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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030602
Receipt No. R000034944
Scientific Title A new exercise which may improve the forward displacement of the hyoid bone during swallowing in community dwelling elderly people : A before-after study
Date of disclosure of the study information 2017/12/30
Last modified on 2018/12/28

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Basic information
Public title A new exercise which may improve the forward displacement of the hyoid bone during swallowing in community dwelling elderly people : A before-after study
Acronym A new exercise which may improve the forward displacement of the hyoid bone during swallowing in community dwelling elderly people : A before-after study
Scientific Title A new exercise which may improve the forward displacement of the hyoid bone during swallowing in community dwelling elderly people : A before-after study
Scientific Title:Acronym A new exercise which may improve the forward displacement of the hyoid bone during swallowing in community dwelling elderly people : A before-after study
Region
Japan

Condition
Condition Dysphagia
Classification by specialty
Medicine in general Surgery in general Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of the study is to explore the effectiveness of the jaw retraction exercise as a method to improve swallowing.

Our department has previously performed several studies concerning jaw-opening exercises. The results show that these exercises improve swallowing function. Specifically, we saw improvements in hyoid elevation, UES opening, and the time required for pharynx passage. However, in all the studies, we did not observe an increase in the forward displacement of the hyoid bone.
I would like to compare the results of this study to the previous studies, and determine the effectiveness of the jaw retraction exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Video Fluoroscopic Swallowing Exam (forward displacement of the hyoid bone)

*The second evaluation will take place 4 weeks after the first evaluation, during which time the volunteer will perform the Jaw retraction exercise on a daily basis.
Key secondary outcomes Age
Sex
Medical History
Hight
Weight

Dysphagia Assessment Questionnaire

Jaw-opening force
Jaw-opening speed
Tongue Pressure

Medical ultrasound (muscles around the oral cavity)

Video Fluoroscopic Swallowing Exam (The position of the hyoid bone at rest, elevation of the hyoid bone, hyoid movement time, UES opening width, pharynx passage time, the presence or absence of aspiration and food residue)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The participants will perform the jaw retraction exercise on a daily basis for 28 days(4 weeks) from the day after the first evaluation.

The jaw retraction exercise involves moving the mandible back towards your throat. The participants will be asked to hold the jaw in this position for 10 seconds. The teeth should not be in contact at any time. The participants will be asked to pay attention to strong tension on the suprahyoid muscles during the exercise. 1 set will consist of performing this exercise 5 times and resting for 10 seconds. The participants will be asked to perform 2 sets of the exercise every day.
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 Community dwelling elderly people of over 65 years of age who participated in a local health event.
Free and voluntary consent to participate in the study will be obtained.
Key exclusion criteria Those who meet one or more of the following criteria will be excluded from this study:
1. Those with an illness which is likely to cause dysphasia, and that illness is not well controlled or is in a acute state.
2. Those with an illness which is likely to cause dysphasia, and that illness is a progressive disease.
3. Has a medical history of one or more surgeries performed within the oral cavity or throat which may have structurally affected swallowing function.
4. Disorders of consciousness or dementia is present
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruka Tohara
Organization Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8549, JAPAN
TEL 81-3-5803-5559
Email haruka-t@rd5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shohei Hasegawa
Organization Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8549, JAPAN
TEL 81-3-5803-5559
Homepage URL
Email s.hasegawa.gerd@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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
Address
Tel
Email

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
2017 Year 12 Month 30 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
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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 27 Day
Last modified on
2018 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034944

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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