UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061393 |
|---|---|
| Receipt number | R000070236 |
| Scientific Title | Association Between Post-Discharge Nutritional Intake and Readmission Risk in Elderly Women with Proximal Femoral Fractures: A Single-Center Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/27 18:50:19 |
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Basic information
Public title
Relationship Between Diet After Discharge and Risk of Readmission in Elderly Women with Proximal Femoral Fractures
Acronym
Diet After Discharge and Risk of Readmission (PNIRR)
Scientific Title
Association Between Post-Discharge Nutritional Intake and Readmission Risk in Elderly Women with Proximal Femoral Fractures: A Single-Center Retrospective Cohort Study
Scientific Title:Acronym
Post-discharge Nutritional Intake and Readmission Risk (PNIRR)
Region
| Japan |
Condition
Condition
Proximal femoral fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the association between post-discharge nutritional intake and the risk of readmission among elderly women with proximal femoral fractures who were discharged from a rehabilitation hospital. In particular, this study focuses on not only energy and protein intake but also micronutrient intake, including vitamin D, vitamin C, and zinc, as well as food group consumption, and compares these factors between the readmission and non-readmission groups.
Basic objectives2
Others
Basic objectives -Others
This study is a retrospective observational study aimed at investigating the association between post-discharge nutritional intake and the risk of readmission, and to explore prognostic factors without any intervention.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of readmission within two years after discharge, defined as hospitalization due to fracture or fracture-related complications. Assessments will be conducted at 6, 12, and 18 months after discharge, and readmission status will be confirmed during the follow-up period up to 24 months.
Key secondary outcomes
Changes and between-group comparisons at 6, 12, 18, and 24 months after discharge in the following variables:
(1) Nutrient intake (energy, protein, fat, carbohydrates, calcium, magnesium, zinc, vitamin D, vitamin K, vitamin C, and salt equivalent)
(2) Body composition (muscle mass, skeletal muscle mass, body fat percentage, and skeletal muscle index)
(3) Biochemical parameters (e.g., serum albumin)
(4) Food group intake (grains, seafood, meat, vegetables, fruits, etc.)
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
Female
Key inclusion criteria
Elderly female patients with proximal femoral fractures who were discharged from a convalescent rehabilitation hospital and for whom data on post-discharge nutritional intake and readmission are available.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
(1) Missing data on post-discharge nutritional intake
(2) Inability to confirm readmission status
(3) Death during the follow-up period
(4) Presence of severe comorbidities (e.g., malignant tumors, severe heart failure, or severe renal failure) that may substantially affect nutritional intake or the risk of readmission
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Arai |
Organization
Laboratory of Clinical Nutrition and Management, University of Shizuoka
Division name
Laboratory of Clinical Nutrition and Management, Graduate School of Integrated Pharmaceutical and Nutritional Sciences, University of Shizuoka
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka Japan
TEL
81-54-264-5511
arai@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Baba |
Organization
The University of Shizuoka
Division name
Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka Japan
TEL
09056372002
Homepage URL
m.baba2828@gmail.com
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Masami Baba
Funding Source
Organization
No external funding (self-funded study)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Zenshokai Medical Corporation
Address
1-11 Matsuike-cho, Minami-ku, Nagoya, Aichi, Japan
Tel
0528119101
info@zenjokai.co.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
善常会リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
132
Results
A total of 132 patients with proximal femoral fractures discharged from a rehabilitation hospital were analyzed. Lower post-discharge energy and protein intake were associated with a higher risk of readmission. Differences were also observed in micronutrient intake, including vitamin D, vitamin C, and zinc, as well as food group consumption between groups.
Results date posted
| 2026 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included elderly women with proximal femoral fractures discharged from a rehabilitation ward. Baseline characteristics included age, body mass index, nutritional status (e.g., serum albumin), physical function, and dietary intake. Participants were classified into readmission and non-readmission groups based on readmission status during the follow-up period, and baseline characteristics were compared between the groups.
Participant flow
Elderly women with proximal femoral fractures discharged from a rehabilitation ward were considered for inclusion. Patients with missing data or loss to follow-up were excluded, and the remaining participants were included in the final analysis. Participants were classified into readmission and non-readmission groups based on readmission status during the follow-up period. All participants were followed for up to 24 months to confirm readmission status.
Adverse events
This study was a retrospective observational study without any intervention; therefore, no adverse events related to the study were observed.
Outcome measures
The primary outcome was the incidence of readmission within 2 years after discharge, defined as hospitalization due to fracture or fracture-related complications. Secondary outcomes included changes and between-group comparisons at 6, 12, 18, and 24 months after discharge in nutritional intake (energy, protein, fat, carbohydrates, calcium, magnesium, zinc, vitamin D, vitamin K, vitamin C, and salt equivalent), body composition (skeletal muscle mass, bone mineral density, body fat percentage, and skeletal muscle index), blood biochemical parameters (including serum albumin), and food group intake (grains, fish and shellfish, meat, vegetables, and fruits).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective observational study utilizes existing clinical records and nutritional assessment data without any intervention. The objective is to examine the association between post-discharge nutritional intake and the risk of readmission among patients with proximal femoral fractures.
Management information
Registered date
| 2026 | Year | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070236
