UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063538 |
|---|---|
| Receipt number | R000072717 |
| Scientific Title | Changes Over Time in Body Composition and Physical Function Among Outpatient Rehabilitation Patients and Their Association: A Retrospective Observational Study |
| Date of disclosure of the study information | 2026/11/05 |
| Last modified on | 2026/11/05 20:13:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Changes Over Time in Body Composition and Physical Function Among Outpatient Rehabilitation Patients and Their Association: A Retrospective Observational Study
Acronym
Changes Over Time in Body Composition and Physical Function Among Outpatient Rehabilitation Patients and Their Association: A Retrospective Observational Study
Scientific Title
Changes Over Time in Body Composition and Physical Function Among Outpatient Rehabilitation Patients and Their Association: A Retrospective Observational Study
Scientific Title:Acronym
Changes Over Time in Body Composition and Physical Function Among Outpatient Rehabilitation Patients and Their Association: A Retrospective Observational Study
Region
| Japan |
Condition
Condition
Individuals who utilized our hospital outpatient rehabilitation services between January 1, 2022, and October 1, 2026, and who underwent body composition measurements either during a medical examination or while receiving outpatient rehabilitation services.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is well known that in older adults, changes in body composition such as a decrease in muscle mass and changes in body water content occur due to aging, disease, and reduced physical activity, which in turn affect physical function and activities of daily living. Outpatient rehabilitation programs provide ongoing rehabilitation aimed at maintaining and improving client physical and functional abilities therefore, monitoring changes in physical condition over time including body composition is crucial for evaluating treatment effectiveness and determining future support strategies. In recent years, body composition analyzers using bioelectrical impedance analysis have been utilized in clinical settings, making it possible to assess skeletal muscle mass, body fat mass, and body water status relatively easily.
However, it remains unclear how changes in body composition over time correlate with changes in physical function among outpatients receiving rehabilitation services. Therefore, this study conducted a retrospective review of medical records of outpatients receiving rehabilitation services to examine the changes over time in body composition measurements and physical function assessments at baseline, 3 months, and 6 months, as well as the relationship between the two.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic Information
Physical Function Assessment Records for Outpatient Rehabilitation
Measurement Results from a Body Composition Analyzer
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who utilized our hospital outpatient rehabilitation services between January 1, 2022, and October 1, 2026, and who underwent body composition measurements either during a medical examination or while receiving outpatient rehabilitation services.
Key exclusion criteria
Individuals for whom it was difficult to conduct physical function assessments during outpatient rehabilitation, and those for whom it was difficult to take body composition measurements
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Chibana |
Organization
Kawaguchi Neurosurgery and Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
202-25-9, Kariyono-cho, Hirakata City, Osaka
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Kawaguchi Neurosurgery and Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
202-25-9, Kariyono-cho, Hirakata City, Osaka
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery and Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Kawaguchi Neurosurgery and Rehabilitation Clinic
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
Kawaguchi Neurosurgery and Rehabilitation Clinic
Address
202-25-9, Kariyono-cho, Hirakata City, Osaka
Tel
0728351010
kawaguchi.ns.reha@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
| 2026 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will collect data from medical records regarding the basic information of individuals who have used our outpatient rehabilitation services, records of physical function assessments conducted during outpatient rehabilitation, and body composition measurements taken at the start of outpatient rehabilitation and at the 3 month and 6 month marks.
Management information
Registered date
| 2026 | Year | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072717
