Effects of Age and Age-Related Diseases on Swallowing

Dysphagia Clinical Trial

Official title: Effects of Age and Age-Related Diseases on Swallowing

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysphagia

• NCT number: NCT00038350
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: Phase 2
• Start date: January 2002
• Completion date: March 2006