UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062724 |
|---|---|
| Receipt number | R000071425 |
| Scientific Title | Association Between Nutritional Status According to the GLIM Criteria and Longitudinal Changes in Functional Independence Measure (FIM) Scores in Patients Admitted to a Convalescent Rehabilitation Ward |
| Date of disclosure of the study information | 2026/08/28 |
| Last modified on | 2026/08/28 14:22:57 |
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Basic information
Public title
Association Between Nutritional Status According to the GLIM Criteria and Longitudinal Changes in Functional Independence Measure (FIM) Scores in Patients Admitted to a Convalescent Rehabilitation Ward
Acronym
GLIM-FIM Rehabilitation Study
Scientific Title
Association Between Nutritional Status According to the GLIM Criteria and Longitudinal Changes in Functional Independence Measure (FIM) Scores in Patients Admitted to a Convalescent Rehabilitation Ward
Scientific Title:Acronym
GLIM-FIM Rehabilitation Study
Region
| Japan |
Condition
Condition
Patients Aged 65 Years and Older Admitted to a Convalescent Rehabilitation Ward
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between nutritional status based on the Global Leadership Initiative on Malnutrition (GLIM) criteria at admission and longitudinal changes in the Functional Independence Measure (FIM), as well as swallowing function, in patients aged 65 years and older admitted to a convalescent rehabilitation ward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Longitudinal changes in the Functional Independence Measure (FIM) scores
Key secondary outcomes
Swallowing function
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 and older admitted to a convalescent rehabilitation ward who have provided written informed consent.
Key exclusion criteria
Patients for whom the required assessment data (e.g., Functional Independence Measure [FIM] or nutritional assessment) cannot be obtained.
Patients judged by the principal investigator or sub-investigators to be unsuitable for participation in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, Nara-shi, Nara, Japan
TEL
0742-41-4742
sa-abe@tezukayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, Nara-shi, Nara, Japan
TEL
0742-41-4742
Homepage URL
sa-abe@tezukayama-u.ac.jp
Sponsor or person
Institute
Tezukayama University
Institute
Department
Personal name
Funding Source
Organization
Tezukayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tezukayama University
Address
Gakuenminami 3-1-3, Nara-shi, Nara, Japan
Tel
0742-41-4742
sa-abe@tezukayama-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
| 2026 | Year | 08 | Month | 28 | 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 | 04 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study. The study will investigate the association between nutritional status based on the Global Leadership Initiative on Malnutrition (GLIM) criteria at admission and longitudinal changes in the Functional Independence Measure (FIM), as well as swallowing function, in patients aged 65 years and older admitted to a convalescent rehabilitation ward.
Management information
Registered date
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071425
