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Home > "E" Clinical Trials Conditions > Effects of Age and Age-Related Diseases on Swallowing  Effects of Age and Age-Related Diseases on Swallowing
Effects of Age and Age-Related Diseases on Swallowing
For Condition: Dysphagia
Status: Recruiting
Sponsor(s): Department of Veterans Affairs Rehabilitation Research and Development Service ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry Criteria: Swallowing diseases
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
DavidWolff, , Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service
VA Medical Center *Recruiting*
Madison, Wisconsin,
United States
Recruiting JoAnne Robbins 608-280-7000
Additional Information:
Study ID Numbers: E2641;
Study Start Date: January 2002
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038350
Other Dysphagia Studies:
1. Effects of Age and Age-Related Diseases on Swallowing
2. Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients with Dysphagia
Related Studies:
Other Dysphagia Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Effects of Age and Age-Related Diseases on Swallowing
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