UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060503 |
|---|---|
| Receipt number | R000069175 |
| Scientific Title | Association between CT-derived psoas muscle area and volume indices on admission and clinical outcomes in elderly emergency admissions |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/28 19:49:35 |
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Basic information
Public title
Association between CT-derived psoas muscle area and volume indices on admission and clinical outcomes in elderly emergency admissions
Acronym
Psoas muscle Evaluation in Acute Care for the Elderly at National Center for Geriatrics and Gerontology (NCGG PEACE study)
Scientific Title
Association between CT-derived psoas muscle area and volume indices on admission and clinical outcomes in elderly emergency admissions
Scientific Title:Acronym
Psoas muscle Evaluation in Acute Care for the Elderly at National Center for Geriatrics and Gerontology (NCGG PEACE study)
Region
| Japan |
Condition
Condition
Sarcopenia in elderly emergency admissions
Classification by specialty
| Geriatrics | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to investigate whether psoas muscle volume index (PMVI), psoas muscle area index (PMA), and mean psoas muscle CT attenuation derived from admission CT scans can predict discharge outcomes (home discharge versus non-home discharge) in elderly patients admitted emergently.
The secondary objectives are: 1) To examine the association with length of hospital stay and in-hospital mortality,2) To compare the predictive ability of PMVI, PMA, and muscle quality (CT value),3) To explore clinically applicable cutoff values for these indices.
Basic objectives2
Others
Basic objectives -Others
This is a retrospective observational study without intervention. The basic objective of this study is to evaluate the association and predictive ability of CT-derived psoas muscle indices (PMVI, PMA, and mean CT attenuation) for discharge outcomes, and to assess their clinical usefulness as prognostic indicators.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Discharge outcome: Home discharge versus non-home discharge (transfer to another facility or in-hospital death)
Key secondary outcomes
1) Length of hospital stay 2) In-hospital mortality 3) Changes in activities of daily living (e.g., Barthel Index) 4) Amount of in-hospital rehabilitation intervention
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years or older who were emergently admitted to the Department of Geriatric Medicine between January 1,2023 and December 31,2023.
Key exclusion criteria
1) Patients without available admission non-contrast CT scans
2) Patients with concomitant malignant diseases
3) Patients transferred to another hospital for intensive care purposes
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Akatsu |
Organization
Hospital, National Center for Geriatrics and Gerontology
Division name
Center for Frailty and Locomotive Syndrome
Zip code
474-8511
Address
7-430 Moriokacho, Obu-shi, Aichi-ken 474-8511, Japan
TEL
0562-46-2311ext.6211
akatu@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Akatsu |
Organization
Hospital, National Center for Geriatrics and Gerontology
Division name
Center for Frailty and Locomotive Syndrome
Zip code
474-8511
Address
7-430 Moriokacho, Obu-shi, Aichi-ken 474-8511, Japan
TEL
0562-46-2311ext.6211
Homepage URL
akatu@ncgg.go.jp
Sponsor or person
Institute
Hospital, National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Hospital, National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya City University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hospital, National Center for Geriatrics and Gerontology
Address
7-430 Moriokacho, Obu-shi, Aichi-ken 474-8511, Japan
Tel
0562-46-2311ext.4683
yaday@ncgg.go.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
国立研究開発法人国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 01 | 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
| 2025 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
# Study design
This is a single-center retrospective observational study (non-interventional, non-invasive) using clinical data and admission CT images.
# Main exposure variables
1)Psoas muscle volume index (PMVI): the total bilateral psoas muscle volume divided by height squared
2)Psoas muscle area (PMA): the sum of bilateral psoas muscle cross-sectional areas at the L3 vertebral level
3)Mean psoas muscle CT attenuation value
# Statistical analysis
1)Logistic regression analyses will be performed to evaluate the association between the primary outcome and psoas muscle indices (PMVI/PMA/mean CT attenuation).
2)Receiver operating characteristic (ROC)curve analyses will be conducted to assess the predictive performance of each index, and optimal cutoff values will be determined using the Youden index.
3)In multivariable analyses, adjustments will be made for potential confounders, including age, sex, body mass index (BMI), comorbidities, laboratory data, activities of daily living (e.g., Barthel Index), amount of rehabilitation intervention, and frailty-related indices.
Management information
Registered date
| 2026 | Year | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069175
