UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061565 |
|---|---|
| Receipt number | R000070430 |
| Scientific Title | Standardization of Ultrasound Muscle Mass Assessment Led by Physical Therapists to Promote Muscle Health and Prevent Sarcopenia: Establishment of Japanese Reference Values for the STAR Muscle Mass Index Aligned with AWGS2025 |
| Date of disclosure of the study information | 2026/06/10 |
| Last modified on | 2026/05/14 12:05:10 |
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Basic information
Public title
Standardization of Ultrasound Muscle Mass Assessment Led by Physical Therapists to Promote Muscle Health and Prevent Sarcopenia: Establishment of Japanese Reference Values for the STAR Muscle Mass Index Aligned with AWGS2025
Acronym
Establishment of Japanese Reference Values for STAR to Promote Muscle Health and Prevent Sarcopenia
Scientific Title
Standardization of Ultrasound Muscle Mass Assessment Led by Physical Therapists to Promote Muscle Health and Prevent Sarcopenia: Establishment of Japanese Reference Values for the STAR Muscle Mass Index Aligned with AWGS2025
Scientific Title:Acronym
Establishment of Japanese Reference Values for STAR to Promote Muscle Health and Prevent Sarcopenia
Region
| Japan |
Condition
Condition
Community-dwelling individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish Japanese reference values for STAR, develop an ultrasound-based muscle mass assessment aligned with the Muscle Health Promotion concept of AWGS2025, and build physiotherapy evidence contributing to healthy life expectancy extension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sonographic Thigh Adjustment Ratio (STAR)
Key secondary outcomes
Appendicular skeletal muscle mass index (ASMI), Grip strength, Knee extension strength, Muscle specific strength, Short physical performance battery, Age, Sex, Body mass index, Exercise habits, Lifestyle habits, Intrinsic capacity
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals who consented, including participants at local health check events, university students from the affiliated university, and staff from the affiliated facility
Key exclusion criteria
Individuals with diseases affecting muscle mass and strength, such as neuromuscular disorders
Individuals with implanted electrode devices such as pacemakers
Individuals unable to undergo physical fitness testing due to illness or poor health
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Ikemoto |
Organization
Kio University Graduate School
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara prefecture
TEL
09059614994
taiki.ikemoto.1202@gmail.com
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Ikemoto |
Organization
Kio University Graduate School
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara prefecture
TEL
09059614994
Homepage URL
taiki.ikemoto.1202@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Physical Therapy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University ethics committee
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara prefecture
Tel
0745541602
soumu@kio.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 | 06 | Month | 10 | 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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 10 | 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
None
Management information
Registered date
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070430
