NCT05240599

Brief Summary

Swallowing is a set of functions that start with the acceptance of food and end with its delivery to the stomach. One of the most important problems associated with swallowing disorders is insufficient airway closure and the risk of aspiration. It is due to the inadequacy of laryngeal elevation that should occur during swallowing. Suprahyoid muscles are the most basic structures responsible for laryngeal elevation. Insufficient activation of the suprahyoid muscles causes insufficient laryngeal elevation. The suprahyoid muscles consist of a group of muscles located in the anterior region of the neck between the hyoid bone and the mandible. The muscles which forming SH muscles m. digastricus, m. stylohyoideus, m. mylohyoideus and m. geniohyoideus muscles work as a group. SH muscles play a primary role in controlling hyoid bone movement during swallowing due to their relationship with the hyoid bone. It has been reported that the muscle with the highest potential to move the hyoid anteriorly is the geniohyoid muscle, and the mylohyoid muscle has the highest potential to move the hyoid in the superior direction. In addition, in another study, it was stated that since the geniohyoid and mylohyoid muscles have greater structural potential than other SH muscles for anterior and superior displacement of the hyoid, respectively. By understanding the potential for hyoid excursion arising from the structural properties of these muscles, therapists can target specific muscles with exercises designed to promote hyolaryngeal elevation. Exercises such as Shaker exercise and resistance chin tuck in the literature either directly involve concentric training of the suprahyoid muscles or indirectly aim to gain strength by strengthening the neck flexors. In the light of the available evidence in the literature, eccentric training is also a viable method in swallowing rehabilitation. In eccentric training, the muscle is positioned by shortening its length. Eccentric training can be done by applying resistance to the jaw while the mouth is open and asking the mouth to be closed in a controlled manner against the resistance. In addition, swallowing exercise can be planned by adjusting the mouth opening and placing the SH muscles at the most appropriate angle to generate force. The aim of this study is to compare the effects of these three different exercises on suprahyoid muscle activation, muscle strength, dysphagia limit and perceived exertion level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 16, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 7, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

January 24, 2022

Last Update Submit

November 6, 2024

Conditions

Keywords

ElectromyographyExercise TrainingDysphagia Limit

Outcome Measures

Primary Outcomes (2)

  • Muscle Activation

    In our study, dual-channel DELSYS Trigno Duo sensors integrated into the software called DELSYS Trigno Lite System will be used. While measuring voluntary muscle activations in the superficial emg device, the values taken will be recorded in microvolts. For superficial emg recording, the high filter pass will be calculated as 20 Hz, the low filter pass as 2 kHz, and the received signal will be amplified 200 times. The signal transition interval will be set to 20 mV.

    Change from baseline muscle activation at 4 weeks and 8 weeks

  • Muscle Strength

    Individuals participating in the study will be asked to sit on their backs in an upright position at 90 degrees. Participants' heads will be fixed in a neutral position to prevent possible cervical flexion movement. The head of the digital dynamometer named Jtech Medical Industries Commander Muscle Testing 7633s, which is compatible with the chin area, will be placed under the chin of the participant and the participant will be asked to open his mouth vigorously for 10 seconds against the resistance. This movement will be repeated 3 times, with a 60-second listening period in between. And the maximum and average values taken will be recorded in Newtons.

    Change from baseline muscle strength at 4 weeks and 8 weeks

Secondary Outcomes (2)

  • Dysphagia Limit

    Change from baseline dysphagia limit at 4 weeks and 8 weeks

  • Perceived Exertion Level

    Change from baseline perceived exertion level at 4 weeks and 8 weeks

Study Arms (3)

Shaker

EXPERIMENTAL

Shaker exercises consist of isotonic and isometric contractions of the neck flexor muscles. Participants will be asked to lie on their back with their knees straight. Participants will first wait for 60 seconds by lifting their head and looking at their feet. He will repeat the movement three times in total, resting for 60 seconds in between. Then, the participants will raise their heads again, look at the toes, and put their head back on the bed without waiting. By repeating this movement 30 times in total, the exercise program will be completed. Individuals will perform this exercise, which consists of isometric components to be repeated 3 times and isotonic components to be performed once, in 3 times per day.

Other: Exercise Training

Chin Tuck Against Resistance

EXPERIMENTAL

In this exercise, participants have to place an inflatable ball with a diameter of 12 cm between their chin and sternum. This exercise has two subcomponents, isotonic and isometric. In the isometric component, individuals must compress the ball with maximum force between their chin and sternum, hold for 60 seconds, and rest for 60 seconds. One should repeat this isometric component 3 times. In the isotonic parameter, on the other hand, the participants must slowly squeeze the ball between their chin and sternum 30 times with the maximum force they can do. Participants will perform the exercise in an upright sitting position on a back-supported chair. Individuals will perform this exercise, which consists of isometric components to be repeated 3 times and isotonic components repeated 10 times in 3 setsand 3 times per day.

Other: Exercise Training

Eccentric Chin Closure

EXPERIMENTAL

This exercise will be performed in the form of closing the chin against the manual resistance to be given from the tip of the mandible, starting from the maximum voluntary mouth opening. In this way, eccentric contraction will be created as the suprahyoid muscles will move from the shortest position to the longest position with resistance. Participants will perform the exercise by maintaining the upright posture in the upright sitting position on the back-supported chair. Volunteers will perform this exercise with 10 repetitions in 3 sets and 3 times per day.

Other: Exercise Training

Interventions

Exercise training will be applied 3 times a day for 8 weeks.

Chin Tuck Against ResistanceEccentric Chin ClosureShaker

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18 - 35,
  • Volunteering to participate in the study,
  • Getting less than 3 points from the T-EAT-10 (Turkish Eating Assessment Test).

You may not qualify if:

  • Having disc herniation, mechanical neck pain or any pathology in the cervical region.
  • Having a temporamandibular joint problem that may affect joint biomechanics and muscle functions.
  • Having any neurological or systemic disease,
  • Having undergone head and neck surgery or received radiotherapy.
  • Dischart Criteria
  • Individuals who accepted the study and then stopped participating in the study
  • Individuals who did not attend the assessments
  • Individuals missing 5 days from the weekly follow-up of exercise sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (TĂ¼rkiye)

Location

Related Publications (28)

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    PMID: 19227198BACKGROUND
  • Pearson WG Jr, Hindson DF, Langmore SE, Zumwalt AC. Evaluating swallowing muscles essential for hyolaryngeal elevation by using muscle functional magnetic resonance imaging. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):735-40. doi: 10.1016/j.ijrobp.2012.07.2370. Epub 2012 Sep 18.

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  • Ludlow CL, Humbert I, Saxon K, Poletto C, Sonies B, Crujido L. Effects of surface electrical stimulation both at rest and during swallowing in chronic pharyngeal Dysphagia. Dysphagia. 2007 Jan;22(1):1-10. doi: 10.1007/s00455-006-9029-4.

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    PMID: 18940636BACKGROUND
  • Pearson WG Jr, Langmore SE, Zumwalt AC. Evaluating the structural properties of suprahyoid muscles and their potential for moving the hyoid. Dysphagia. 2011 Dec;26(4):345-51. doi: 10.1007/s00455-010-9315-z. Epub 2010 Nov 11.

    PMID: 21069388BACKGROUND
  • Burnett TA, Mann EA, Stoklosa JB, Ludlow CL. Self-triggered functional electrical stimulation during swallowing. J Neurophysiol. 2005 Dec;94(6):4011-8. doi: 10.1152/jn.00025.2005. Epub 2005 Aug 17.

    PMID: 16107520BACKGROUND
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    PMID: 18230851BACKGROUND
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    PMID: 10718448BACKGROUND
  • Jacob P, Kahrilas PJ, Logemann JA, Shah V, Ha T. Upper esophageal sphincter opening and modulation during swallowing. Gastroenterology. 1989 Dec;97(6):1469-78. doi: 10.1016/0016-5085(89)90391-0.

    PMID: 2583413BACKGROUND
  • Cook IJ, Dodds WJ, Dantas RO, Massey B, Kern MK, Lang IM, Brasseur JG, Hogan WJ. Opening mechanisms of the human upper esophageal sphincter. Am J Physiol. 1989 Nov;257(5 Pt 1):G748-59. doi: 10.1152/ajpgi.1989.257.5.G748.

    PMID: 2596608BACKGROUND
  • Steele CM, Bailey GL, Chau T, Molfenter SM, Oshalla M, Waito AA, Zoratto DC. The relationship between hyoid and laryngeal displacement and swallowing impairment. Clin Otolaryngol. 2011 Feb;36(1):30-6. doi: 10.1111/j.1749-4486.2010.02219.x.

    PMID: 21414151BACKGROUND
  • Kim Y, McCullough GH. Maximum hyoid displacement in normal swallowing. Dysphagia. 2008 Sep;23(3):274-9. doi: 10.1007/s00455-007-9135-y. Epub 2007 Oct 26.

    PMID: 17962998BACKGROUND
  • Logemann JA, Rademaker A, Pauloski BR, Kelly A, Stangl-McBreen C, Antinoja J, Grande B, Farquharson J, Kern M, Easterling C, Shaker R. A randomized study comparing the Shaker exercise with traditional therapy: a preliminary study. Dysphagia. 2009 Dec;24(4):403-11. doi: 10.1007/s00455-009-9217-0. Epub 2009 May 27.

    PMID: 19472007BACKGROUND
  • Yoon WL, Khoo JK, Rickard Liow SJ. Chin tuck against resistance (CTAR): new method for enhancing suprahyoid muscle activity using a Shaker-type exercise. Dysphagia. 2014 Apr;29(2):243-8. doi: 10.1007/s00455-013-9502-9. Epub 2013 Dec 15.

    PMID: 24337867BACKGROUND
  • Easterling C, Grande B, Kern M, Sears K, Shaker R. Attaining and maintaining isometric and isokinetic goals of the Shaker exercise. Dysphagia. 2005 Spring;20(2):133-8. doi: 10.1007/s00455-005-0004-2.

    PMID: 16172822BACKGROUND
  • Sze WP, Yoon WL, Escoffier N, Rickard Liow SJ. Evaluating the Training Effects of Two Swallowing Rehabilitation Therapies Using Surface Electromyography--Chin Tuck Against Resistance (CTAR) Exercise and the Shaker Exercise. Dysphagia. 2016 Apr;31(2):195-205. doi: 10.1007/s00455-015-9678-2. Epub 2016 Feb 2.

    PMID: 26837612BACKGROUND
  • Gao J, Zhang HJ. Effects of chin tuck against resistance exercise versus Shaker exercise on dysphagia and psychological state after cerebral infarction. Eur J Phys Rehabil Med. 2017 Jun;53(3):426-432. doi: 10.23736/S1973-9087.16.04346-X. Epub 2016 Nov 10.

    PMID: 27830923BACKGROUND
  • Friden J. Changes in human skeletal muscle induced by long-term eccentric exercise. Cell Tissue Res. 1984;236(2):365-72. doi: 10.1007/BF00214240.

    PMID: 6733763BACKGROUND
  • Roig M, O'Brien K, Kirk G, Murray R, McKinnon P, Shadgan B, Reid WD. The effects of eccentric versus concentric resistance training on muscle strength and mass in healthy adults: a systematic review with meta-analysis. Br J Sports Med. 2009 Aug;43(8):556-68. doi: 10.1136/bjsm.2008.051417. Epub 2008 Nov 3.

    PMID: 18981046BACKGROUND
  • Kilinc HE, Arslan SS, Demir N, Karaduman A. The Effects of Different Exercise Trainings on Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit in Healthy Subjects. Dysphagia. 2020 Aug;35(4):717-724. doi: 10.1007/s00455-019-10079-w. Epub 2019 Nov 25.

    PMID: 31768618BACKGROUND
  • Demir N, Serel Arslan S, Inal O, Karaduman AA. Reliability and Validity of the Turkish Eating Assessment Tool (T-EAT-10). Dysphagia. 2016 Oct;31(5):644-9. doi: 10.1007/s00455-016-9723-9. Epub 2016 Jul 12.

    PMID: 27405421BACKGROUND
  • Ws Coriolano Md, R Belo L, Carneiro D, G Asano A, Al Oliveira PJ, da Silva DM, G Lins O. Swallowing in patients with Parkinson's disease: a surface electromyography study. Dysphagia. 2012 Dec;27(4):550-5. doi: 10.1007/s00455-012-9406-0. Epub 2012 May 27.

    PMID: 22644084BACKGROUND
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    PMID: 25088732BACKGROUND
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    PMID: 24240663BACKGROUND
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    PMID: 4721013BACKGROUND
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    PMID: 12430990BACKGROUND
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    PMID: 15878476BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Emre CENGIZ, MSc, PhD(c)

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 15, 2022

Study Start

May 16, 2023

Primary Completion

September 16, 2023

Study Completion

May 1, 2024

Last Updated

November 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations