Effects of Age and Age-Related Diseases on Swallowing

This study has been completed.
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00038350
First received: May 30, 2002
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Dysphagia
Behavioral: Lingual Strengthening
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Age and Age-Related Diseases on Swallowing

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Oropharyngeal physiology including lingual pressure and measures of bolus flow [ Time Frame: 8 week protocol ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2002
Study Completion Date: March 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
8 week lingual strengthening exercise protocol
Behavioral: Lingual Strengthening
8 week lingual strengthening exercise protocol

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00038350

Locations
United States, Wisconsin
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Joanne Robbins, PhD Wlliam S. Middleton Memorial Veterans Hospital, Madison
  More Information

Publications:
Responsible Party: Robbins, Joanne - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00038350     History of Changes
Other Study ID Numbers: E2641R
Study First Received: May 30, 2002
Last Updated: May 5, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Age
Dysphagia
Swallowing

ClinicalTrials.gov processed this record on October 29, 2014