UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056443 |
|---|---|
| Receipt number | R000064503 |
| Scientific Title | Relationship between erector spinae muscle cross-sectional area and ICU-acquired weakness in patients with admission to the ICU |
| Date of disclosure of the study information | 2024/12/13 |
| Last modified on | 2025/11/13 19:19:29 |
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Basic information
Public title
Relationship between erector spinae muscle cross-sectional area and ICU-acquired weakness in patients with admission to the ICU
Acronym
Relationship between erector spinae muscle cross-sectional area and ICU-acquired weakness in patients with admission to the ICU
Scientific Title
Relationship between erector spinae muscle cross-sectional area and ICU-acquired weakness in patients with admission to the ICU
Scientific Title:Acronym
Relationship between erector spinae muscle cross-sectional area and ICU-acquired weakness in patients with admission to the ICU
Region
| Japan |
Condition
Condition
Intensive Care Unit-Acquired Weakness (ICU-AW)
Classification by specialty
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between erector spinae muscle cross-sectional area in admission to the ICU, and ICU-AW, muscle strength and ADL
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ICU-acquired weakness
skeletal muscle strength
Basic mobility
Activities of daily living
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with admission to the ICU
Key exclusion criteria
Patients with non-independent ADL before to ICU admission
Patients with central disease such as stroke or spinal cord injury, or musculoskeletal disease such as limb loss
Patients who have not undergo CT scan at admission to the ICU
Patients who difficulty assessing muscle strength due to treatment devices
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Uenishi |
Organization
Kio University
Division name
Division of Health Science, Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL
0745-54-1601
f4948277@kio.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Uenishi |
Organization
Kio University
Division name
Division of Health Science, Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL
0745-54-1601
Homepage URL
f4948277@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee of Kio University
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
Tel
0745-54-1601
f4948277@kio.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
国立病院機構 大阪医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 13 | 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
| 2024 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Measure the cross-sectional area of the erector spinae muscles in patients admitted to the ICU, investigate the onset of ICU-AW, skeletal muscle strength, and basic mobility to examine the relationship
Management information
Registered date
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064503
