UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042433 |
|---|---|
| Receipt number | R000048441 |
| Scientific Title | Low muscle mass at admission predicts poor ADL in acute ischemic stroke. |
| Date of disclosure of the study information | 2020/11/13 |
| Last modified on | 2020/11/12 20:29:40 |
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Basic information
Public title
Low muscle mass at admission predicts poor ADL in acute ischemic stroke.
Acronym
Low muscle mass at admission predicts poor ADL in acute ischemic stroke.
Scientific Title
Low muscle mass at admission predicts poor ADL in acute ischemic stroke.
Scientific Title:Acronym
Low muscle mass at admission predicts poor ADL in acute ischemic stroke.
Region
| Japan |
Condition
Condition
ischemic stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to clarify whether low muscle mass is a prognosis factor for ADL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FIM at the discharge of acute hospital
Key secondary outcomes
mRS at the discharge of acute hospital
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
(1) dependent walking at admission ; (2) Measure skeletal muscle mass within 5 days of admission.
Key exclusion criteria
(1) pre-stroke functional limitation (mRS score >3) ; (2) hemorrhagic infraction ; (3) other symptoms encumber walking (e.g., lower-extremity amputation, lower limb fracture, and others) ; (4) dead in the hospital ; (5) more than 3 days of intubation or 5 days of bed rest due to losing skeletal muscle mass after admission.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Kimura |
Organization
Kobe city medical center general hospital
Division name
Rehabilitation
Zip code
650-0047
Address
2-1-1 Minatojimaminamimachi Chuo-ku, Kobe-shi, Hyogo-ken, Japan
TEL
08074172035
hpm19004@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kimura |
Organization
Kobe city medical center general hospital
Division name
Rehabilitation
Zip code
650-0047
Address
2-1-1 Minatojimaminamimachi Chuo-ku, Kobe-shi, Hyogo-ken, Japan
TEL
08074172035
Homepage URL
hpm19004@nuhw.ac.jp
Sponsor or person
Institute
Kobe city medical center general hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Health and Welfare, Niigata University of Health and Welfare
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe city medical center general hospital, research ethics committee
Address
2-1-1 Minatojimaminamimachi Chuo-ku, Kobe-shi, Hyogo-ken, Japan
Tel
078-302-5176
rinken@kcho.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
神戸市立医療センター中央市民病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | 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
| 2020 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cohort study
Management information
Registered date
| 2020 | Year | 11 | Month | 12 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048441
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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