Tongue Motor Recruitment During Exercise
Genioglossus Motor Recruitment During Swallowing and Expiratory Loading Exercises
1 other identifier
interventional
30
1 country
1
Brief Summary
The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There are few therapeutic options offered to these individuals. One more recent therapeutic option is Expiratory Muscle Strength Training (EMST), which has been used successfully to maintain or increase expiratory force generating pressures, cough function, and swallowing in a number of disease populations. Recently, the investigators have noted improvements in oral transit time during swallowing in individuals with Amyotrophic Lateral Sclerosis (ALS) that could potentially be attributed to improved base of tongue functioning and muscle activation. There has been one study that demonstrated that breathing training resulted in increased and prolonged submental (under the chin) muscle activation as evidenced by surface electromyography. However, no studies have investigated the activation of the tongue muscles during various swallowing and breathing exercises. A small needle electrode (fine wire EMG) is standard of care in diagnosing muscular diseases because it can determine amount of muscle recruitment for muscles throughout the body. This aim of this research study is to examine the effects of breathing exercises and swallowing exercises on tongue muscle activity in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 5, 2017
January 1, 2017
7 months
February 9, 2016
January 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Electromyography (EMG) will be used to analyze genioglossus muscle movement
Electromyography (EMG) activity will be recorded via standard concentric needle electrodes inserted into the genioglossus muscle. Maximum muscle activation will be recorded and analyzed to determine difference between tasks using the genioglossus muscle.
Baseline
Kinematic Swallowing Measurements will be used to analyze a normal movement of swallowing
Kinematic swallowing measurements is an objective analysis of videofluoroscopy. This involves capturing and manipulating digital images with computer technology to make exact timing measures of bolus flow and movement of structures, as well as spatial measurements of distance and area against reference points.
Baseline
Study Arms (1)
Exercise
EXPERIMENTALThe participants will have the following tests performed: Maximum Expiratory Pressure (MEP), insertion of a fine-wire electromyography (EMG) electrode into the mid-line base of the tongue, will complete swallowing tasks and breathing tasks under Videofluoroscopy (fluoroscopy on only during the actual task)
Interventions
During the fine wire electromyography (EMG), the participant will be asked to complete breathing exercises at 50% and 75% of their maximum capacity (determined prior to fine wire EMG using manometry) to determine activation and recruitment of genioglossus muscle.
The participants' maximum expiratory pressure (MEP) will be assessed using a hand-held digital manometer (MP01, Micro Direct Inc.). The subject will be standing and while wearing a nose clip be asked to blow out as hard and fast as they can to determine their MEP. This will be completed a maximum of three times to obtain values within close range of one another.
Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks.
These include: an anterior tongue press to the alveolar ridge (behind the front molars), a saliva swallow, a 10 mL barium swallow, a 10 mL barium "hard" swallow (i.e. swallowing with extra effort), and two breathing exercise trials at 50% MEP and 75% MEP.
Eligibility Criteria
You may qualify if:
- No known major disease, disorder or medical conditions
You may not qualify if:
- Currently on anticoagulant therapy
- Has a bleeding/anticoagulant disorder or disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shands Hospital at the University of Florida
Gainesville, Florida, 32611, United States
Related Publications (2)
Wheeler-Hegland KM, Rosenbek JC, Sapienza CM. Submental sEMG and hyoid movement during Mendelsohn maneuver, effortful swallow, and expiratory muscle strength training. J Speech Lang Hear Res. 2008 Oct;51(5):1072-87. doi: 10.1044/1092-4388(2008/07-0016). Epub 2008 Aug 26.
PMID: 18728114BACKGROUNDTrinder J, Woods M, Nicholas CL, Chan JK, Jordan AS, Semmler JG. Motor unit activity in upper airway muscles genioglossus and tensor palatini. Respir Physiol Neurobiol. 2013 Sep 15;188(3):362-9. doi: 10.1016/j.resp.2013.06.011. Epub 2013 Jun 21.
PMID: 23797183BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily K Plowman, PhD, CCC-SLP
University of Florida College of Public Health and Health Professions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2016
First Posted
February 22, 2016
Study Start
May 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 5, 2017
Record last verified: 2017-01