Study of Tongue Strengthening for Swallowing Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01570023
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Dysphagia Behavioral: Isometric Progressive Resistance Oropharyngeal Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia
Study Start Date : April 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Standard Clinical Care
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
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
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.

Primary Outcome Measures :
  1. Change in Swallow Function [ Time Frame: 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 Outcome Measures :
  1. Change in Penetration/Aspiration Scale score [ Time Frame: 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.

  2. Change in Residue Scale score [ Time Frame: 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.

  3. Change in Bolus Transit Times [ Time Frame: Baseline and 8 Weeks ]
    Durational measures of bolus flow through the oropharynx from videofluoroscopic images.

  4. Change in Isometric Lingual Pressure [ Time Frame: Baseline and 8 Weeks ]
    Maximum tongue press measured using the FDA registered Madison Oral Strenthening Therapeutic (MOST) device.

  5. Change in Quality of Life [ Time Frame: 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.

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Ages Eligible for Study:   21 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01570023

United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Minnesota
Minneapolis Veterans Administration Health Care System
Minneapolis, Minnesota, United States, 55417
United States, New York
Silvercrest Center for Nursing and Rehabilitation
Briarwood, New York, United States, 11435
New York Hospital Queens
Flushing, New York, United States, 11355
Beth Israel Medical Center
New York, New York, United States, 10003
United States, Pennsylvania
University of Pittsburgh Medical Center Passavant
Pittsburgh, Pennsylvania, United States, 15237
University of Pittsburgh Medical Center Presbyterian University Hospital
Pittsburgh, Pennsylvania, United States, 15237
United States, Tennessee
VA Medical Center-Memphis
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: JoAnne Robbins, PhD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT01570023     History of Changes
Other Study ID Numbers: 2011-0518
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by University of Wisconsin, Madison:

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases