before walking

After walking

Before vsafter

Test article

μg/dL

11.13 ± 3.96

9.50 ± 4.04

0.374

Control article

μg/dL

10.59 ± 4.37

7.93 ± 3.31

0.140Inter-group difference
in % change
0. 426

Data are expressed as mean ± SD, paired t test, n = 11. SD, standard deviation.

Table 4. Serum TG

p value
Before walking

After walking

Before vsafter

Test article

mg/dL

62.36 ± 26.01

52.82 ± 22.34

0.389

Control article

mg/dL

65.36 ± 32.89

50.45 ± 16.72

0.216

Inter-group difference
in % change
0.657

Data are expressed as mean ± SD, paired t test, n = 11. TG, triglyceride; SD, standard deviation.

Table 5. PG

p value
Before walking

After walking

Before vsafter

Test article

mg/dL

136.82 ± 41.13

103.64 ± 23.14

0.038

Control article

mg/dL

140.64 ± 35.66

94.73 ± 28.97

0.005

Data are expressed as mean ± SD, paired t test, n = 11. PG, plasma glucose; SD, standard deviation.

_ 13 8 _Inter-group difference
in % change
0.449

Glycative Stress Research

Table 6. Serum IRI

p value
Before walking

After walking

Before vsafter

Test article

μU/mL

24.88 ± 8.25

12.78 ± 8.57

0.004

Control article

μU/mL

29.97 ± 10.95

12.56 ± 9.48

0.001

Inter-group difference
in % change
0.836

Data are expressed as mean ± SD, paired t test, n = 11. IRI, immunoreactive insulin; SD, standard deviation.

Immunoreactive insulin (IRI)

In the group with the test article, IRI levels before andafter walking were 24.9 ± 8.3 μU/mL and 12.8 ± 8.6 μU/mL,
respectively and IRI level was significantly decreased (p =0.004). In the group with the control article, IRI levels before
and after walking were 30.0 ± 11.0 μU/mL and 12.6 ± 9.5
μU/mL, respectively and IRI level was significantly decreased(p = 0.001). No significant difference was recognized between
groups with the test article and the control article (Table 6 ).

SafetyNeither adverse events nor effects occurred in thegroup with the test article, while shoe sores or blisters wererecognized as an adverse event (7 out of 12 subjects, incident
rate 58.3 %) in the group with the control article.

Discussion

Overviews of results

This study examined the effects of walking exercise
wearing a pair of shoes equipped with specially produced
insoles as the test product in an open label trial with 12
healthy female research participants with a shoe size 22.5 23.5 cm (age: 29.9 ± 3.3 years, BMI 19.2 ± 2.6). The clinicalconference after the completion of the tests eliminated one
subject from the analysis. Data of 11 subjects were analyzed
and the following results were obtained:
GH levels were significantly decreased from the tests
before walking compared to after walking in both groups
with the test and the control product. Furthermore, levels of
PG and IRI were significantly decreased between the before
and after walking tests. There was no significant differencein pre- and post-walking change rates between the twogroups. In the test product group, neither adverse events nor
effects occurred, while shoe sores or blisters were recognized
as an adverse event ( 7 out of 12 subjects, incident rate 58.3 %)in the group with the control product.
An examination of the effects of the test product was
conducted with 6 female subjects (age: 40.2 ± 7.6 years, BMI
19.2 ± 1.8), who were not precipitants of this test. Employing
a multipurpose telemetry electromyography DL- 5000
(S&ME, Nakano-ku, Tokyo, Japan), eight sites were examined:
erector spinae, gluteus medius, vastus medialis, vastus
lateralis, soleus, tibialis anterior, tibialis posterior andperoneus brevis. Among these sites, erector spinae muscle
measurement value of the test article was significantly
higher in average rectified values and integrated value ofelectromyogram (EMG) than in those of the control article( Table 7 ). That is, the usage of the insoles enabled theenhancement of the physical activities of erector spinae
muscle.
Judging from the above findings, it has been suggested
that the test products, the specially produced insoles, werecomfortable to wear, were unlikely induce adverse events,
and were assumed to have motional effects due to load
training on erector spinae muscles.

Effects of walking exercise

In this rapidly aging society, people developing
problematic symptoms with their legs and feet have been
drastically increasing in number. The elderly people tend tohave problems of diabetes or arteriosclerosis. Reduced or lossof walking function or ability could be the biggest impact 7),
which hinders opportunities of going out. A reduction ofopportunities for social contact could induce social isolation.
Consequently, not only walking function but also entire
physical activities functions are increasingly diminished 8).
In order to break this vicious cycle, continuous walking
exercise is effective for maintaining functional gait to improve
walking speed with eyes closed, extend stride length andshorten double leg supporting time 9, 10).
Remarkably beneficial effects can be exerted by walking
intervention programs to middle and senior patients with highblood pressure, metabolic disorder, locomotor disease andneurological disorder. Walking exercise has been reported tohave diverse effects such as the reduction of blood pressure
11, 12), the prevention of osteoporosis 13), the prevention offrailty or “ frail” in Japanese 14), the maintenance of a beautiful
posture 15), the improvement in leg muscle strength 9, 16),
the maintenance of good functional sense of balance 9, 17),
fall prevention 18, 19), relaxing effect 20), the improvement ofsubjective symptoms related to quality of life (QOL) 21), theimprovement of sleep quality and daytime sleepiness 22), as
has been reported.
From the viewpoint of glycative stress, it has beenreported that walking exercise interventions enable thereduction of postprandial hyperglycemia 23) and improved
neutral fat levels in blood 24). Specifically, walking exercise
greatly contributes to the reduction of glycative stress.

_ 13 9 _Special Insole Fitting and Walking Exercise

Table 7. EMG

Average Rectified Value

1 Erector spinae muscle

CV
Integrated value
Average Rectified Value

2 Gluteus medius muscle

CV
Integrated value
Average Rectified Value

3 Vastus medialis

CV
Integrated value
Average Rectified Value

4 Vastus lateralis

CV
Integrated value
Average Rectified Value

5 Soleus

CV
Integrated value
Average Rectified Value

6 Tibialis anterior

CV
Integrated value
Average Rectified Value

7 Tibialis posterior

CV
Integrated value
Average Rectified Valuearticlen

Average ± S D

Test article

60.333 ± 0.611

Control article

60.235 ± 0.398

Test article

60.837 ± 0.364

Control article

60.831 ± 0.316

Test article

639.974 ± 73.364

Control article

6

28.163 ± 47.804

Test article

60.124 ± 0.042

Control article

60.099 ± 0.055

Test article

6

1.682 ± 1.303

Control article

6

1.646 ± 1.106

Test article

614.824 ± 5.041

Control article

6

11.891 ± 6.645

Test article

60.184 ± 0.121

Control article

60.148 ± 0.108

Test article

6

1.386 ± 0.337

Control article

6

1.432 ± 0.480

Test article

6

22.116 ± 14.535

Control article

617.819 ± 12.939

Test article

60.060 ± 0.028

Control article

60.053 ± 0.018

Test article

6

1.296 ± 0.317

Control article

6

1.356 ± 0.261

Test article

67.236 ± 3.330

Control article

66.387 ± 2.146

Test article

60.117 ± 0.028

Control article

60.131 ± 0.039

Test article

6

1.547 ± 0.207

Control article

6

1.516 ± 0.138

Test article

6

13.994 ± 3.419

Control article

615.750 ± 4.643

Test article

60.085 ± 0.031

Control article

60.086 ± 0.036

Test article

6

1.091 ± 0.246

Control article

61.173 ± 0.279

Test article

6

10.193 ± 3.764

Control article

610.302 ± 4.261

Test article

60.086 ± 0.013

Control article

60.092 ± 0.024

Test article

6

1.437 ± 0.193

Control article

6

1.479 ± 0.145

Test article

6

10.371 ± 1.519

article_ 14Control
0 _6

11.063 ± 2.902

Test article

6

0.085

0.033

Control article

6

0.083

0.030

p value*0.0460.938* 0.046
0.109
0.463
0.109
0.127
0.916
0.127
0.240
0.443
0.240
0.262
0.532
0.262
0.916
0.916
0.916
0.427
0.463
0.427
0.770

Integrated value
Average Rectified Value

6 Tibialis anterior

CV
Integrated value
Average Rectified ValueCV

7 Tibialis posterior

Integrated value
Average Rectified ValueCV

8 Peroneus brevis

Integrated value

0.262

Control article

615.750 ± 4.643

Test article

60.085 ± 0.031

Control article

6

0.916
Glycative StressResearch
0.086 ± 0.036

Test article

6

1.091 ± 0.246

Control article

61.173 ± 0.279

Test article

6

10.193 ± 3.764

Control article

610.302 ± 4.261

Test article

60.086 ± 0.013

Control article

60.092 ± 0.024

Test article

6

1.437 ± 0.193

Control article

6

1.479 ± 0.145

Test article

6

10.371 ± 1.519

Control article

6

11.063 ± 2.902

Test article

6

0.085

0.033

Control article

6

0.083

0.030

Test article

6

1.400

0.193

Control article

6

1.374

0.172

Test article

6

10.161

3.906

Control article

6

9.929

3.618

0.916
0.916
0.427
0.463
0.427
0.770
0.674
0.770

Data are expressed as mean ± SD, Wilcoxon signed-rank test, n = 6. EMG, electromyography; CV, coefficient of variation; SD, standard deviation.

Furthermore, walking exercise contributes to sustaining
cognitive activity and mental function 1, 2, 25-28). Research of
exercise effects on young people demonstrated that a greaternumber of steps in walking induced greater effects on
cognitive function with a higher concentration of oxygenatedhemoglobin and a higher full-scale intelligence quotient,as was shown by a near infrared spectroscopy examination
for cerebral blood flow 26). A research advocated Cognicise
and/or Cogniwalk to sustain cognitive function and prevent
cognitive decline 29).
Transcervical fractures caused by falls have an adverse
effect on convalescence. Falls are likely to happen while
walking. There are risk factors of fear for having a fallamong aged persons, especially women 30). It is important toremove fear, which requires starting to establish a walking
habit prior to senescence.
The research participants of this study were residents
in or around Kanazawa City. Epidemiological data indicatesthat the number of daily steps in walking is different,
depending the scale of cities; in both males and females,
which were age-adjusted. Persons living in a smaller-sizedcity tend to have the smaller number of steps 31). To specify
some negative determinants of physical function, there is
low population density, low land use mix score, and fewer
daily life-related destinations such as community centers,
medical facilities and recreational facilities 32). Furthermore,
public transportation systems are difficult to develop
in smaller cities, which generally has a car-dependentcommunity. The research participants of this study werepersons living in an area where the number of daily steps israther small.

Exercise and growth hormone (GH)Health-promoting lifestyle behavior involves the
improvement of dietary, physical and intellectual education.
Physical education, which means exercise therapy, contains

stretching exercises, aerobic exercises and muscle training.
The points of attention in the exercises are to keep balance
without inclination in practicing these exercises and to
avoid an excessive amount of exercise. One of the exercise
effects is to promote GH secretion 33 -36). The secretion of
GE is frequently applied as an index to evaluate the amountof exercise or physical activity 37- 42). Compression Strength
Training, or KAATSU training has been developed to obtain
efficient GH secretion 35, 43-45).
This research was conducted, referring our previous
research, successfully to employ glucose load; 40 g of glucose
oral load was provided to subjects approximately 1 hour
before walking. In the previous research regarding adumbbell exercise, a problem occurred where female subjects
had shown a GH stimulated secretion before the test and noincrease of GH level had been shown from the exercise in
the GH stimulation test. In the present research, glucose load
enabled to set GH values at a low level prior to the walking
exercise. The function of GH stimulated secretion wasrecognized even due to a low-load exercise of a 30-minutesof walking. Cases where GH values were not recovered withglucose load were eliminated. However, possibilities of GH
hypersecretion due to hypophyseal adenoma or hyperplasia
cannot be excluded and further minute examinations such as
MRI will be requested.

Anti-aging medical checkup

Anti-aging medical checkups or examinations are aneffective method to evaluate physical conditions of theelderly, not only as indicators of aging-related of whole body,
but also as a balance among diverse functions 46 - 48).
We provided a 6-month walking intervention program toworkers of an enterprise, lending a pedometer and confirming
the total number of steps every month. Two anti-aging
checkups were performed before and after the intervention.
Results of the checkups indicated the reduction of weight,_ 141 _

Special Insole Fitting and Walking Exercise

body mass index (BMI), blood pressure, LDL-C, fasting
insulin level (improvement in insulin resistance), and IGF-I 49).
The decrease of IGF-I was interpreted to be triggered where
the increase of insulin resistance had induced the conditionof the compensatory increase in insulin secretion, but theexercise intervention resulted in a compensatory reduction in
IGF-I. We also conducted a similar intervention and researchin another factory, examining the effectiveness of the walking
exercise 50).
Our research center started to conduct a walking
intervention program with pedometer-based management in
the Yurin area of Shimogyo-ku, Kyoto, Japan in Decemberof 2008 and evaluated their physical conditions through antiaging medical checkups 51-53). The research participants ofthis exercise program, including people who joined midway,
were provided with a pedometer and instruction sheets
to be motivated by the intervention. A cohort study 52) was
conducted for the participants for two and a half years to
examine the physical influences of the walking program
employing a pedometer 51). Our project clarified the importanceof physical activities for the elderly. Our research center had
conducted preceding research examining the association
between the number of steps and the amount of physicalactivities 53). It was demonstrated that the elderly participantsof this program were maintaining a physical level ofactivity which was almost identical to the level of adult
physical activity recommended by the Ministry of Health,Labour and Welfare guidelines. It was also shown thatindependently-living elderly people were significantly
younger in neural functional age than support- or nursingrequiring elderly people 48). It is important to lead a mentallyand physically active life, remaining healthy in neuralfunction, in order to be an elderly person requiring no
nursing care.
From the viewpoint of anti-aging, it can be recognizedthat walking exercise contributes to the health promotion forworkers or the elderly, the prevention of dementia and the
reduction of glycative stress.

Research on footwear, shoes and insoles

Research on the influences of footwear or foot carehas been actively conducted in Japan recently. However,
little interest or awareness on foot care was shown in a
consciousness survey by the elderly 54). Other than theaccumulation of research findings, publicity is necessary to
promote walking exercise. To encourage elderly persons tobe aware of the importance of foot care, concrete methodsof care for the sole and toe of the foot must be introduced
through mass media.
Biomechanics of the feet is a matter of concern andinterest to all people related to insole therapy. Conventionally,
the foot was regarded as a single segment in the field ofbiomechanics. However, state of the art technologies haveenabled more precise measurement to divide a foot into
multiple zones and to acquire information that is distinguishedfrom the conventional measurement. As a matter of fact, what
is important for healthy walking, from the viewpoint of threedimensional motion analysis, is the movement of the sagittal
plane rather than pronation/ supination and adduction/
abduction 55). It has been recognized that important factors
are not only movement of the rearfoot, which is frequently
regarded as an observation point clinically, but also theforefoot and midfoot.

It is important to establish an assessment method tocompare and examine the effects of shoes 56 -59). This study
examined the amount of muscle movement of lower limbs
employing a multi-channel surface EMG, though subjects
were different. Characteristics of muscle activities can beevaluated in various parts of the legs 60 - 62).
Matched or mismatched shoes influence standing postureor walking 63, 64). The functions of legs, especially in elderly
persons, are reduced and are more likely to be influenced
by shoes. Appropriate selection and wearing of shoes could
prevent the elderly from falling or having disorders of the leg
and feet 64). Many females experience foot pain due to highheeled shoes. Even low-heel shoes could cause pain when
they are mismatched to feet. Many females seek a pair of
ideal shoes that meet their conflicting desires. Shoes must be
stylish and fashionable and at the same time, functional andcomfortable. However, to prevent foot trouble, it is necessary
to chose suitable shoes for their own use and to wear themin an appropriate manner. The keys to choosing shoes are as
follows: To know how to measure feet, foot length and footcircumference, to confirm whether pressure is intense on thehallux (first toe) or the metatarsophalangeal (MTP, little toe)joint, which is likely to induce pain when wearing shoes, toconfirm whether space is left in the toe of a shoe, to confirm
whether the arch of the shoe fits the medial longitudinalarch of foot, and to confirm whether heels are stable. It is
important to select shoes depending on the situation 63, 64).
One of the methods to solve a problem of mismatchedshoes is to use insoles. Insoles are used to feel comfortable,
to prevent shoe sores or blisters and to relieve arthralgia painof the knees or ankles. It is possible to be closer to the ideal
shoes by fixing a mismatch with the appropriate insoles.
Shoes consist of the upper and the sole. The upper
requires proper fitting and durability, and diverse materials
for the upper have been developed. A heel counter functions
to support calcaneal and to prevent excessive pronation. The
sole contacts the ground, which requires shock absorption
and durability. A shank of the sole enhances stability. It isvital to understand the structures of shoes and the relation tohuman functions and diseases 65). Insoles are placed between
the upper and the sole.
Insoles are used for the conservative treatment of hallux
rigidus 66), the increase of plantar and dorsal flexor muscle
strength 67), the improvement of muscular activity andbalancing sense, the relief of plantar region pain 68), thecorrection of floating toe 69), the relief of sacroiliac pain ofpatients with sacroiliac joint dysfunction 70) and the correctionof flatfoot 71), as reported. In walking of a patient withosteoarthritis (OA), the movement distance of the reverse
response phenomenon at the start of the walking motion
is shorter than a healthy person and waveform pattern has
different tendencies 71). Research demonstrated that usage ofappropriate therapeutic insoles is effective for patients withosteoarthritis (OA), as a center of pressure (COP) movement
distances tend to alter in the crosswise and anterior directions
72). In cases where insoles are not matched well, effects
cannot be detected 61).

Effects of sand beach walkings

The first thing that we did for the development of theinsole is to have an image or a concept of sand beach walking.
While your foot sinks into sand and your foot and leg muscles
work extra hard with load, you feel comfortable and you are_ 14 2 _Glycative Stress Research

lifted up. We intended to develop insoles for this goal.
Effects of sand-walking are to improve metabolicsyndromes-related factors 73), which are indicated by triglycerideand visceral fat, insulin resistance and arterial stiffness.
Other than that, sand walking can reduce mental and physicalstress 74, 75) and lower blood pressure 75), as has been reported.
Previous research demonstrated that in comparison towalking on a paved street, sand walking has diverse effects
such as the promotion of cardiac rate and calorie consumption,
the decrease in body fat percentage, hypotensive action,
the increase in plantar flexor muscle strength and knee
extension force, the improvement of balance-function and theimprovement of aerobic work ability 77, 78).
Some research indicated that psychological influences ofwalking intervention, such as entertainment 79) or fulfilment 80),
could be encouraging to enhance social adaptability andsociability rather than the amount of exercise load in walking.
Sand-walking would apparently be more entertaining thanwalking on a paved street.
These days a multi-channel surface EMG analysis
enables us to clarify conditions of various muscle group
activities showing how the activity amounts of walkingrelated muscles change along with changes in steps per
minute, how a forward-inclining-posture gait influences
walking and what differences are between the elderly and the
young 81- 83). In the gait-patterning mechanisms of humans,
their comfortable steps per minute and walking speed arenaturally determined 82). There has not yet been reported
research information on electromyogram of sand-walking,which is anticipated and would be very interesting.
What would the EMG waveform of sand-walking be?
The following is our hypothesis. Sand-walking is fatiguing,which is induced by muscle fatigue. The amount of muscle
activity of walking in sand must be greater than walking
on paved ground. The sinkages both in landing and kicking
up are the key factor. Extra load is imposed on the muscle
group of the lower limbs. Furthermore, unstable sandy
soil adds extra load on erector spinae muscle (tension ofmuscle) for postural stability. However, walking around abeautiful beach is pleasant and entertaining. Satisfaction andfulfilment are gained. People feel comfortable due to thesetypes of stimuli to the brain reward system, even thoughsand walking is an exercise with heavy load on muscles,
which is not energy efficient.
This study revealed that the amount of activity inthe erector spinae muscle was greater when using the test
product through analysis results of multi-channel surface
EMG. Erector spinae muscles play an important role forpostural stability and is a large mass consisting of threegroups, spinalis muscle, longissimus muscle and theiliocostalis muscle.
Although it was conjectured that the effects of sinkage
in walking were reflected by the usage of insoles, there wasno significant difference in the amount of muscle activity inthe lower thigh. However, it was recognized that a load was
imposed on musculus erector spinae for posture stability.
There is a possibility that effects similar to sand-walking
were obtained. More mental effects with pleasure could beachieved when shoes are both comfortable and fashionable.
Direction of our attempt with the concept and goal of“walking on a sandy beach” is in a proper course to develop
comfortable insole products.

Safety assessment
There were no adverse events attributable to this study
with using the test article. It was shown that there were no
problems in safety. Contrarily, shoe sores or friction blisters
were recognized as an adverse event ( 7 out of 12 subjects,
incident rate 58.3 %) in the group with the control article. It
was assumed that using the test article, the proper insoles
enabled the reduction of frictional force against foot skin andprevented adverse events.

Research limitation

This was study conducted as an open trial to examine thesame subjects twice. The production of specially processed
insoles was time and energy consuming, which requires
fine tuning until just before the start of the test. Thus, acrossover trial was unable to be performed. Influences fromthe examination timing could be contained in the data. It
was possible that the GH secretion activity by the exercise
load was weaker in the test article in the second term of
the examination than in the control article in the first termof examination. It is assumed that the second effect (theresponse reaction to stimuli is weaker in the second time thanin the first time) resulted in the influence where GH secretiontended to be smaller in the second term of wearing the test
article than in the first term of wearing the control article.

Conclusion

The examination of exercise effects of the test article,
specially processed insoles, which performed in an open
trial with 12 healthy female subjects, suggested a possibility
that this insole test product had a load training effect onlower thigh muscles and few adverse effects are expectedfrom its use.

Conflict of interest statementLtd.

_ 143 _The present study was sponsored by ASICS Trading Co.

Special Insole Fitting and Walking Exercise

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