UMIN-CTR Clinical Trial

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 Haruka Middle name Last name 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	113-8519
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 Shohei Middle name Last name Hasegawa
Organization	Tokyo Medical and Dental University
Division name	Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School
Zip code	113-8519
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	Institutional Review Board, Tokyo Medical and Dental University, Dental Hospital
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8549, JAPAN
Tel	81-3-5803-5559
Email	d-hyoka.adm@tmd.ac.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	2017 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/full/10.1111/ger.12595
Number of participants that the trial has enrolled	25
Results	Significant increases in peak anterior hyoid position (X value of position B) (p=0.07) and Jaw Opening Force (p=0.031) were observed. A significant increase in the extent of UES opening (p=0.04) was observed along with these changes. The peak superior hyoid position (Y value of position B) decreased significantly (p=0.09).
Results date posted	2021 Year 11 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 10 Month 20 Day
Baseline Characteristics	The median age of the participants was 77 years, with 44%, 36%, and 20% of the participants falling within the ranges of 65-74 years old (young-old), 75-84 years old (middle-old), and >=85 years old (oldest-old), respectively. Of the 25 participants, 15 (60%) participants were male, and 10 (40%) were female.
Participant flow	All 25 participants were able to perform two sets of exercises per day for the entire four-week training period.
Adverse events	No complaints of pain or discomfort in the temporomandibular region were reported during the training period.
Outcome measures	Significant increases in peak anterior hyoid position (X value of position B) (p=0.07) and Jaw Opening Force (p=0.031) were observed. A significant increase in the extent of UES opening (p=0.04) was observed along with these changes.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 27 Day
Date of IRB	2019 Year 03 Month 18 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
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	2021 Year 11 Month 01 Day

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