UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062120 |
|---|---|
| Receipt number | R000071083 |
| Scientific Title | A Prospective Observational Study on the Effects of Continuous Use of the Relive Innerwear (Top and Leggings Set) on Physical Function, Autonomic Nervous Function, Peripheral Circulation, Sleep, Mood, Physical Activity, and Quality of Life in Older Adults |
| Date of disclosure of the study information | 2026/07/03 |
| Last modified on | 2026/07/02 14:02:41 |
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Basic information
Public title
Prospective Observational Study of Changes in Physical Function, Autonomic Nervous Function, and Quality of Life Associated with Wearing the Relive Innerwear (Top and Leggings Set)
Acronym
EVI Study
Scientific Title
A Prospective Observational Study on the Effects of Continuous Use of the Relive Innerwear (Top and Leggings Set) on Physical Function, Autonomic Nervous Function, Peripheral Circulation, Sleep, Mood, Physical Activity, and Quality of Life in Older Adults
Scientific Title:Acronym
EVI Study
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this prospective observational study is to evaluate longitudinal changes in physical function, autonomic nervous system function, peripheral circulation, sleep, mood status, subjective health status, and health-related quality of life (QOL) in adults aged 60 years or older who routinely wear the Relive Inner Shirt and Leggings Set. The study will also exploratorily assess wearing adherence, safety, and feasibility to obtain preliminary data regarding the potential of this non-pharmacological approach for supporting health maintenance and quality of life in older adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in handgrip strength measured using the grip dynamometer attached to the InBody BWA2.0S from baseline to 3 months.
Key secondary outcomes
Physical function (range of motion, skeletal muscle mass, body fat mass, body water, extracellular water ratio, and segmental body water)
Autonomic nervous system function (heart rate, respiratory rate, HF, and LF)
Peripheral circulation (blood flow, blood flow velocity, oxygen saturation, hemoglobin concentration, and capillary refill time)
Skin and tongue image analysis (skin texture, melanin index, hemoglobin index, and skin glossiness)
Frailty status (FR-IC Index)
Mood status (Profile of Mood States, POMS)
Health-related quality of life (SF-36)
Fatigue (Brief Fatigue Inventory, BFI)
Sleep quality (Pittsburgh Sleep Quality Index Japanese version, PSQI-J)
Wearing adherence (continuation over 6 months and wearing at least 5 days per week at 1, 3, and 6 months)
Incidence of adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Male or female participants aged 60 years or older.
2.Participants who subjectively experience fatigue, easy fatigability, or decreased muscle strength in daily life.
3.Participants who are able and willing to wear the Relive Inner Shirt and Leggings Set continuously during the study period in their daily lives.
Key exclusion criteria
1.Participants with severe cardiovascular, respiratory, neurological, psychiatric, or malignant diseases, or any other serious underlying medical condition, who are considered unsuitable for participation by the principal investigator or sub-investigator.
2.Participants with skin diseases, rash, pruritus, contact dermatitis, allergy to clothing materials, or other conditions that may worsen with wearing the Relive Inner Shirt and Leggings Set.
3.Participants with cognitive impairment, communication difficulties, or visual or hearing impairment that would interfere with understanding the study, providing informed consent, completing questionnaires, or undergoing study assessments.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Ogawa |
Organization
Hiroshima University
Division name
Hospital Kampo Medical Center
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-1921
okeiko22@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | Inoue |
| Last name | Chiyokori |
Organization
Hiroshima University Hospital
Division name
Kampo Medical Center
Zip code
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
08225271921
Homepage URL
chiyoman@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Relive Co., Ltd. (Japan)
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
Hiroshima University Hospital Ethics Committee
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
0822575555
iryo-sinsa@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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 03 | 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 | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071083
