UMIN-CTR Clinical Trial

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

Dysphagia

Classification by specialty

Medicine in general	Surgery in general	Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

30

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2017

Year

12

Month

27

Day

Last modified on

2021

Year

11

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034944