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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05240599
Other study ID # ECC Exercise
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 16, 2023
Est. completion date May 1, 2024

Study information

Verified date May 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Swallowing is a set of functions that start with the acceptance of food and end with its delivery to the stomach. The oral preparation consists of 4 phases, namely the oral, pharyngeal and esophageal phase. Swallowing disorder (dysphagia) is defined as problems occurring in at least one of the swallowing phases. 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 (SH) 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, these two muscles can be targeted for neuromuscular stimulation preferably. Studies have also shown that exercise can increase motor unit involvement for certain functions. 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. Interventions to protect the airway in case of swallowing disorder are aimed at increasing the hyolaryngeal elevation. SH muscles provide elevation of the hyolaryngeal complex and also support the opening of the upper esophageal sphincter (UES). The cricopharyngeal muscle, which opens the UES, is opened by the contraction of the SH muscles and the anterior-superior traction of the hyoid and larynx. Insufficient elevation of the hyoid and larynx causes insufficient opening of the UES, resulting in an increase in the amount of pharyngeal residue and the risk of aspiration. Superior hyolaryngeal excursion during swallowing is thought to contribute to airway protection, preventing aspiration. Anterior hyalaryngeal excursion is thought to be associated with the patency of the UES. 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. Shaker Exercises were the first exercise developed to increase suprahyoid muscle activation. This exercise, which is characterized by raising the patient's head in the supine position, has been accepted as one of the most basic exercises in dysphagia rehabilitation for many years. In the following years, the Chin Tuck Against Resistance (CTAR) exercise was developed due to the challenging protocol and positional discomfort of the Shaker exercise. In the CTAR exercise, the patient is asked to press a standard size and inflatable ball, which he puts under his chin, towards his sternum. CTAR has become the most commonly used exercise in dysphagia rehabilitation. 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. H0 Hypothesis: There is no difference between CTAR, Shaker and Eccentric Chin Closure exercises in terms of suprahyoid muscle activation, suprahyoid muscle strength, dysphagia limit and perceived exertion level in healthy individuals. H1 Hypothesis: There is a difference between CTAR, Shaker and Eccentric Chin Closure exercises in terms of suprahyoid muscle activation, suprahyoid muscle strength, dysphagia limit and perceived exertion level in healthy individuals.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date May 1, 2024
Est. primary completion date September 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (28)

Aydogdu I, Kiylioglu N, Tarlaci S, Tanriverdi Z, Alpaydin S, Acarer A, Baysal L, Arpaci E, Yuceyar N, Secil Y, Ozdemirkiran T, Ertekin C. Diagnostic value of "dysphagia limit" for neurogenic dysphagia: 17 years of experience in 1278 adults. Clin Neurophysiol. 2015 Mar;126(3):634-43. doi: 10.1016/j.clinph.2014.06.035. Epub 2014 Jul 8. — View Citation

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. — View Citation

Chen MJ, Fan X, Moe ST. Criterion-related validity of the Borg ratings of perceived exertion scale in healthy individuals: a meta-analysis. J Sports Sci. 2002 Nov;20(11):873-99. doi: 10.1080/026404102320761787. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Iida T, Tohara H, Wada S, Nakane A, Sanpei R, Ueda K. Aging decreases the strength of suprahyoid muscles involved in swallowing movements. Tohoku J Exp Med. 2013 Nov;231(3):223-8. doi: 10.1620/tjem.231.223. — View Citation

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. — View Citation

Kane RL, Bershadsky B, Rockwood T, Saleh K, Islam NC. Visual Analog Scale pain reporting was standardized. J Clin Epidemiol. 2005 Jun;58(6):618-23. doi: 10.1016/j.jclinepi.2004.11.017. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Matsuo K, Palmer JB. Anatomy and physiology of feeding and swallowing: normal and abnormal. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):691-707, vii. doi: 10.1016/j.pmr.2008.06.001. — View Citation

Molfenter SM, Steele CM. Physiological variability in the deglutition literature: hyoid and laryngeal kinematics. Dysphagia. 2011 Mar;26(1):67-74. doi: 10.1007/s00455-010-9309-x. Epub 2010 Oct 7. — View Citation

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. — View Citation

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. — View Citation

Robbins J, Butler SG, Daniels SK, Diez Gross R, Langmore S, Lazarus CL, Martin-Harris B, McCabe D, Musson N, Rosenbek J. Swallowing and dysphagia rehabilitation: translating principles of neural plasticity into clinically oriented evidence. J Speech Lang Hear Res. 2008 Feb;51(1):S276-300. doi: 10.1044/1092-4388(2008/021). — View Citation

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. — View Citation

Sivarao DV, Goyal RK. Functional anatomy and physiology of the upper esophageal sphincter. Am J Med. 2000 Mar 6;108 Suppl 4a:27S-37S. doi: 10.1016/s0002-9343(99)00337-x. — View Citation

Skinner JS, Hutsler R, Bergsteinova V, Buskirk ER. The validity and reliability of a rating scale of perceived exertion. Med Sci Sports. 1973 Summer;5(2):94-6. No abstract available. — View Citation

Sonoda N, Tamatsu Y. Observation on the attachment of muscles onto the hyoid bone in human adults. Okajimas Folia Anat Jpn. 2008 Nov;85(3):79-90. doi: 10.2535/ofaj.85.79. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 28 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Dysphagia Limit Individuals participating in the study will be asked to drink water in 1 ml, 3 ml, 5 ml, 10 ml, 15 ml, 20 ml, 25 ml and 30 ml glasses, respectively. Electricity and sound signals received during drinking water will be followed. The amount of water that people cannot drink in a single swallow (laryngeal elevation) will be determined as the dysphagia limit of that person. This will be decided if the electrical and sound signals received during swallowing the determined amount of water (simultaneously) occur more than once. Change from baseline dysphagia limit at 4 weeks and 8 weeks
Secondary Perceived Exertion Level After the participants are divided into groups, they will be evaluated in terms of perceived exertion level and pain at the beginning of the exercises, at the 4th week and at the end of the study. For this, the Borg Scale will be used. This scale was developed by Borg to measure the effort expended during physical exercise. The most widely used tool to measure perceived exertion or exercise intensity is Borg's perceived exertion scale. It is the adaptation of the patient's verbal fatigue level at rest and after exertion to the scale. The scale is between 6 and 20. While 6 patients did not feel any fatigue or strain, 20 corresponded to the highest level of fatigue. Change from baseline perceived exertion level at 4 weeks and 8 weeks
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