Dysphagia
Conditions
Keywords
Deglutition, Exercise
Brief summary
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.
Interventions
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Swallow Function | Baseline and 8 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Penetration/Aspiration Scale score | Baseline and Week 8 | 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. |
| Change in Residue Scale score | Baseline and Week 8 | 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. |
| Change in Bolus Transit Times | Baseline and 8 Weeks | Durational measures of bolus flow through the oropharynx from videofluoroscopic images. |
| Change in Isometric Lingual Pressure | Baseline and 8 Weeks | Maximum tongue press measured using the FDA registered Madison Oral Strenthening Therapeutic (MOST) device. |
| Change in Quality of Life | Baseline and 8 Weeks | 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. |
Countries
United States
Outcome results
None listed