Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00059670
First received: May 1, 2003
Last updated: January 12, 2010
Last verified: January 2010

May 1, 2003
January 12, 2010
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Complete list of historical versions of study NCT00059670 on ClinicalTrials.gov Archive Site
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Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia
Comparison of Two Therapies for UES Dysphagia

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.

Secondary aims of this research are:

  1. 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
  2. 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
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Deglutition Disorders
Procedure: Shaker Exercise vs. Traditional Dysphagia Therapy Regime
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
December 2007
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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
Both
21 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00059670
UESD (completed)
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP