UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030602 |
|---|---|
| Receipt number | 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 | 2021/11/01 21:53:16 |
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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 | 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
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
s.hasegawa.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034944
