UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047887 |
|---|---|
| Receipt number | R000054596 |
| Scientific Title | Prevalence and functional prognosis of post-stroke cachexia |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/11/28 10:10:25 |
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Basic information
Public title
Prevalence, risk factors, and long-term prognosis of post-stroke cachexia: a survey study
Acronym
Prevalence, risk factors, and long-term prognosis of post-stroke cachexia: a survey study
Scientific Title
Prevalence and functional prognosis of post-stroke cachexia
Scientific Title:Acronym
Prevalence and functional prognosis of post-stroke cachexia
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the risk factors, and prognosis of cachexia in stroke patients.
Basic objectives2
Others
Basic objectives -Others
Prevalence
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional outcome measured by modified Rankin Scale at one year after stroke
Key secondary outcomes
Weight one year after stroke
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ischemic or hemorahhage stroke patients who were admitted at Itami Kousei Neurosurgical Hospital within 48 hours from stroke onset
Key exclusion criteria
Premorbid disability patients
Patients who having a serious disease (cardiac, respiratory, or urological disease, malignant tumor, musculoskeletal disease, or neuromuscular disease) other than stroke that causes a decline in physical function
Patients with a cardiac pacemaker
Patients with life-support devices
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Nozoe |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation, Department of Physical Therapy
Zip code
6580001
Address
morikitamachi, kobe higashinadaku
TEL
0784133584
masafumi.nozoe@gmail.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Nozoe |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation, Department of Physical Therapy
Zip code
6580001
Address
morikitamachi, kobe higashinadaku
TEL
0784133584
Homepage URL
masafumi.nozoe@gmail.com
Sponsor or person
Institute
Konan Women's University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Konan Women's Unversity, Reserch Ethical Comittie
Address
morikitamachi, kobe higashinadaku
Tel
0784133584
gakuken@konan-wu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2019030
Org. issuing International ID_1
Konan Women's Unversity, Reserch Ethical Comittie
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
伊丹恒生脳神経外科病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | 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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 05 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054596
