UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049537 |
|---|---|
| Receipt number | R000056405 |
| Scientific Title | Validity of muscle mass assessment using ultrasound in patient with lower leg edema |
| Date of disclosure of the study information | 2022/11/17 |
| Last modified on | 2024/01/08 15:56:19 |
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Basic information
Public title
Validity of muscle mass assessment using ultrasound in patient with lower leg edema
Acronym
Validity of muscle mass assessment using ultrasound in patient with lower leg edema
Scientific Title
Validity of muscle mass assessment using ultrasound in patient with lower leg edema
Scientific Title:Acronym
Validity of muscle mass assessment using ultrasound in patient with lower leg edema
Region
| Japan |
Condition
Condition
Gastroenterology
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is Validity of muscle mass assessment using ultrasound in patient with lower leg edema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lumbar 3 Cross-Sectional area by abdomen CT scan
Muscle Mass using bioelectrical impedance analysis
Muscle thickness and cross sectional area using ultrasound
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Able to hold standig position
Key exclusion criteria
The patient have orthopedic and neurological diseases related muscle weakness
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Sawai |
Organization
Shizuoka general hospital
Division name
Department of physical therapy
Zip code
4200881
Address
27-1,4cho-me,Kitaando,aoiku,shizuoka,shizuoka
TEL
0542476111
uruku.phantomhive05@gmail.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Sawai |
Organization
shizuoka general hospital
Division name
Department of physical therapy
Zip code
4200881
Address
27-1,4cho-me,Kitaando,aoiku,shizuoka,shizuoka
TEL
0542476111
Homepage URL
uruku.phantomhive05@gmail.com
Sponsor or person
Institute
Shizuoka general hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka general hospital
Address
27-1,4cho-me,Kitaando,aoiku,shizuoka,shizuoka
Tel
0542476111
uruku.phantomhive05@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
| 2022 | Year | 11 | 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
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
Terminated
Date of protocol fixation
| 2022 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056405
