UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039955 |
|---|---|
| Receipt number | R000045544 |
| Scientific Title | Characteristics of patients who developed ICU-acquired weakness that difficult to improvement of physical function |
| Date of disclosure of the study information | 2020/03/27 |
| Last modified on | 2023/10/08 16:00:03 |
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Basic information
Public title
Characteristics of patients who developed ICU-acquired weakness that difficult to improvement of physical function
Acronym
Characteristics of patients who developed ICU-acquired weakness that difficult to improvement of physical function
Scientific Title
Characteristics of patients who developed ICU-acquired weakness that difficult to improvement of physical function
Scientific Title:Acronym
Characteristics of patients who developed ICU-acquired weakness that difficult to improvement of physical function
Region
| Japan |
Condition
Condition
ICU-acquired weakness
Classification by specialty
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of patients who difficult to improve physical function.
Basic objectives2
Others
Basic objectives -Others
Factors affecting physical function at discharge (MRC sum score <48)
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
MRC sum score(ICU admission, ICU discharge, hospital discharge)
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Closed ICU for more than 48 hours
2. MRC sum score < 48 (while in ICU)
Key exclusion criteria
1. Neuromuscular disorders in the medical history or as reason for admission
2. Orthopedic disease in the medical history or as reason for admission
3. After lung transplantation surgery
4. After artificial heart surgery
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Nagura |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
0958197258
nagura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nagura |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
0958197258
Homepage URL
nagura@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
Tel
0958197200
gaibushikin@ml.nagasaki-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
| 2020 | Year | 03 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 10 | Month | 09 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2020 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045544
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
