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Study of Tongue Strengthening for Swallowing Problems

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isometric Progressive Resistance Oropharyngeal Therapy
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring Deglutition, Exercise

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern University
  • Central Baptist Hospital
  • Minneapolis Veterans Administration Health Care System
  • Silvercrest Center for Nursing and Rehabilitation
  • New York Hospital Queens
  • Beth Israel Medical Center
  • University of Pittsburgh Medical Center Passavant
  • University of Pittsburgh Medical Center Presbyterian University Hospital
  • VA Medical Center-Memphis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Clinical Care

Standard Clinical Care Plus Isometric Lingual Exercise

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change in Bolus Transit Times
Durational measures of bolus flow through the oropharynx from videofluoroscopic images.
Change in Isometric Lingual Pressure
Maximum tongue press measured using the FDA registered Madison Oral Strenthening Therapeutic (MOST) device.
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.

Full Information

First Posted
March 27, 2012
Last Updated
October 9, 2015
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01570023
Brief Title
Study of Tongue Strengthening for Swallowing Problems
Official Title
Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Deglutition, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Clinical Care
Arm Type
No Intervention
Arm Description
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).
Arm Title
Standard Clinical Care Plus Isometric Lingual Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Isometric Progressive Resistance Oropharyngeal Therapy
Intervention Description
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 Measure Information:
Title
Change in Swallow Function
Description
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.
Time Frame
Baseline and 8 Weeks
Secondary Outcome Measure Information:
Title
Change in Penetration/Aspiration Scale score
Description
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.
Time Frame
Baseline and Week 8
Title
Change in Residue Scale score
Description
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.
Time Frame
Baseline and Week 8
Title
Change in Bolus Transit Times
Description
Durational measures of bolus flow through the oropharynx from videofluoroscopic images.
Time Frame
Baseline and 8 Weeks
Title
Change in Isometric Lingual Pressure
Description
Maximum tongue press measured using the FDA registered Madison Oral Strenthening Therapeutic (MOST) device.
Time Frame
Baseline and 8 Weeks
Title
Change in Quality of Life
Description
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.
Time Frame
Baseline and 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoAnne Robbins, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Minneapolis Veterans Administration Health Care System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Silvercrest Center for Nursing and Rehabilitation
City
Briarwood
State/Province
New York
ZIP/Postal Code
11435
Country
United States
Facility Name
New York Hospital Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
University of Pittsburgh Medical Center Passavant
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
University of Pittsburgh Medical Center Presbyterian University Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
VA Medical Center-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

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Study of Tongue Strengthening for Swallowing Problems

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