Clinical trial NCT01570023: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Deglutition
Exercise
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Swallow Function
timeFrame: Baseline and 8 Weeks
Secondary outcomes:
measure: Change in Penetration/Aspiration Scale score
timeFrame: Baseline and Week 8
measure: Change in Residue Scale score
timeFrame: Baseline and Week 8
measure: Change in Bolus Transit Times
timeFrame: Baseline and 8 Weeks
measure: Change in Isometric Lingual Pressure
timeFrame: Baseline and 8 Weeks
measure: Change in Quality of Life
timeFrame: Baseline and 8 Weeks
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Minneapolis
country: United States
facility: Minneapolis Veterans Administration Health Care System
state: Minnesota
city: Briarwood
country: United States
facility: Silvercrest Center for Nursing and Rehabilitation
state: New York
city: Flushing
country: United States
facility: New York Hospital Queens
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Passavant
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian University Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: VA Medical Center-Memphis
state: Tennessee
Study officials:
affiliation: University of Wisconsin, Madison
name: JoAnne Robbins, PhD
role: PRINCIPAL_INVESTIGATOR
References: