UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057638 |
|---|---|
| Receipt number | R000065858 |
| Scientific Title | A retrospective observational study of physical function items reflecting the index of ability to perform activities of daily living in patients admitted to a convalescent ward |
| Date of disclosure of the study information | 2025/04/17 |
| Last modified on | 2025/10/17 09:14:21 |
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Basic information
Public title
A retrospective observational study of physical function items reflecting the index of ability to perform activities of daily living in patients admitted to a convalescent ward
Acronym
A retrospective observational study of physical function items in patients admitted to a convalescent ward
Scientific Title
A retrospective observational study of physical function items reflecting the index of ability to perform activities of daily living in patients admitted to a convalescent ward
Scientific Title:Acronym
A retrospective observational study of physical function items in patients admitted to a convalescent ward
Region
| Japan |
Condition
Condition
Cases of hospitalization of recovering patients
Classification by specialty
| Pneumology | Neurology | Surgery in general |
| Orthopedics | Neurosurgery | Cardiovascular surgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sarcopenia (age-related loss of muscle mass) has been the focus of attention in the field of geriatrics. It has become clear that sarcopenia is a decline in muscle mass, muscle strength, and physical function, and is associated with social problems such as death, increased medical costs, and decreased ability to perform activities of daily living. In this study, muscle mass, muscle strength, and physical function items will be routinely measured to determine the prevalence of cases admitted to recovery wards. Muscle mass loss will be studied using the criteria for muscle mass loss proposed by the Asian Working Group on Sarcopenia (7.0 kg/m2 for men and 5.7 kg/m2 for women). The decline in muscle strength will be referenced to the measured grip strength (<28 kg in men and <18 kg in women). Decline in physical function will be evaluated comprehensively by measuring 10-meter walk, BBS (Berg Balance Scale), and 6-minute walk. The purpose of this study is to establish muscle mass for maintaining the ability to perform activities of daily living in patients admitted to the recovery ward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Independence in ability to perform activities of daily living (maintenance/improvement or worsening of independence in daily living), muscle mass
Key secondary outcomes
(1) Medical record information such as general inpatient daily living assessment, independence rate, survival rate, and application status of long-term care insurance for the subject
(2) Medical record information measured by rehabilitation staff
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Selection of subjects will not be made by the researcher, but will be a survey of all eligible facilities.
Key exclusion criteria
(1) When a case or a person related to the case contacts us in response to the opt-out form. (2) When the principal investigator determines that discontinuation of the research is appropriate.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | minami |
| Middle name | |
| Last name | sato |
Organization
International University of Health and Welfare, Odawara School of Health Sciences
Division name
Department of Physical Therapy
Zip code
250-8588
Address
1-2-25, Shiroyama, Odawara-shi, Kanagawa
TEL
0465-21-6720
msato@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | minami |
| Middle name | |
| Last name | sato |
Organization
International University of Health and Welfare, Odawara School of Health Sciences
Division name
Department of Physical Therapy
Zip code
250-8588
Address
1-2-25, Shiroyama, Odawara-shi, Kanagawa
TEL
0465-21-6720
Homepage URL
msato@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare, Odawara School of Health Sciences
Address
1-2-25, Shiroyama, Odawara-shi, Kanagawa
Tel
0465
msato@iuhw.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
| 2025 | Year | 04 | Month | 17 | 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
Currently measuring
Results date posted
| 2025 | Year | 05 | Month | 02 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, no special measurements will be conducted for the measurement, and the survey will focus on items that are recorded in the medical record. The items to be surveyed can be divided into (1) medical record information such as daily life assessments of general inpatients, facility users, and caregivers, and (2) medical record information for items measured by rehabilitation staff.
Management information
Registered date
| 2025 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065858
