UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062094 |
|---|---|
| Receipt number | R000071047 |
| Scientific Title | A survey on nutritional management and rehabilitation in stroke patients and the association between nutritional management and clinical outcomes: a cohort study using a medical database |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/29 18:37:07 |
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Basic information
Public title
A survey on nutritional management and rehabilitation in stroke patients and the association between nutritional management and clinical outcomes
Acronym
Nutritional management, rehabilitation, and clinical outcomes in patients with stroke
Scientific Title
A survey on nutritional management and rehabilitation in stroke patients and the association between nutritional management and clinical outcomes: a cohort study using a medical database
Scientific Title:Acronym
Nutritional management, rehabilitation, and clinical outcomes in patients with stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Medicine in general | Neurology | Neurosurgery |
| Intensive care medicine | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate real-world nutritional management and rehabilitation practices in patients with stroke and to investigate the association between nutritional management and clinical outcomes using a claims database.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital mortality
Key secondary outcomes
1) Worsening of the modified Rankin Scale
2) Non-home discharge
3) Readmission
4) Worsening of the Barthel Index
5) Unchanged or worsened clinical outcome
6) Food Intake Level Scale <7
7) Length of hospital stay
8) Healthcare costs
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized for stroke in acute care hospitals
Key exclusion criteria
1) Missing body weight at admission
2) Body weight at admission <10 kg or >=300 kg
3) Discharge (alive or dead) within 7 days of admission
Target sample size
750000
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Yoshimura |
Organization
Kumamoto Rehabilitation Hospital
Division name
Center for Sarcopenia and Malnutrition Research
Zip code
869-1106
Address
760 Magate, Kikuyo Town, Kikuchi, Kumamoto, Japan
TEL
096-232-3111
hanley.belfus@gmail.com
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Horikoshi |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Medical Affairs Department
Zip code
101-0052
Address
5F, 1-1 Kanda Ogawamachi, Chiyoda-ku Tokyo, Japan
TEL
03-5577-4001
Homepage URL
Horikoshi.Yuri@otsuka.jp
Sponsor or person
Institute
Kumamoto Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto Rehabilitation Hospital Ethics Committee
Address
760 Magate, Kikuyo Town, Kikuchi, Kumamoto, Japan
Tel
096-232-3111
kumareha-hisyo@kumareha.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 | 30 | 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 | 29 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
A cohort study
Data source
A medical database by Medical Data Vision Co. Ltd. The database is based on the DPC data/medical claims database and covers approximately 32% of all DPC hospitals in Japan. All data is anonymized for personal information protection.
(1) Survey of acute-phase nutritional management
Nutritional management during the acute phase will be assessed using prescription and treatment data available in the database. The following items will be analyzed:
･Trends in routes of nutritional administration
･Trends in prescribed doses of parenteral nutrition
･Types of prescribed infusion preparations
･Distribution of prescribed doses of parenteral nutrition
(2) Association between supplemental parenteral nutrition / nutritional prescription doses and clinical outcomes
The associations of supplemental parenteral nutrition and nutritional prescription doses with clinical outcomes will be evaluated using multivariable logistic regression. Adjusted odds ratios and 95% confidence intervals will be estimated after adjustment for patient characteristics as confounders.
(3) Survey of nutritional management and rehabilitation in the convalescent ward
Nutritional management and rehabilitation in the convalescent ward will be assessed using prescription, treatment, and rehabilitation data available in the database. The following items will be analyzed:
･Trends in routes of nutritional administration
･Implementation status of nutritional interventions and rehabilitation
･Trends in Functional Independence Measure (FIM) scores
･Factors associated with FIM at discharge
Management information
Registered date
| 2026 | Year | 06 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071047
