UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048072 |
|---|---|
| Receipt number | R000054787 |
| Scientific Title | A research on core elements of physical actitivies, leading to prevention of long-term care, using IoT. |
| Date of disclosure of the study information | 2022/09/09 |
| Last modified on | 2026/02/24 12:27:37 |
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Basic information
Public title
A research on core elements of physical actitivies, leading to prevention of long-term care, using IoT.
Acronym
A research on core elements of physical actitivies, leading to prevention of long-term care, using IoT.
Scientific Title
A research on core elements of physical actitivies, leading to prevention of long-term care, using IoT.
Scientific Title:Acronym
A research on core elements of physical actitivies, leading to prevention of long-term care, using IoT.
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
i) Exploratory research on core elements of physical actitivies in IoT, leading to prevention of locomotive syndrome and frailty, ii) a proposal of core elements for this purpose in PHR (personal health records), iii) examination of implementation of the data infrastructure of physical actitivies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The locomotive syndrome risk test, frailty evaluation score
Key secondary outcomes
body composition, physical function test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
execise for 2 months
Interventions/Control_2
education on physical activities
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
worse than stage 1 of the locomotive sydrome
Key exclusion criteria
Those who were hospitalized within one month
Those who have a history of lower limb or spine surgery within 3 months
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ohe |
| Middle name | |
| Last name | Kazuhiko |
Organization
The University of Tokyo Hospital
Division name
Planning and Information Management Department
Zip code
113-8655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
+81338155411
ohe-office@adm.h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yamada |
| Middle name | |
| Last name | Keiko |
Organization
The University of Tokyo Hospital
Division name
Department of rehabilitation
Zip code
113-8655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
+81338155411
Homepage URL
yamadak@adm.h.u-tokyo.ac.jp
Sponsor or person
Institute
The university of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
TIS
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
The University of Tokyo
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
Tel
+81-3-5841-0818
ethics@m.u-tokyo.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
| 2022 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000054787
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/41678940/
Number of participants that the trial has enrolled
83
Results
Accelerometer-based metrics obtained from both the upper and lower trunk reflect physical function and may serve as indicators of early gait impairment, as well as for future interventional studies.
Results date posted
| 2026 | Year | 02 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 01 | Month | 29 | Day |
Baseline Characteristics
The participants were screened by questionnaire about their mobility and were recruited if they experienced uncertainty when standing on one leg from a seated position or perceived their usual gait speed as slower than others.
Participant flow
exercise intervenion for 2 months
Adverse events
none
Outcome measures
locomotive syndrome risk test, Accelerometer-based metrics obtained from both the upper and lower trunk TUG
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 16 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054787
