UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057054 |
|---|---|
| Receipt number | R000065211 |
| Scientific Title | Identification of Health-Related Risk Factors Associated with Walking Ability in Older Adults with Sarcopenia |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/08/19 09:44:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Identification of Health-Related Risk Factors Associated with Walking Ability in Older Adults with Sarcopenia
Acronym
Identification of Risk Factors in Older Adults with Sarcopenia
Scientific Title
Identification of Health-Related Risk Factors Associated with Walking Ability in Older Adults with Sarcopenia
Scientific Title:Acronym
Identification of Risk Factors in Older Adults with Sarcopenia
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to characterize gait according to the severity of sarcopenia and to identify health-related risk factors associated with this walking ability.
Basic objectives2
Others
Basic objectives -Others
To achieve the aforementioned research objectives, the plan is to identify the following
(i) To clarify the characteristics of gait parameters according to the severity of sarcopenia (no sarcopenia - sarcopenia - severe sarcopenia).
(ii) To extract health-related factors related to the severity of sarcopenia (daily steps, nighttime sleep duration, basic checklist, etc.) using multivariate analysis (multinomial logistic regression analysis, etc.).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sarcopenia severity classification according to AWGS (Asian Working Group for Sarcopenia) diagnostic criteria AWGS2019
Key secondary outcomes
Walking ability, health-related indicators
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who will use the services between the date of approval by the head of the research institution and March 31, 2027
(2) Subjects who are able to obtain free and voluntary consent for participation in research in writing from the subject
(3) Subjects who are 65 years of age or older at the time of obtaining consent.
Key exclusion criteria
(1) Persons with severe motor unit dysfunction and difficulty in performing the tests for sarcopenia severity classification.
(2) Those with strong psychiatric symptoms and significant cognitive dysfunction
Target sample size
184
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Kume |
Organization
Akita university
Division name
Graduate School of Medicine
Zip code
010-8543
Address
Hondo1-1-1, Akita city
TEL
0188846556
kume.yuu@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kume |
Organization
Akita university
Division name
Health Sciences
Zip code
010-8543
Address
Hondo 1-1-1, Akita city
TEL
018846556
Homepage URL
kume.yuu@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Yu Kume
Funding Source
Organization
Akita University
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
Akita University
Address
Hondo 1-1-1, Akita city
Tel
0188846556
kume.yuu@hs.akita-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
| 2025 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observational study will assess users of health promotion facilities or day care services according to the AWGS (Asian Working Group for Sarcopenia) diagnostic criteria AWGS2019 reported in 2019 to classify the severity of sarcopenia.AWGS 2019 recommends that an algorithm for (1) case finding (leg circumference, SARC-F questionnaire for screening sarcopenia), (2) assessment (grip strength, five chair rise test), and (3) diagnosis (grip strength, five chair rise test, skeletal muscle mass) of sarcopenia be used, depending on local healthcare settings. The severity of sarcopenia is classified according to AWGS2019.
Subsequently, a 10-meter walk test will be performed with the ORPHE ANALYTICS MEDICAL, a sensor device manufactured by ORPHE, attached to the shoe for objective analysis of walking ability. Other data on health status including age, gender, falls, daily steps, nighttime sleeping habits, basic checklist, etc. will be collected.
As a statistical study, multivariate analysis according to the severity of sarcopenia will be performed to characterize gait and extract daily health-related factors associated with gait parameters.
Management information
Registered date
| 2025 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065211
