Effects of Age and Age-Related Diseases on Swallowing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038350
Recruitment Status : Completed
First Posted : May 31, 2002
Last Update Posted : May 6, 2008
University of Wisconsin, Madison
Information provided by:
VA Office of Research and Development

Brief Summary:
The long-term goal of this research program is to advance the treatment of swallowing disorders in elderly adults. This study will identify the impact of an 8-week progressive resistance exercise program for oral muscles on swallowing physiology, anatomy, dietary intake, and Quality of Life (QOL) in frail dysphagic adults. Findings from the exercise program may indicate new directions for treatments and techniques designed to influence the biological underpinnings of dysphagia in elderly persons. Translation of these findings into clinical practice will have far-reaching significance in the fields of gerontology, speech language pathology, and long-term care.

Condition or disease Intervention/treatment Phase
Dysphagia Behavioral: Lingual Strengthening Phase 2

Detailed Description:

The overall goal of the proposed research is to evaluate the effects of lingual resistance exercise on swallowing and related outcomes in frail elderly patients with dysphagia. In addition, we will determine if there are prognostic factors that will allow us to predict for whom the intervention is most effective. For all objectives, frail, dysphagic patients will be randomized into 2 treatment groups: a) standard swallowing treatment and an 8-week tongue exercise program, or b) standard swallowing treatment and an 8-week hand exercise program, which serves as a "sham" intervention.

Objective 1: To quantify the effects of the exercise program on bolus flow which are: a) direction as measured by the Penetration Aspiration Scale; b) completeness (residual rating scale 7) and; c) duration in msec.

Objective 2: To quantify the effects of the exercise program on oropharyngeal physiology including lingual pressure (a surrogate for strength) and kinematics of the hyolaryngeal complex and opening of the upper esophageal sphincter (UES) and to determine the contributions of these measures to bolus flow and functional outcomes including swallowing-specific quality of life and dietary intake.

Objective 3: To quantify the underlying changes in lingual volume and tissue composition resulting from participation in the exercise program.

Objective 4: To determine the effect of an 8-week lingual resistance exercise program on swallowing function, as quantified by a valid, reliable measure of swallowing-related quality of life (QOL) and dietary intake.

Objective 5: To explore the time course of the response by examining outcomes after 4 and after 8 weeks of exercise.

All objectives will be pursued in parallel across the 3 years of research. Milestones for accomplishing these objectives include: (1) Year 1: implementing procedures, manuals, and instrumentation for strength testing and training by Month 4; enrolling 24 subjects by Month 12; (2) Year 2: enrolling 40 subjects by Month 24 and writing a preliminary manuscript; (3) Year 3: completing subject enrollment by Month 30, which requires 16 additional subjects, completing statistical analyses regarding intervention effects by Month 34, and completing 2 comprehensive reports on results by Month 36.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Age and Age-Related Diseases on Swallowing
Study Start Date : January 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
8 week lingual strengthening exercise protocol
Behavioral: Lingual Strengthening
8 week lingual strengthening exercise protocol

Primary Outcome Measures :
  1. Oropharyngeal physiology including lingual pressure and measures of bolus flow [ Time Frame: 8 week protocol ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Age of 65 or older, MD determined medical stability, referred by MD for swallowing evaluation because of suspected dysphagia, confirmed dysphagia by x-ray evaluation, geographic access to return for clinic appointments, telephone in home, ability to perform exercises, capacity to provide informed consent, frailty defined by Winograd et al

Exclusion Criteria:

Admitted from a nursing home after a longer than 3 month stay, previously enrolled in this study, not able or willing to return for outpatient visits, unable to complete telephone interviews, cerebrovascular accident within 90 days, medically unstable as determined by MD, claustrophobia, known contraindications to MR imaging (e.g., pacemaker, aneurysm clip), more than 2 dental crowns, poorly controlled psychosis, refractory alcoholism, other severe disabling diseases resistant to medical management (e.g., class IV congestive heart failure, end stage renal disease), allergy to barium, terminally ill (predicted survival less than 6 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038350

United States, Wisconsin
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
VA Office of Research and Development
University of Wisconsin, Madison
Principal Investigator: Joanne Robbins, PhD Wlliam S. Middleton Memorial Veterans Hospital, Madison

Publications of Results:
Responsible Party: Robbins, Joanne - Principal Investigator, Department of Veterans Affairs Identifier: NCT00038350     History of Changes
Other Study ID Numbers: E2641R
First Posted: May 31, 2002    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: May 2008

Keywords provided by VA Office of Research and Development:

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases