UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063028 |
|---|---|
| Receipt number | R000072152 |
| Scientific Title | Effects of Massage Chair Use on Blood Flow and Fatigue Reduction |
| Date of disclosure of the study information | 2026/09/23 |
| Last modified on | 2026/09/23 13:33:02 |
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Basic information
Public title
Acute Effects of Massage Chair Use on Peripheral Blood Flow in Postmenopausal Women
Acronym
Massage Chair Blood Flow Study
Scientific Title
Effects of Massage Chair Use on Blood Flow and Fatigue Reduction
Scientific Title:Acronym
Massage Chair Study
Region
| Japan |
Condition
Condition
Postmenopausal women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to quantitatively evaluate the acute effects of standardized whole-body massage chair stimulation on peripheral microcirculation in postmenopausal women using two-dimensional laser blood flow imaging. In particular, temporal changes in cutaneous microvascular blood flow at the volar forearm and anterior lower leg will be evaluated before the intervention and from immediately after the intervention to 30 min after its completion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Temporal changes in mean cutaneous blood flow (FLOW) within a predefined region of interest at the volar forearm. Measurements will be obtained using a two-dimensional laser blood flow imaging system (OZ-2STD, OMEGAZONE) at Pre, immediately after the intervention (Post0), and 5 (Post5), 10 (Post10), and 30 min (Post30) after the intervention. The primary analysis will evaluate the condition-by-time interaction between the massage chair and resting control conditions.
Key secondary outcomes
Temporal changes in mean cutaneous blood flow (FLOW) within a predefined region of interest at the anterior lower leg, measured at Pre, Post0, Post5, Post10, and Post30.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In Period 1, participants undergo a 20-min whole-body massage chair condition. A commercially available whole-body massage chair is used with a standardized automatic program including back-roller kneading, tapping, combined kneading and tapping, and airbag compression of the lower limbs, feet, waist, shoulders, and upper limbs. Stimulation intensity is set at a moderate level perceived by the participant as sufficiently stimulating but not excessively strong and is kept constant within each participant. The heater function is not used. After a washout period of at least 48 h, participants undergo a 20-min resting control condition in Period 2. During the control condition, participants remain seated in the same massage chair without activation of the roller or airbag functions.
Interventions/Control_2
In Period 1, participants undergo a 20-min resting control condition while seated in the same massage chair without activation of the roller or airbag functions. After a washout period of at least 48 h, participants undergo the 20-min whole-body massage chair condition in Period 2. The massage chair procedures and stimulation settings are identical to those described for Intervention 1.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Women aged 50-69 years.
2. Postmenopausal women who have experienced no menstruation for at least 12 months.
3. Individuals who understand the study procedures and are able to provide written informed consent.
Key exclusion criteria
1. Individuals who have been advised by a physician to restrict the use of massage devices.
2. Individuals with severe cardiovascular disease or severe arrhythmia.
3. Individuals with acute inflammation, wounds, or severe pain in the lower limbs or measurement sites.
4. Individuals judged by the principal investigator to be unable to safely undergo the intervention.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shiho |
| Middle name | |
| Last name | Kurosaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima 739-8524, Japan
TEL
082-424-6705
shihok@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Kurosaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima 739-8524, Japan
TEL
082-424-6705
Homepage URL
shihok@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
DAITO ELECTRIC MACHINE INDUSTRY CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Humanities and Social Sciences, Hiroshima University
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima 739-8524, Japan
Tel
082-424-6705
ed-ken-zai@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学（広島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was reviewed and approved by the Research Ethics Committee of the Graduate School of Humanities and Social Sciences, Hiroshima University. The ethics approval number is HR-ES-003711, with approval notification dated January 8, 2026. The research title approved by the ethics committee is "Effects of Massage Chair Use on Blood Flow and Fatigue Reduction." This study is funded by joint research funds based on a joint research contract between Hiroshima University and Daito Electric Machine Industry Co., Ltd. Daito Electric Machine Industry Co., Ltd. provides research funding only and is not involved in the study design, conduct, data collection or management, statistical analysis, interpretation of results, manuscript writing, or decisions regarding publication or submission.
Management information
Registered date
| 2026 | Year | 09 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072152
