Study of Tongue Strengthening for Swallowing Problems

NCT01570023 | Completed

• 1 other identifier: 2011-0518
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 9

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.

Conditions

Dysphagia

Keywords

Deglutition; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Penetration/Aspiration Scale score

  Baseline and Week 8

• Change in Residue Scale score

  Baseline and Week 8

• Change in Bolus Transit Times

  Baseline and 8 Weeks

• Change in Isometric Lingual Pressure

  Baseline and 8 Weeks

• Change in Quality of Life

  Baseline and 8 Weeks

Study Arms (2)

Standard Clinical Care

NO INTERVENTION

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 Isometric Lingual Exercise

EXPERIMENTAL

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

Interventions

Isometric Progressive Resistance Oropharyngeal Therapy BEHAVIORAL

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.

Standard Clinical Care Plus Isometric Lingual Exercise

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• degenerative neuromuscular disease
• poorly controlled psychosis
• patient unable to complete the exercise program
• allergy to barium (used in videofluoroscopic swallowing assessment)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (9)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Minneapolis Veterans Administration Health Care System

Minneapolis, Minnesota, 55417, United States

Location

Silvercrest Center for Nursing and Rehabilitation

Briarwood, New York, 11435, United States

Location

New York Hospital Queens

Flushing, New York, 11355, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

University of Pittsburgh Medical Center Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

University of Pittsburgh Medical Center Presbyterian University Hospital

Pittsburgh, Pennsylvania, 15237, United States

Location

VA Medical Center-Memphis

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Behavior

Study Officials

• JoAnne Robbins, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 4, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

US (9)