Tongue Motor Recruitment During Exercise

NCT ID: NCT02687737

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-12-31

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.

Detailed Description

This study will measure tongue muscle activation using fine wire EMG placed into the tongue muscle (underneath the chin) during swallowing and breathing exercises. A neurologist trained in EMG will perform all procedures to ensure best placement and minimize discomfort of the participant. While the needle is in place, the participant will complete a series of swallowing tasks and breathing exercises using a small, handheld training device. All swallowing and breathing tasks will be viewed under x-ray in order to see the movement and timing of the tongue and swallowing muscles during each task. Participation in the study will take one, one-hour visit to the Shands Dental Tower lab spaces where all procedures will be completed.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

The 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)

Group Type: EXPERIMENTAL

Electromyography

Intervention Type: PROCEDURE

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.

Maximum expiratory pressure

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks.

Swallowing Tasks

Intervention Type: BEHAVIORAL

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.

Interventions

Electromyography

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.

Intervention Type: PROCEDURE

Maximum expiratory pressure

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.

Intervention Type: PROCEDURE

Videofluoroscopy

Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks.

Intervention Type: PROCEDURE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

EMG; MEP; Videofluoroscopy and Barium

Eligibility Criteria

Inclusion Criteria

• No known major disease, disorder or medical conditions

Exclusion Criteria

• Currently on anticoagulant therapy
• Has a bleeding/anticoagulant disorder or disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily K Plowman, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

University of Florida College of Public Health and Health Professions

Locations

Shands Hospital at the University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18728114 (View on PubMed)

Trinder 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.

Reference Type: BACKGROUND

PMID: 23797183 (View on PubMed)

Other Identifiers

IRB201600120

Identifier Type: -

Identifier Source: org_study_id