UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058539 |
|---|---|
| Receipt number | R000066938 |
| Scientific Title | Clinical Factors Related to Body Composition in Acute Care Hospital Patients |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/22 00:48:59 |
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Basic information
Public title
Clinical Factors Related to Body Composition in Acute Care Hospital Patients
Acronym
Clinical Factors Related to Body Composition in Acute Care Hospital Patients
Scientific Title
Clinical Factors Related to Body Composition in Acute Care Hospital Patients
Scientific Title:Acronym
Clinical Factors Related to Body Composition in Acute Care Hospital Patients
Region
| Japan |
Condition
Condition
Patients over the age of 18 who are admitted to acute care hospitals
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Cardiology |
| Neurology | Orthopedics | Neurosurgery |
| Cardiovascular surgery | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate changes in body composition in patients admitted to acute care hospitals during their hospitalization.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to comprehensively examine the clinical factors associated with changes in body composition.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skeletal muscle mass or phase angle after hospitalization
Key secondary outcomes
Relationship among nutrition, activities of daily living, physical function, disease classification, and body composition.
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
Adult patients hospitalized for acute exacerbation of the following diseases or for surgery
Respiratory diseases or sepsis
Heart failure
Cardiovascular surgery
Pneumonia
Cerebral hemorrhage or cerebral infarction
Total hip or knee replacement surgery
Key exclusion criteria
Patients who cannot use Bioelectrical impedance analysis devices (e.g., those with pacemakers)
Patients have poor prognoses, and will not undergo active treatment.
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka International Medical & Science Center
Division name
Department of Rehabilitation Medicine
Zip code
543-8922
Address
2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
kohei.t68@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka International Medical & Science Center
Division name
Department of Rehabilitation Medicine
Zip code
543-8922
Address
2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
Homepage URL
kohei.t68@gmail.com
Sponsor or person
Institute
Osaka International Medical & Science Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Police Hospitals Ethics Committee
Address
2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan
Tel
06-6771-6051
tiken-info@oim.or.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
| 2025 | Year | 07 | Month | 22 | 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 | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing special to note
Management information
Registered date
| 2025 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066938
