UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000026508
Receipt No. 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 (Ver. 8)

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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
Last 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
Email info@hriha.jp

Public contact
1st 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
Email tmori0117@yahoo.co.jp

Sponsor
Institute Hamamatsu City Rehabilitation Hospita
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030444