UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026508 |
|---|---|
| Receipt number | R000030444 |
| Scientific Title | Development and validity of a diagnostic algorithm for sarcopenic dysphagia |
| Date of disclosure of the study information | 2017/03/20 |
| Last modified on | 2019/04/22 09:09:28 |
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Basic information
Public title
Development and validity of a diagnostic algorithm for sarcopenic dysphagia
Acronym
Diagnostic algorithm for sarcopenic dysphagia
Scientific Title
Development and validity of a diagnostic algorithm for sarcopenic dysphagia
Scientific Title:Acronym
Diagnostic algorithm for sarcopenic dysphagia
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and validity of a diagnostic algorithm for sarcopenic dysphagia
Basic objectives2
Others
Basic objectives -Others
Validity of a diagnostic algorithm for sarcopenic dysphagia
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Validity of a diagnostic algorithm for sarcopenic dysphagia
Key secondary outcomes
Prevalence of sarcopenic dysphagia
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inpatients aged 65 years and older
Key exclusion criteria
Patients can not obey commands.
General conditions are not appropriate for assessment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Fujishima |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
director
Zip code
433-8511
Address
1-6-1, Wagokita, Naka-ku Hamamatsu-shi, Shizuoka, 433-8511, Japan
TEL
053-471-8331
info@hriha.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Mori |
Organization
Southern Tohoku General Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
963-8563
Address
7-115, Yatsuyamada, Koriyama-shi, Fukushima, 963-8563, Japan
TEL
024-934-5322
Homepage URL
tmori0117@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu City Rehabilitation Hospita
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Dysphagia Rehabilitation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Wakakusa-Tatsuma Rehabilitation Hospital
Yokohama City University Medical Center
Southern Tohoku General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu City Rehabilitation Hospital
Address
1-6-1, Wagokita, Naka-ku Hamamatsu-shi, Shizuoka, 433-8511, Japan
Tel
053-471-8331
info@hriha.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
浜松市リハビリテーション病院
わかくさ竜間リハビリテーション病院（大阪府）
横浜市立大学附属市民総合医療センター（神奈川県）
総合南東北病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.jamda.2017.11.007
Publication of results
Published
Result
URL related to results and publications
:https://doi.org/10.1016/j.jamda.2017.11.007
Number of participants that the trial has enrolled
72
Results
The group with sarcopenic dysphagia had a significantly lower cross-sectional area and area of brightness of the tongue muscle than that observed in the group without sarcopenic dysphagia. Multivariate logistic regression analysis showed that the area of the tongue muscle and its area of brightness were independent risk factors for sarcopenic dysphagia.
Results date posted
| 2019 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 06 | Month | 01 | Day |
Baseline Characteristics
Patients with dysphagia in hospitals and facilities.
Participant flow
Patients applied diagnostic algorithm for sarcopenic dysphagia.
Adverse events
none
Outcome measures
sex,age,height,weight,gait speed, culf circumference,skeletal mass,swallowing function,area and brightness for tongue and geniohyoid muscle
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 08 | Day |
Other
Other related information
Study design: cross-sectional study
Recruit: Inpatients aged 65 years and older
Term of recruit: 9/2016-4/2017
Measurement item: diagnosis, age, height, weight, BMI, muscle strength, muscle mass gait speed, swallowing ability, oral intake level, maximum tongue pressure, nutritional status, outcomes of diagnostic algorithm for sarcopenic dysphagia, muscle mass of swallowing muscles
Management information
Registered date
| 2017 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030444
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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