UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061389 |
|---|---|
| Receipt number | R000069361 |
| Scientific Title | Verification of the effects of wearable devices on behavioral change and health outcomes in pre-frail and frail individuals: A feasibility study for a randomized controlled trial |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/27 15:23:06 |
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Basic information
Public title
A feasibility study on the effects of wearable devices on behavioral change and health outcomes in frail individuals
Acronym
A feasibility study on the effects of wearable devices in improving frailty
Scientific Title
Verification of the effects of wearable devices on behavioral change and health outcomes in pre-frail and frail individuals: A feasibility study for a randomized controlled trial
Scientific Title:Acronym
A feasibility study of the effects of wearable devices in improving pre-frailty and frailty
Region
| Japan |
Condition
Condition
prefrailty and frailty
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To be conducted a feasibility study to determine the feasibility of implementing the intervention and the effect of the intervention on outcome measures, prior to a randomized controlled trial of intervention using a wearable device and a behavior change application
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frailty based on Kihon Checklist
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For three months, participants wear insole- and wristband-type devices. Measurement data from the devices are displayed in a behavior change application. The contents displayed in the application change depending on the participant's behavioral stage and application usage.
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
| 65 | years-old | <= |
Age-upper limit
| 94 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Participants in the 2011 and 2017-2019 cohorts of the Otassha Study.
2. Individuals who meet the criteria for frailty (8 or more items) or pre-frailty (4-7 items) on the Kihon Checklist.
3. Individuals who own a smartphone.
4. Individuals who wish to participate in this study.
Key exclusion criteria
1. Individuals who are unable to participate in the pre- and post-assessments.
2. Individuals diagnosed with dementia or prescribed anti-dementia medication.
3. Individuals with impaired basic activities of daily living.
4. Individuals whose primary care physician has prohibited exercise (except light exercise).
5. Individuals with unstable or severe illnesses.
6. Individuals who have experienced angina pectoris, myocardial infarction, or cardiac surgery within the past three months, or individuals with terminal illnesses or receiving palliative care.
7. Individuals participating in specific rehabilitation programs.
8. Individuals currently participating in or planning to participate in other clinical trials during this study.
9. Individuals planning to participate in research using other mobile health apps during this study.
10. Individuals without a smartphone.
11. Individuals with difficulty communicating in Japanese.
12. Individuals deemed ineligible for participation by the principal investigator.
13. Individuals who are unable to provide consent to participate in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | P |
| Last name | Obuchi |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Human Care
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
obuchipc@tmig.or.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Kawai |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Human Care
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
hkawai@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-3241
hkawai@tmig.or.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 | 04 | Month | 27 | 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 | 02 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069361
