UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056698 |
|---|---|
| Receipt number | R000064807 |
| Scientific Title | Muscle atrophy patterns of the lower limb versus the respiratory muscles in critically ill patients |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/01/13 09:59:23 |
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Basic information
Public title
Muscle atrophy patterns of the lower limb versus the respiratory muscles in critically ill patients
Acronym
Characteristic of muscle atrophy pattern for respiratory muscle
Scientific Title
Muscle atrophy patterns of the lower limb versus the respiratory muscles in critically ill patients
Scientific Title:Acronym
Characteristic of muscle atrophy pattern for respiratory muscle
Region
| Japan |
Condition
Condition
critically illness admitted at critical care medicine center
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify muscle atrophy pattern in respiratory and lower extremity muscles
Basic objectives2
Others
Basic objectives -Others
To investigate the factors affecting muscle atrophy of respiratory muscles
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in muscle thickness, cross-sectional area, and muscle brightness of the sternocleidomastoid and rectus femoris muscles by echo
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are at least 18 years of age and able to obtain consent or obtain written consent from next of kin
Key exclusion criteria
pregnancy, current incarceration, cognitive impairment, clinical instability as determined by healthcare professionals, COVID-19, poor pre-hospital functional status, and stroke or neuromuscular disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Sugiya |
Organization
Kindai University hospital
Division name
department of rehabilitation
Zip code
589-8511
Address
377-2, Oonohigashi, Osakasayama-city, Osaka, Japan
TEL
072-366-0221
ryuji.sugiya@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Sugiya |
Organization
Kindai university hospital
Division name
department of rehabilitation
Zip code
589-8511
Address
377-2, Oonohigashi, Osakasayama-city, Osaka, Japan
TEL
0723660221
Homepage URL
ryuji.sugiya@med.kindai.ac.jp
Sponsor or person
Institute
Kindai university hospital, department of rehabilitation, Ryuji Sugiya
Institute
Department
Personal name
Funding Source
Organization
none
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
Kinki University Ethics Committee
Address
377-2, Oonohigashi, Osakasayama-city, Osaka, Japan
Tel
0723660221
ryuji.sugiya@med.kindai.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 | 03 | Month | 01 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 01 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064807
