UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009249 |
|---|---|
| Receipt number | R000010860 |
| Scientific Title | The effects of viscosities on mastication and swallowing in frail elderlies |
| Date of disclosure of the study information | 2012/11/03 |
| Last modified on | 2015/07/08 08:55:50 |
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Basic information
Public title
The effects of viscosities on mastication and swallowing in frail elderlies
Acronym
The effects of viscosities on mastication and swallowing in frail elderlies
Scientific Title
The effects of viscosities on mastication and swallowing in frail elderlies
Scientific Title:Acronym
The effects of viscosities on mastication and swallowing in frail elderlies
Region
| Japan |
Condition
Condition
people with dysphagia
Classification by specialty
| Medicine in general | Rehabilitation medicine | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When eating two-phase food including solid and liquid, the liquid component enters the hypopharynx frequently (Saitoh et al., 2007). When the liquid is in the hypopharynx, the larynx is open, which increases a risk of aspiration.
In our priliminary study, we revealed that increased viscosity in two-phase food significantly delayed food transport to the pharynx (Matsuo et al., 2012).
The purpose of this study was to examine the effects of increased viscosities in two-phase food on mastication, food transport and swallowing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
bolus location at swallow onset, masticatory time, presense of aspiration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
presense of dysphagia
Interventions/Control_2
no dysphagia
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
normal old people and frail elderly in nursing homes
Key exclusion criteria
i) hemorrhagic diathesis, ii) low cognition, iii) alergic to the test food, iV) severe dysphagia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Matsuo |
Organization
Fujita Health University, School of Medicine
Division name
Department of Dentistry
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake
TEL
0562-93-2000
kmatsuo@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Matsuo |
Organization
Fujita Health Unversity
Division name
Department of Dentistry
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake
TEL
0562-93-2000
Homepage URL
kmatsuo@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health Unversity
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 02 | Day |
Last modified on
| 2015 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010860
