UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040135 |
|---|---|
| Receipt number | R000045764 |
| Scientific Title | Association of physical symptoms during hospitalization and walking ability at discharge in critically ill patients |
| Date of disclosure of the study information | 2020/04/12 |
| Last modified on | 2020/04/12 19:40:22 |
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Basic information
Public title
Association of physical symptoms during hospitalization after severe illness with walking ability at discharge
Acronym
Association of physical symptoms during hospitalization after severe illness with walking ability at discharge
Scientific Title
Association of physical symptoms during hospitalization and walking ability at discharge in critically ill patients
Scientific Title:Acronym
Association of physical symptoms during hospitalization and walking ability at discharge in critically ill patients
Region
| Japan |
Condition
Condition
critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether physical symptoms affect walking ability during hospitalization and QOL at discharge in critically ill patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors related to walking ability
Key secondary outcomes
Factors related to QOL at discharge
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
Patients who entered ICU dedicated by the intensive care physician
Key exclusion criteria
ICU stay less than 72 hours, history and complications of central nervous system disease, trauma, limb amputation patient, post-organ transplantation patient, assisted heart transplant patient, non-independent walking patient before ICU admission, purpose of study Patients who do not understand and have difficulty communicating
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | Watanabe |
Organization
Nagasaki University Hospital
Division name
Rehabilitation department
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
0958197258
tsu-watanabe@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Watanabe |
Organization
Nagasaki University Hospital
Division name
Rehabilitation department
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
0958197258
Homepage URL
tsu-watanabe@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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 Rehabilitation Department
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
0958197258
tsu-watanabe@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 | 04 | Month | 12 | 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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observation period is from ICU admission to discharge.
Management information
Registered date
| 2020 | Year | 04 | Month | 12 | Day |
Last modified on
| 2020 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045764
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| Registered date | File name |
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