UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057953 |
|---|---|
| Receipt number | R000066255 |
| Scientific Title | Impact of Malnutrition Diagnosed by GLIM Criteria on FIM-M Effectiveness in Elderly Patients with Fractures |
| Date of disclosure of the study information | 2025/05/24 |
| Last modified on | 2025/05/23 21:55:45 |
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Basic information
Public title
A study on how nutritional status affects rehabilitation outcomes in elderly patients with fractures
Acronym
Fracture, Nutrition, and Rehab
Scientific Title
Impact of Malnutrition Diagnosed by GLIM Criteria on FIM-M Effectiveness in Elderly Patients with Fractures
Scientific Title:Acronym
Association between GLIM and FIM-M
Region
| Japan |
Condition
Condition
Fractures in the elderly, Malnutrition
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of malnutrition diagnosed by the Global Leadership Initiative on Malnutrition (GLIM) criteria on the effectiveness of motor Functional Independence Measure (FIM-M) improvement in elderly patients with fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
FIM-M effectiveness (Improvement rate of motor items in the Functional Independence Measure)
Key secondary outcomes
Association with cognitive function (Hasegawa Dementia Scale-Revised; HDS-R)
Length of hospital stay
Days from onset to admission to the rehabilitation ward
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
| 999 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years or older with fractures admitted to the rehabilitation ward of our hospital between March 2024 and March 2025
Patients with a history of stroke, limb amputation, acute transfer, or death discharge were excluded
Patients without missing data
Key exclusion criteria
Patients under 65 years of age
Patients with a history of stroke
Patients with limb amputation
Patients transferred to acute care hospitals
Patients discharged due to death
Patients with missing data required for analysis
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | FUMIYA |
| Middle name | |
| Last name | MIZUNASHI |
Organization
Ama City Hospital
Division name
Rehabilitation Department
Zip code
490-1111
Address
1 Azeta Jimokuji, Ama City, Aichi 490-1111, Japan Approximately a 6-minute walk from Jimokuji Station on the Meitetsu Tsushima Line
TEL
052-444-0050
f05511033@gmail.com
Public contact
Name of contact person
| 1st name | FUMIYA |
| Middle name | |
| Last name | MIZUNASHI |
Organization
Ama City Hospital
Division name
Rehabilitation Department
Zip code
490-1111
Address
1 Azeta Jimokuji, Ama City, Aichi 490-1111, Japan Approximately a 6-minute walk from Jimokuji Statio
TEL
052-444-0050
Homepage URL
f05511033@gmail.com
Sponsor or person
Institute
Ama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Ama City Hospital
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
fumiya mizunashi
Address
1 Azeta Jimokuji, Ama City, Aichi 490-1111, Japan Approximately a 6-minute walk from Jimokuji Statio
Tel
052-444-0050
f05511033@gmail.com
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 | 05 | Month | 24 | 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
155
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
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective cohort study involving patients aged 65 years and older who were admitted to the convalescent rehabilitation ward of our hospital between March 2024 and March 2025. The study utilized existing clinical data recorded in electronic medical records. No interventions were performed, and the relationship between nutritional status and improvement in ADL (measured by FIM-M effectiveness) was examined.
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066255
