Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia - Full Text View

Purpose

The aim of this research study is to determine the effectiveness of: 1) a traditional therapy regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box) musculature and 2) a new therapeutic exercise, the Shaker exercise.

The primary objective of this 5-year project is to identify which of two therapy programs, the Shaker exercise versus traditional therapy, results in the largest number of stable, non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6 weeks of intervention. The study is powered adequately so that this aim can be tested separately for head and neck cancer and stroke patients. Our primary outcome measure is return to oral feeding, i.e., 100% of nutrition and hydration by mouth.

Condition	Intervention
Deglutition Disorders	Procedure: Shaker Exercise vs. Traditional Dysphagia Therapy Regime

MedlinePlus related topics:

Exercise and Physical Fitness Swallowing Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Efficacy Study

Official Title:	Comparison of Two Therapies for UES Dysphagia

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:	204
Study Completion Date:	December 2007

Detailed Description:

Secondary aims of this research are:

Determine in a descriptive manner whether patients with residue in the pyriform sinuses who aspirate the residue after the swallow respond better, i.e., a higher percentage of them can return to 100% oral intake, than patients with residue in the valleculae who aspirate after the swallow or patients with residue in both locations who aspirate after the swallow and thus to define the spectrum of indications for the proposed exercise programs in the two groups of dysphagic patients (stroke and post-chemo radiation treatment for head and neck cancer) and whether postures enable each patient type to swallow more bolus types without aspiration at pre- and post
Define the pathophysiology underlying the swallow dysfunction and those pathophysiologic elements which change as a result of each therapy program including changes in -
1. anteroposterior and lateral diameter of maximum deglutitive UES opening
2. maximum deglutitive laryngeal anterior and superior excursions

Eligibility

Ages Eligible for Study:	21 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria (all required)

Patients with pharyngeal phase dysphagia due to stroke or chemoradiation for head and neck cancer (without surgical intervention)
Incomplete UES opening and post-deglutitive aspiration
Hypopharyngeal (pyriform sinus) residue or vallecular residue alone or in combination
Dysphagia requiring tube feeding (at least 3 months non-oral condition)
Able to comply with protocol mandates, willing to perform the exercise programs, and ability to attend study sessions.

Exclusion Criteria

Pharyngeal surgical procedures
Other neuromuscular disorders such as
Lack of cognition
Metabolic myopathies
History of alcoholic neuropathy
Steroid myopathy
Cervical spine injury, lesions, or large osteophytes
Kerns-Sayers Syndrome
Individuals unable to exercise independently
Oculo-pharyngeal and other dystrophies
Current use of anticholinergics:

bensodiazopin, antihistamines

Myasthenia gravis
Elimination of aspiration with posture during VFG
Absent pharyngeal swallow on VFG
Aspiration before or during the swallow (pre and intradeglutitive aspiration)
Not completely tube feeding dependent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059670

Locations


United States, Wisconsin
	Medical College University of Wisconsin
	Milwaukee, Wisconsin, United States

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators


Principal Investigator:	Reza Shaker, M.D.	Professor and Chief, Division of Gastroenterology and Hepatology, Director, Digestive Disease Center, Medical College of Wisconsin

Principal Investigator:	Jerilyn A. Logemann, Ph.D.	Professor Department of Communication Sciences and Disorders, Ralph and Jean Sundin Professor of Communication Sciences and Disorders, Northwestern University

More Information

Division of Gastroenterology and Hepatology This link exits the ClinicalTrials.gov site

Publications:

Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21.

Study ID Numbers:	UESD
First Received:	May 1, 2003
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00059670
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

UES

Dysphagia

Study placed in the following topic categories:

Deglutition Disorders

Otorhinolaryngologic Diseases

Digestive System Diseases

Esophageal disorder

Gastrointestinal Diseases

Esophageal Diseases

Pharyngeal Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00059670