Shinshu Med J, 72⑷：239～249, 2024

Impact of Ao-dake-humi, a Japanese Traditional Bamboo Foot Stimulator,
on Lower Urinary Tract Symptoms, Constipation, Insomnia, andHypersensitivity to Cold in Elderly People
Manabu Ueno, Tomonori Minagawa＊, Tomonori Kurita, Yoshihiro Inoue
Masashi Shiozaki, Noriyuki Ogawa, Hiroaki Hara and Teruyuki Ogawa
Department of Urology, Shinshu University School of Medicine

Background : Ao-dake-humi (ADH) is a traditional Japanese bamboo foot stimulator that is commonly used topromote general health among the elderly in Japan. Our earlier report revealed that ADH could improve lower
urinary tract symptoms (LUTS), constipation, and hypersensitivity to cold (HC). This study investigated the precise effects and mechanisms of ADH on health in elderly people.
Methods : In this multi-center, randomized, crossover trial, a simple stepping exercise (SSE) was adopted as acontrol to exclude the exercise effects of ADH. Elderly people over 60 years of age with clinically diagnosed
LUTS, constipation, insomnia, or HC were enrolled. ADH or SSE activities were performed twice a day for 28
days. Before and at 28 days of each regimen, International Prostate Symptom Score (IPSS), Athens Insomnia Scale(a visual analogue scale for constipation and HC), and defecation frequency measurements were assessed forcomparisons. After the 28 days of initial treatment, ADH and SSE activities were crossed for each other, and thena second intervention was carried out for 28 days.
Results : Of the 37 elderly people (6 male and 31 female) enrolled in the study, 25 participants (4 male and 21 female) were ultimately analyzed. IPSS results improved significantly after ADH. Moreover, ADH ameliorated insomnia and HC significantly more in comparisons with SSE. Constipation status findings were comparable between ADH and SSE.
Conclusions : ADH may have a therapeutic advantage over SSE for the management of LUTS, insomnia, andHC, possibly through the mechanism of physical foot stimulation as a neuromodulator. Shinshu Med J 72 : 239 ―
249, 2024(Received for publication January 17, 2024 ; accepted in revised form April 15, 2024)
Key words : ao-dake-humi, lower urinary tract symptoms, constipation, hypersensitivity to cold, insomnia
Abbreviations : ADH, ao-dake-humi ; AIS, Athens Insomnia Scale ; FAS, full analysis set ; HC, hypersensitivity
to cold ; IPSS, International Prostate Symptom Score ; LUTS, lower urinary tract symptoms ; OABSS, Overactive
Bladder Symptom Score ; QOL, quality of life ; SSE, simple stepping exercise ; VAS, visual analogue scale
Ⅰ Introduction

stepping on. ADH is commonly employed to promote
general health among the elderly in Japan (Fig. 1A).

Ao-dake-humi (ADH) is a traditional Japanese footWe earlier reported that ADH displayed therapeuticstimulator consisting of a half-pipe-shaped step madeeffects on lower urinary tract symptoms (LUTS), con-of bamboo that is used to stimulate the foot by being

stipation, and hypersensitivity to cold (HC) as a type of＊Corresponding author : Tomonori Minagawa
Department of Urology, Shinshu University School of
Medicine, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
E-mail : minagawat@shinshu-u.ac.jp

No. 4, 2024

neuromodulator via physical stimulation of the foot1）.
Since ADH is effective, safe, portable (290 g), and lowcost (approximately 5 USD), it may have clinical use ingeneral health promotion among the elderly at nurs239

Ueno・Minagawa・Kurita et al.

Fig. 1 Photo and use of ao-dake-humi(A) Photo of ao-dake-humi.
(B) Use of ao-dake-humi. Ao-dake-humi
can stimulate the foot by being stepping
on repeatedly.

ing homes. We conducted the present trial to examinewith the standards of the Ethics Committee of Shins-

the precise effects and mechanisms of ADH on thehu University School of Medicine, the Helsinki Decla-

health status of elderly people.

ration of 1975 (2008 revision), and the Ethical Guide-Ⅱ
Ａ

Materials and Methods

Study design
This was a multi-center, randomized, open-label,lines for Clinical Studies issued by the Ministry of
Health, Labor, and Welfare of Japan, which were revised in 2008 and enforced in April 2009. Permission
number was 3303-2015 (accepted : November 4, 2015).

crossover trial that was conducted at among 7 nursing

Trial registration number was UMIN000023382.

homes in Japan. As the therapeutic mechanisms ofＣ

Participants

ADH may include exercise in addition to stimulation

Elderly adults over 60 years of age clinically diag-akin to a foot massage or neuromodulator, simple step-

nosed as having LUTS, constipation, insomnia, or HC

ping exercise (SSE) on a flat floor was employed as a

for at least 1 year or were randomized into 2 groups.

control to exclude the exercise effects of ADH. The

Screening was done by means of questions by nurses

impact of ADH and SSE on health was comparedat each institution. Participants were excluded if theyusing established questionnaires.

could not walk by themselves or if they had dementia,

Ｂ

performance status≧3, paralysis, bone fracture in the

Ethical statement
All study procedures were carried out in accordance
240

extremities, or severe neuropathy. Subjects with probShinshu Med J

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Impact of ao-dake-humi on LUTS

lems walking or who received regular foot massages

ADH used in this study was made of bamboo, 40

or other forms of foot stimulation were also excluded.

cm in length, 8.5 cm in width, 4.5 cm in height, andAll participants were included in the safety analysis

almost 290 g in weight. All of ADH was unified intoset (SAS) unless they withdrew informed consent.

the same size by Taketora Co. (Osaka, Japan).

The full analysis set (FAS) included participants who

Ｅ

Questionnaires

performed both ADH and SSE after registration. Par-

Before and 28 days after starting ADH or SSE, In-ticipants were excluded if : (i) they withdrew informed

ternational Prostate Symptom Score (IPSS), Quality

consent at any time during the trial ; (ii) they wereof Life (QOL), and Overactive Bladder Symptom Score

judged as ineligible after registration ; or (iii) they were

(OABSS) assessments were conducted to compare

missing baseline data. Moreover, people with severe

the impact of ADH and SSE on LUTS. Athens In-

digestive diseases were excluded. In addition, changesomnia Scale (AIS) was used to evaluate the efficacy

of medical management about LUTS, constipation, andof ADH on insomnia. A visual analogue scale (VAS)

insomnia were not permitted during this trial, and a

was employed to determine the effect of ADH on con-participant who needed change of medical manage-

stipation (VAS-constipation) and HC (VAS-HC) inment about LUTS, constipation, and insomnia was ex-

participants with constipation or HC, respectively.

cluded from the final analysis.

Defecation frequency per week was also ascertainedＤ

to evaluate the impact of ADH on constipation. All ofProtocolADH and SSE were performed at each participat-

the questionaries were collected by the facility direc-

ing nursing home. After obtaining a consent for thistors in the end of each term. Finally, all of the data

trial, eligible participants were randomized at a 1 : 1

was collected and analyzed by a single analyzer.

ratio into the ADH preceding group and the SSE pre-Ｆ

Sub-analysis

ceding group using the envelope method. ADH andParticipants with no or mild symptoms were ex-

SSE were performed twice a day, in the morning

cluded from the sub-analysis protocol. Moderate or

and evening, for 28 days. After 28 days of the initial

severe symptoms were defined as IPSS≧8, QoL≧2,treatment, the ADH and SSE activities were crossed

OABSS≧6, AIS≧4, VAS constipation≧1/10, and VAS-

with each other and performed for another 28 days.

HC≧1/10, defecation frequency≦6/week. Delta (Δ)

All kinds of questionaries were obtained from all ofmeans change from the baseline value. Separately,

the participants prior to the beginning of this trial

Moderate and severe symptoms rate were calculated

and the end of each activity. Wash-out period wasin the baseline values and the values after ADH andnot set because foot stimulation may not affect for a

SSE conditions.

long time. All of the self-administrated questionnaires

Ｇ

Achievement rate and safety

were collected by the facility directors in the end ofParticipants who felt pain could reduce their exercise

each term. Finally, all of the data was collected andfrequency use from twice to once a day. The achieve-

analyzed by a single analyzer. The duration of ADH

ment rates of ADH and SSE were tracked using a(for 28 days) was set in accordance with our previ-diary to clarify the intervention adherence and po-

1）

ous report . Moreover, 28 days may be appropriate

tential harmfulness of ADH. All participants record-for evaluation of short time effects of LUT therapy.

ed ADH and SSE as “done” or “none” in the diary.

Holding something such as the wall, desk, or pillar,

The total practice rate (number of sets performed /the participants placed the arches of both feet on the[2 sets×28 days]) was calculated for all participants.

ADH instrument and made repeated steps for 2 minAdverse events were also evaluated during the trial.

in a set, as shown in Fig. 1B. SSE was done in a com-

All adverse events occurring after the commence-parable manner. In accordance with the conventional

ment of ADH or SSE were reviewed to evaluate theuse of ADH, steps were made 30-60 times/min at asafety of the activities. The occurrence and severity

pace controlled by the participants themselves.

of such events were evaluated for each patient, with

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Ueno・Minagawa・Kurita et al.

Fig. 2＊Distribution of participants throughout the study

A total of 25 participants completed all protocols of the study.

causality between ADH or SSE and the adverse event

Moreover, correlation between treatment effects andjudged by investigators at the respective institution.

age/achievement rate was evaluated considering dif-Ｈ

ference of physiological function among elderly peo-

Statistical analysis
The efficacy of the activities was evaluated using

paired participant data between baseline and at 28

ple. A correlation of 0.4 or -0.4 was treated as a moderate correlation.

days of ADH or SSE as all end-points. Data were

Ⅲ Results

expressed as the mean change value from baseline±
standard deviation. Data were analyzed using theＡ

Participants

Excel-based statistical program file Excel TouKei

The distribution of the participants throughout the(Social Survey Research Information Co., Ltd., Tokyo,

study is shown in Fig. 2. Twenty of the participants

Japan), with p＜0.05 indicating statistical significance.

were distributed into the ADH preceding group, andChanges between before and after ADH and SSE

17 participants were distributed into the SSE preced-

were analyzed using paired Mann-Whitney U test.

ing group. A total of 37 elderly people (6 male and 31

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Impact of ao-dake-humi on LUTS
Table 1

Characteristics of the enrolled patients in this study
All participants

ADH proceeding group

SSE proceeding group

25

14

11

4
21
80.8 ± 8.0

1
1380.0 ± 7.9

3881.7 ± 8.0

13
9
3

8
5
1

5
4
2

7
3
2
1

3
2
0
1

4
1
2
0

3
3
2

2
2
2

1
1
0

N
GenderMale
FemaleAge
Performance status
0
1
2
Past medical history
Hypertension
Diabetes melitus
Cerebral infarction/ bleeding
Heart desease (Hert infarction, angina, etc.)
Medication
Drug for LUTS
Drug for constipation
Drug for insomnia

ADH : Ao-dake-humi, LUTS : lower urinary tract symptoms, SSE : Simple Step Excersize
Table 2
All patients(N＝25)N

Mean ± SD
8.3 ± 6.1
2.7 ± 2.62525

4.8 ± 3.3
0.8 ± 1.2

QOL score
OABSS

22
25

3.1 ± 1.8
3.4 ± 2.4

AIS
VAS-constipation
VAS-hypersensitivity to cold
Frequency of defecation

25
24
23
23

4.6
2
3.6
6.5

IPSS storage subscore
IPSS postvoiding subscore

±
±
±
±

ADH proceeding group(N＝14)

Mild-severe symptom patients

25
25

IPSS total score
IPSS voiding subscore

Baseline data of enrolled patients

3
2.2
3.2
3.1

SSE proceeding group(N＝11)

p valueN

Mean ± SD

N

Mean ± SD

N

Mean ± SD

121212.9 ± 5.5
4.3 ± 2.4

14
14

10.3 ± 7.3
3.0 ± 3.1

1111

7.7 ± 4.3
2.6 ± 1.7

0.978
0.547

12
12

7 ± 3.2
1.7 ± 1.3

1414

6.2 ± 3.8
1.0 ± 1.51111

4.3 ± 2.5
0.8 ± 0.9

0.681
0.622

(QOL ≧ 2)(OABSS ≧ 6)

145

3.8 ± 1.5
7.8 ± 1.31114

3.2 ± 3.0
3.0 ± 1.6911

3.2 ± 2.0
3.8 ± 3.1

0.483
0.661

(AIS ≧ 4)(VAS ≧ 1/10)(VAS ≧ 1/10)(≦ 6/week)

14
13
14
11

6.4
3.7
5.7
4.1

14
14
14
13

4.6
2.1
3.6
5.8

11
10
9
10

4.5
1.9
3.5
7.4

0.494
0.639
0.208
0.227

(IPSS ≧ 8)

±
±
±
±

2.9
1.7
2.2
1.3

±
±
±
±

3.6
1.8
2.9
2.3

±
±
±
±

2.2
2.6
3.6
3.6

ADH : Ao-Dake-Humi, AIS : Athens Insomnia Scale, IPSS : International Prostate Symptom Score, OABSS : Overactive Bladder Symptom Score,
QOL : quality of life, SD : standard deviation, SSE : Simple Step Exercise, VAS : visual analogue scale

female) were enrolled in the SAS. Six participants dis-

Ｂ

Questionnaire results

tributed into ADH preceding group and 6 participants

The results of the FAS are presented in Table 3.

distributed into SSE preceding group were excluded

ADH significantly improved the total score of IPSS,

for protocol violation, patient decision, flu-infection,

IPSS storage subscore, QOL score, OABSS, AIS, andand unknown reason. Ultimately, 25 participants (4VAS-HC, whereas SSE ameliorated QOL score only.

male and 21 female, mean age : 80.8 years) were eval-

IPSS voiding subscore, OABSS, AIS, and VAS-HC

uated in the FAS. The clinical characteristics of theafter ADH were significantly better than after SSE.

enrolled participants for both safety and efficacy anal-

The results of the sub-analysis of participants withyses are shown in Table 1. The baseline values frommoderate or severe symptoms are shown in Table 4.

questionnaires are summarized in Table 2 along with

ADH significantly improved the results for IPSS,

those of the participants with moderate to severe

QOL, OABSS, AIS, and VAS-HC, while SSE signifi-

symptoms.

cantly ameliorated IPSS, IPSS storage subscore, IPSS
postvoiding subscore, QOL, and VAS-HC results. A

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Ueno・Minagawa・Kurita et al.
Table 3 Subjective effects of ao-dake-humi on lower urinary tract symptoms, insomnia, hypersensitivity to cold,and constipation. Different before and after ao-dake-humi was shown
ADH condition

SSE condition

N

Mean ± SD

p-value(before-after)

Mean ± SD

25-2.4 ± 5.5

0.0222＊IPSS voiding subscore25-0.8 ± 2.4

0.0541-1.5 ± 5.5-0.4 ± 2.5

0.09850.2391

0.05100.0388＊IPSS storage subscore
IPSS postvoiding subscore
ΔQoL score

25
25
25

-1.3 ± 3.0-0.3 ± 0.9-0.7 ± 1.5

0.0246＊
0.07390.0245＊-0.8 ± 2.9-0.3 ± 1.2

0.08390.12220.07060.5000-0.8 ± 0.9

0.0481＊0.4267＊0.0 ± 2.1

0.46270.0379＊ΔIPSS
Total score

p-valuep-value(before-after) (ADH vs SSE)ΔOABSS19-1.1 ± 2.7

0.0288ΔAIS

25-1.0 ± 2.8

0.0449＊-0.4 ± 2.4

0.2376

0.0460＊＊-0.4 ± 2.8

0.24530.0166＊0.1 ± 1.7
0.6 ± 2.4

0.43570.12430.12000.1294

ΔVAS-hypersensitivity to cold

23

-1.2 ± 3.1

0.0435

ΔVAS-constipation
ΔFrequency of defecation

24
23-0.4 ± 1.5
0.9 ± 2.6

0.13150.0571＊: p＜0.05, ＊＊p＜0.01.ADH : Ao-Dake-Humi, AIS : Athens Insomnia Scale, IPSS : International Prostate Symptom Score,
OABSS : Overactive Bladder Symptom Score, QOL : quality of life, SD : standard deviation, SSE : Simple Step Exercise,
VAS : visual analogue scale. Delta (Δ) means change from the baseline value.

Table 4 Subjective effects of ao-dake-humi on moderate or severe symptoms, lower urinary tract symptoms,
insomnia, hypersensitivity to cold, and constipation. Different before and after ao-dake-humi was shown
ADH condition

ΔIPSS
Total score

SSE condition

N

Mean ± SD

p-value(before-after)

Mean ± SD

12-4.6 ± 6.3

0.0164＊-3.8 ± 5.9

0.0283＊0.1814＊-1.0 ± 2.6

0.10440.1281p-valuep-value(before-after) (ADH vs SSE)

IPSS voiding subscore12-1.5 ± 2.7

0.0429IPSS storage subscore12-2.3 ± 3.3

0.0194＊-1.7 ± 3.1

0.0457＊0.119312-0.8 ± 1.1

0.0217＊-1.0 ± 1.2

0.0076＊＊

0.0955ΔQoL score14-1.1 ± 1.6

0.0147＊ΔOABSS
ΔAIS

5
14-4.2 ± 3.9-1.6 ± 2.9

0.0478＊0.0326＊-1.3 ± 2.3-0.6 ± 1.2

0.0315＊0.18700.30430.0780-1.2 ± 2.5

0.05070.2216

ΔVAS-hypersensitivity to cold

14

-2.6 ± 2.8

0.0027＊＊

ΔVAS-constipation

13-0.6 ± 2.0

0.1565-1.6 ± 2.4-0.1 ± 2.2

0.0160＊0.42100.23130.0409＊

ΔFrequency of defecation

11

1.6 ± 3.3

0.08391.1 ± 3.3

0.15740.0881

IPSS postvoiding subscore＊＊＊: p＜0.05,
p＜0.01. ADH : Ao-dake-humi, AIS ; Athens Insomnia Scale, IPSS ; international prostate symptom score,
OABSS ; overactive bladder symptom score, QOL ; quality of life, SSE : symple step excercise, VAS ; visual analogue scale.
Moderate or severe symptoms were defined as IPSS ≧8, QoL ≧2, OABSS ≧6, AIS ≧4, VAS constipation ≧1/10, and
VAS hypersensitivity to cold ≧1/10, defecation frequency ≦6/week. Delta ( △ ) means change from the baseline value.

significant difference was seen for VAS-constipation

Ｃ

Achievement rate and safety

among the conditions. Comparing moderate and se-

The achievement rate for ADH and SSE was 92.7

vere symptoms rate, the values after ADH condition％ and 91.7 ％, respectively, according to participant

were generally less than those after SSE condition

diaries. During the study period, 5 participants suf-

besides QOL (Fig. 3).

fered influenza infection and dropped out the protocol. Those events were not considered adverse ef-

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Impact of ao-dake-humi on LUTS

Fig. 3 Moderate and severe symptoms rate. Percentage of participants number with moderate and severe symptoms
were shown. Moderate or severe symptoms were defined as IPSS≧ 8, QOL≧ 2, OABSS≧ 6, AIS≧ 4,
VAS constipation≧1/10, and VAS hypersensitivity to cold≧1/10, defecation frequency≦6/week.
Delta (Δ) means change from the baseline value.

Table 5

Correlation between treatement effects and age/achievement rate
Effects & Age

Effects & Achievement rate

ADH condition

SSE condition

ADH condition

SSE condition

r

p

r

p

r

p

r

p

IPSS total
QOL scoOABSSAIS
VAS-con
VAS-hyp-0.082-0.3240.466
0.315-0.103-0.042

0.400
0.094
0.809
0.862
0.370
0.444

-0.014-0.053-0.191
0.495-0.052-0.449

0.483
0.435
0.372
0.962
0.433
0.056

0.288
0.077
0.737
-0.013-0.170-0.476

0.818
0.618
0.956
0.483
0.308
0.059

-0.0630.105
0.311-0.115-0.734-0.166

0.422
0.659
0.708
0.354
0.004
0.303

Frequency of defecation

0.501

0.944

0.479

0.934

0.280

0.771

0.285

0.775

ADH : Ao-Dake-Humi, AIS : Athens Insomnia Scale, IPSS : International Prostate Symptom Score, OABSS : Overactive
Bladder Symptom Score, QOL : quality of life, SD : standard deviation, SSE : Simple Step Exercise, VAS : visual analogue scalefects of ADH or SSE. No other adverse events wererevealed in all of the conditions. Moreover, correlation

recorded among the participants.

with treatment effects was revealed about OABSSＤ

and VAS-HC after ADH without statistic significant,Correlation
Moderate correlations with age were found in OABSSand frequency of defecation after ADH condition, andwhereas VAS-constipation after SSE with statistic
significant.

AIS and frequency of defecation after SSE condition(Table 5). However, statistical significance was not
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Ueno・Minagawa・Kurita et al.

Ⅳ Discussion

elderly, who tend to suffer from fragmented, shallow
sleep and early morning awakening2）3）. In the FASThis trial was conducted as a randomized study toand the sub-analysis of participants with insomnia,

clarify the impact of ADH on general health in elder-

ADH significantly improved AIS results. We suspect

ly people using SSE as a control. With a mean age

that ADH may have an indirect effect on insomnia via

over 80 years, the cohort comprised very advanced

a decrease in nocturnal frequency, although further

age participants and had a female preponderance.

investigation is needed on the exact role of ADH on

Concerning results on LUTS in the FAS, ADH sig-

sleep.

nificantly improved total IPSS, IPSS storage subscore,

HC has been identified as an aging problem in Japa-

QOL score, and OABSS, whereas SSE ameliorated

nese traditional “Kanpo” medicine. For example, skin

QOL score only. The change in values after ADH

sensation, especially to cold temperatures, can be re-was statistically different for IPSS voiding subscorelated to urinary bladder function and is called “Hie-and OABSS between ADH and SEE conditions. In

Shou” in Kampo medicine. Hie-Shou can be translat-

the sub-analysis of participants with moderate or se-

ed as HC. HC induces several secondary symptoms,vere LUTS symptoms, ADH significantly improved

including urinary urgency4）5）. HC was evaluated as a

total IPSS, all IPSS subscores, QOL score, and OABSS,

therapeutic target of ADH in our earlier report. VAS-

with significant gains in total IPSS, IPSS storage sub-HC was improved after ADH in all subjects, and wasscore, IPSS postvoiding subscore, and QOL score seen

also ameliorated in the participants with HC in thefor SSE. ADH was significantly superior to SSE for

FAS of the present trial1）. Since SSE also improved

the recovery of voiding symptoms and OABSS. These

VAS-HC in participants with HC, however, it might

results indicate that ADH may improve the storage

be considered that this symptom can be improved

function of the urinary bladder in addition the effects

by exercise, with additional effects elicited by ADH.

of SSE exercise. On the other hand, moderate andIn the sub-analysis, statistical difference was demon-

severe symptoms rate decreased after ADH condi-

strated only in VAS-constipation among the partici-

tions, especially in OABSS. These results indicatedpants with moderate or severe symptoms. Consider-that ADH can attenuate these symptoms more thaning the therapeutic effects of ADH on IPSS voidingSSE.

sub-score, OABSS, AIS, VAS-HC more than SSE

No significant differences were seen before andamong FAS (n＝25), ADH may not have sufficient

after ADH or SSE regarding constipation in the FAS.

effects on patients with moderate or severe symp-

In the sub-analysis of participants with constipation,

toms. Even if ADH do not have strong therapeutic

the change in VAS-constipation after ADH was sta-effects, ADH may have several benefits, such as costtistically greater than after SSE. The frequency ofand safety, for elderly people with chronic organ dis-

defecation did not change in any condition. Thus, theorders.

role of ADH on constipation was not confirmed in

Moreover, we found inconsistent results about cor-

this trial. Although ADH was effective to manage

relation between treatment effects and age/achieve-

constipation in our previous report, therapeutic effects

ment rate. These results indicate achievement rate ofof ADH were not revealed in this trial. This discrep-

both of ADH and SSE may increase the effects ofancy may come from the patient background in thistreatment on some symptoms. However, the obtained

trial. Elderly people were aimed in this trial on the

results are not consistent among the analytical meth-assumption that constipation is commonly troubled

ods. The further investigation should be arranged

among elderly people. Actually, constipation is not so

considering age and achievement rate dependency.

common and severe in this trial. That may be cause

Considering change of physiological function amongon the results about effect of ADH about constipation.

elder people, negative correlation was assumed prior

Insomnia is also a common problem among theto this trial. However, correlation with significance246

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Impact of ao-dake-humi on LUTS

was not found among age and treatment effects.

vation18）19）. In this view point, ADH can be treated as

Sample size might affect the results, and further in-a kind of self-foot-massage equipment. Therefore,vestigation should be done to confirm aging effects

ADH may affect peripheral vasodilator action andon ADH and SSE conditions.

mental relaxation from parasympathetic nerve sys-

Our previous study, which was the first to reporttem, and improved sensitivity to cold and insomnia.

on the therapeutic effects of ADH, was conducted as

These mechanisms should be clarified using nervea prospective trial in refractory LUTS participantsand vascular monitoring in further investigations.

1）with or without constipation or HC . However, it was

Moreover, ADH can be used in a private space, anda single-center, single-arm, prospective pilot trial withthe rhythm, duration, and frequency can be controlledinsufficient evidence to address the mechanisms ofby the user. ADH also appears adequate for extended

ADH. Therefore, the present investigation was de-treatment as a neuromodulator. However, the exact

signed as a crossover controlled trial, which employedrole of ADH has still been unknown well including

simple exercise as a control to exclude its effects onendurance after interruption of ADH and timing to

LUTS and other pathological conditions. We hypoth-show the effects of ADH. Therefore, further investi-

esized that ADH might represent a form of neuro-

gation should be done to clarify the effects of ADH inmodulation. Neuromodulation incorporates electricaldetail.

stimulation of specific nerves that control LUTS and

The effect of exercise should be considered whenan overactive bladder. The mechanism of neuromod-

speculating on the mechanisms of ADH as moving

ulation for LUTS is reportedly reflex inhibition of de-the leg muscles may promote blood supply and lymph

6）

trusor contraction by the activation of afferent fibers .

circulation in the pelvic organs. In this study, we used

Generating stimulation includes electrical stimulation,

SSE as a control to exclude the exercise effects ofinterferential therapy, and magnetic stimulation for

ADH. ADH showed significantly superior effects ver-

6）
-13）

afferent fiber activation. However, if the source ofsus SSE for several parameters apart from constipa-

neuromodulation is not stimulation, but rather rhyth-tion. Although attention is needed for a possible pla-

mic and repeated stimulation of afferent fibers, suchcebo effect, the results of this trial highlighted a roleforms of physical or mechanical stimulation like acu-of ADH in neuromodulation or additional effects topuncture, reflexology, and foot massage may constituteexercise via neural stimulation.

a source of neuromodulation. In fact, improvements

To the best of our knowledge, the present study isin overactive bladder and constipation by reflexology

the first randomized trial demonstrating the impact

14）
-16）

. ADH can thereforeof ADH on LUTS, constipation, HC, and insomnia in

be used for rhythmic, repeated, weight-dependentelderly people. However, it contained several limita-

physical stimulation of the feet without any additionaltions that must be considered when interpreting theequipment. Indeed, Sasaki et al. earlier reported that

results. First, the number of enrolled participants was“Aotake”, which was identical to ADH, improved lower-

limited. Especially, the effect of ADH on constipation

17）

extremity function as compared with walking exercise .

may be clarified using a larger cohort, although sig-

Those results indicated that ADH might impart ad-nificant differences were observed. Such findings will

ditional effects for promoting physical ability in the

support the role of ADH on promoting general healthelderly than SSE. ADH may represent a type of neu-in the elderly. Moreover, this trial was conducted toromodulation based on its superior therapeutic role

explore for adequate study design to investigate theover SSE, as evidenced in this trial. On the otherrole of ADH on elderly people. The difference of ther-hand, therapeutic mechanisms of ADH still have been

apeutic effect of ADH may not be much more thanunknown yet. However, the classical foot massage ef-

SSE. Therefore, more than 150 participants might befectively decreased insomnia and anxiety symptoms

required in each pathological condition to conduct thein the previous report via parasympathetic nerve acti-

next step considering the previous reports and power

have already been reported

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Ueno・Minagawa・Kurita et al.

calculation after this trial20）-22）. Second, subjective eval-interpret the obtain results of this trial, and indicateduation in the form of questionnaires were used toadequate study design as a further step about ADH

evaluate the impact of ADH. In our previous report,

research. Additional investigations that address the

bladder diaries, uroflowmetry, and residual urine vol-aforementioned limitations are warranted.

ume were adopted for objective assessment.1） The

ADH has several key advantages, including safety,

current trial was conducted among elderly people

portability, low cost, and efficacy as evidenced by our

averaging over 80 years old in nursing homes. The

trial. In contrast, the possible disadvantages of ADH

mean age of participants in this trial was very highare slight foot pain and restriction to individuals who

more than that expected in the designing of this trial.

can walk by themselves, with virtually no other de-That may also affect on the results of the results.

merits. Even with its limitations and a yet undefined

Nevertheless, obtaining objective findings in random-mechanism of action, ADH shows promise as usefulized trials are needed. In addition, considering ADH

health-promoting equipment.

as a handy physical therapy, wash-out period was

Ⅴ Conclusions

not set in this trial design. Moreover, we did not suppose a therapeutic role of SSE for each pathological

ADH displayed superior therapeutic efficacy for thecondition. As the results, prolonged effects of ADH

management of LUTS, insomnia, and HC over SSE.

should be considered, and SSE may have therapeutic

Physical foot stimulation may be the underlying mech-effects also. These findings are serious limitation toanism of ADH on general health improvement.

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