UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026852 |
|---|---|
| Receipt number | R000030119 |
| Scientific Title | Intramuscular adipose and fibrous tissues of elderly inpatients |
| Date of disclosure of the study information | 2017/04/04 |
| Last modified on | 2024/10/09 09:45:03 |
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Basic information
Public title
Intramuscular adipose and fibrous tissues of elderly inpatients
Acronym
Intramuscular adipose and fibrous tissues of elderly inpatients
Scientific Title
Intramuscular adipose and fibrous tissues of elderly inpatients
Scientific Title:Acronym
Intramuscular adipose and fibrous tissues of elderly inpatients
Region
| Japan |
Condition
Condition
All diseases except progressive disease
Classification by specialty
| Medicine in general | Surgery in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine characteristics of intramuscular adipose and fibrous tissues in elderly inpatients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intramuscular adipose and fibrous tissues (quadriceps)
Key secondary outcomes
Muscle mass (quadriceps), muscle strength (quadriceps), degree of physical activity, activity of daily living, and destination (home or facility)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eelderly inpatients of all diseases
Key exclusion criteria
Progressive disease elderly inpatients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Akazawa |
Organization
Tokushima Bunri University
Division name
Faculty of health and welfare
Zip code
770-8514
Address
Boji, Yamashiro-cho, Tokushima-city, Tokushima
TEL
0886028531
akazawa@tks.bunri-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Akazawa |
Organization
Tokushima Bunri University
Division name
Faculty of health and welfare
Zip code
7708514
Address
Boji, Yamashiro-cho, Tokushima-city, Tokushima
TEL
0886028531
Homepage URL
akehioka@yahoo.co.jp
Sponsor or person
Institute
Tokushima Bunri University
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokushima Bunri University Institutional Review Board
Address
Hoji 180, Nishihama, Yamashiro-cho, Tokushima
Tel
0886028000
akazawa@tks.bunri-u.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
| 2017 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/jcsm.12713
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jcsm.12713
Number of participants that the trial has enrolled
404
Results
Quadriceps echo intensity was independently and significantly associated with the Barthel Index (BI) score at discharge. Quadriceps thickness was not independently and significantly associated with the BI score at discharge.
Results date posted
| 2024 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients aged <65 years
Participant flow
This study included older inpatients who were referred to the Department of Rehabilitation at Kasei Tamura Hospital.
Adverse events
N/A
Outcome measures
Quadriceps echo intensity
Quadriceps thickness
Barthel Index score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2017 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030119
