Study of Tongue Strengthening for Swallowing Problems

Study Overview
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Brief Summary
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This study is a multisite, randomized clinical trial to determine the effectiveness of an 8-week rehabilitative exercise regime performed by patients with swallowing problems, termed dysphagia, compared to a control group of patients with swallowing problems who do not exercise, but receive standard clinical care. One hundred male and female patients will take part in this study from eight participating facilities around the country.

Official Title
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Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia

Conditions
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Dysphagia

Intervention / Treatment
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* Behavioral: Isometric Progressive Resistance Oropharyngeal Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referral by a physician for swallowing evaluation because of suspected dysphagia complaint of difficulty swallowing aspiration or penetration of the laryngeal vestibule with liquids or semisolids OR post-swallow residue visible in the oral cavity, valleculae, or pharynx that is instrumentally documented by a participating SLP during a standard clinical videofluoroscopic swallowing study between the ages of 21 and 95 ability to perform the exercise protocol independently or with the assistance of a caregiver physician approval of medical stability to participate decision-making capacity to provide informed consent (confirmed through discussion between the participating SLP and the subject's primary physician) Exclusion Criteria: degenerative neuromuscular disease poorly controlled psychosis patient unable to complete the exercise program allergy to barium (used in videofluoroscopic swallowing assessment)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Clinical Care<br>Standard swallowing intervention is that which is identified by the SLP as appropriate to treat the patient's dysphagia and is in common clinical practice. Such treatment would consist of dietary or postural compensatory strategies (i.e., chin down posture while swallowing). | |
| Experimental: Standard Clinical Care Plus Isometric Lingual Exercise<br>Standard Clinical Care Plus 8-week Isometric Lingual Exercise Regimen. The isometric tongue exercises will be completed using the Madison Oral Strengthening Therapeutic (MOST) device. Baseline maximum lingual pressure will be obtained at the anterior and posterior sensors independently by gathering two sets of data (3 MOST device trials) at each site (anterior and posterior) that differ by less that 5%. During week one of the regimen, the target value of each repetition will be 60% of the maximum baseline pressure. For the remaining seven weeks of the program, the target value will be increased to 80% of the maximum. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated. | Behavioral: Isometric Progressive Resistance Oropharyngeal Therapy<br>* Tongue press exercises consist of pressing the tongue against the sensors. Isometric exercises will focus on the anterior and posterior sensor. Subjects will be given a target pressure value for both the anterior and posterior sensor locations for which to aim when doing the exercises. Visual feedback on the display will signal the subject that they have attained their target pressure goal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Swallow Function | The Primary Outcome will be objectively measured from videofluoroscopic images. Improvement in swallowing is defined as a reduction in either the average Penetration/Aspiration scale score or the average Residue Scale score over the 11 swallows (3 3-ml thin liquid, 3 10-ml thin liquid, 3 3-ml semi-solid and 2 3-ml thin liquid effortful) combined with no increase in the other average score. If the series of swallows is terminated prematurely, the worst possible score (8 for Penetration/Aspiration Scale, 2 for residue) will be assigned for all uncompleted swallows. | Baseline and 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Penetration/Aspiration Scale score | An 8-point scale indicating occurrence, depth, clearance and patient response to material invading the laryngeal vestibule or trachea. The Penetration/Aspiration Scale score will be objectively measured from videofluoroscopic images. | Baseline and Week 8 | 
| Change in Residue Scale score | A 3-point scale to measure post-swallow barium residue on a videofluoroscopic image. The Residue Scale score will be objectively measured from videofluoroscopic images. | Baseline and Week 8 | 
| Change in Bolus Transit Times | Durational measures of bolus flow through the oropharynx from videofluoroscopic images. | Baseline and 8 Weeks | 
| Change in Isometric Lingual Pressure | Maximum tongue press measured using the FDA registered Madison Oral Strenthening Therapeutic (MOST) device. | Baseline and 8 Weeks | 
| Change in Quality of Life | Each subject will complete a questionnaire detailing his/her quantity and variety of nutritional intake and also will complete a questionnaire (Swal-Qol) about the impact of dysphagia on his/her quality of life at baseline and week 8. It takes approximately 10 minutes to complete each questionnaire. | Baseline and 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deglutition, Exercise