UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061298 |
|---|---|
| Receipt number | R000070133 |
| Scientific Title | A prospective observational study of participants in musculoskeletal health check at the Medical Fitness & Neuromodulation Center |
| Date of disclosure of the study information | 2026/04/17 |
| Last modified on | 2026/04/17 22:00:48 |
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Basic information
Public title
A prospective observational study of participants in musculoskeletal health check at the Medical Fitness & Neuromodulation Center
Acronym
A prospective observational study of participants in musculoskeletal health check
Scientific Title
A prospective observational study of participants in musculoskeletal health check at the Medical Fitness & Neuromodulation Center
Scientific Title:Acronym
A prospective observational study of participants in musculoskeletal health check
Region
| Japan |
Condition
Condition
Participants in musculoskeletal health check
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the characteristics of impaired motor function and the factors influencing them among participants in self-pay musculoskeletal health checks at Keio University Hospital Medical Fitness and Neuromodulation Center
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone density, body composition, locomotive syndrome tests (Locomo 25, 2-Step Test, Stand-Up Test), grip strength, lower limb muscle strength, walking speed, Timed Up and Go (TUG) test, single-leg stance, Japanese Cardiovascular Health Study (J-CHS), health-related quality of life (EQ-5D-5L)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 18 or older at the time consent is obtained
Individuals who can provide verbal consent to participate in this study
Key exclusion criteria
Individuals with significant lower limb dysfunction and walking difficulties (who have difficulty standing without a handrail or walking without a walking aid)
Individuals deemed unsuitable for participation in this study by the principal investigator or a co-investigator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Nagura |
Organization
Keio University School of Medicine
Division name
Department of Clinical Biomechanics
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
0333531211
keiolocomocheckup@gmail.com
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Sawada |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
0333531211
Homepage URL
keiolocomocheckup@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Other
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
Institutional Review Board of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
0353633503
med-rinri-jimu@adst.keio.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 | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study, and in principle, participation in the study will not result in any additional tests or treatments compared to routine medical care. There are no anticipated specific benefits for study participants resulting from their participation, including financial benefits. However, this study has the potential to lead to the development of new intervention strategies for the prevention of locomotive syndrome and is expected to contribute to extending the healthy life expectancy of the population; therefore, it is considered to have significant social contribution.
Management information
Registered date
| 2026 | Year | 04 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070133
