UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017289 |
|---|---|
| Receipt number | R000019789 |
| Scientific Title | Risk factor analyses for sarcopenic dysphagia |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2018/07/17 15:29:34 |
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Basic information
Public title
Risk factor analyses for sarcopenic dysphagia
Acronym
Risk factor analyses for sarcopenic dysphagia
Scientific Title
Risk factor analyses for sarcopenic dysphagia
Scientific Title:Acronym
Risk factor analyses for sarcopenic dysphagia
Region
| Japan |
Condition
Condition
Hospitalized geriatric patients
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate risk factors for dysphagia which caused by post-NPO
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decline of swallowing ability
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized geriatric patients
1) aged 65 yr or older
2) having normal swallowing function prior to onset
3) restricted oral intake for 48 hours after admission
Key exclusion criteria
1) acute stroke
2) contraindication or difficulties for measuring body composition
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Maeda |
Organization
Tamana Regional Health Medical Center
Division name
Dept. of Nutrition and Dysphagia Rehabilitation
Zip code
Address
2172 Tamana, Tamana, Kumamoto-pref., Japan
TEL
+81968725111
maeda4work@tng.bbiq.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Maeda |
Organization
Tamana Regional Health Medical Center
Division name
Dept. of Nutrition and Dysphagia Rehabilitation
Zip code
Address
2172 Tamana, Tamana, Kumamoto-pref., Japan
TEL
+81968725111
Homepage URL
maeda4work@tng.bbiq.jp
Sponsor or person
Institute
Tamana Regional Health Medical Center
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
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
玉名地域保健医療センター（熊本県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 06 | Month | 17 | Day |
Other
Other related information
We planed to evaluate swallowing function using Functional Oral Intake Scale.
Management information
Registered date
| 2015 | Year | 04 | Month | 27 | Day |
Last modified on
| 2018 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019789
| Research Plan | |
|---|---|
| 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 |
