UMIN-CTR Clinical Trial

Basic information
Public title	Prevalence and associated factors of sarcopenia dysphagia: multicenter database study
Acronym	Prevalence and associated factors of sarcopenia dysphagia.
Scientific Title	Prevalence and associated factors of sarcopenia dysphagia: multicenter database study
Scientific Title:Acronym	Prevalence and associated factors of sarcopenia dysphagia: multicenter database study
Region	Japan

Condition
Condition	Patients aged 20 years or older with dysphagia
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The prevalence of dysphagia in sarcopenia other than in acute-care hospitals is unknown because there are no academic presentations or papers. Therefore, it is important to know the prevalence of eating and swallowing disorders in sarcopenia in a number of settings, including acute care hospitals, convalescent rehabilitation hospitals, elderly health facilities, and home care. Systemic sarcopenia and undernutrition are known to be associated with sarcopenia dysphagia, but other factors are unknown. A multicenter longitudinal study was designed to investigate the prevalence of eating and swallowing disorders in sarcopenia and the associated factors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	severity of dysphagia
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients aged 20 years or older with dysphagia. FILS of 8 or less (I take three meals, except for those that are particularly difficult to eat.) between April 2018 and December 2020 are covered. Subjects are 20 years of age or older at the time of the first survey.
Key exclusion criteria	None
Target sample size	900

Research contact person
Name of lead principal investigator	1st name Hidetaka Middle name Last name Wakabayashi
Organization	Yokohama City University Medical Center
Division name	Rehabilitaton medicine
Zip code	232-0024
Address	4 -57 Urafune-cho, Minami-ku, Yokohama-shi
TEL	045-261-5656
Email	ntnyf092@yahoo.co.jp

Public contact
Name of contact person	1st name Hidetaka Middle name Last name Wakabayashi
Organization	Nihon University Hospital
Division name	Rehabilitation medicine
Zip code	232-0024
Address	4 -57 Urafune-cho, Minami-ku, Yokohama-shi
TEL	045-261-5656
Homepage URL
Email	ntnyf092@yahoo.co.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	Yokohama City University Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Medical Center
Address	4 -57 Urafune-cho, Minami-ku, Yokohama-shi
Tel	045-261-5656
Email	ntnyf092@yahoo.co.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

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 12 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	467
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Submission of thesis
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	Main results already published
Date of protocol fixation	2019 Year 07 Month 11 Day
Date of IRB	2019 Year 09 Month 12 Day
Anticipated trial start date	2019 Year 09 Month 12 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational studies and multi-institutional database studies

Management information
Registered date	2019 Year 10 Month 12 Day
Last modified on	2022 Year 10 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043562