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Effects of Age and Age-Related Diseases on Swallowing

Primary Purpose

Dysphagia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lingual Strengthening
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring Age, Dysphagia, Swallowing

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Wlliam S. Middleton Memorial Veterans Hospital, Madison

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

8 week lingual strengthening exercise protocol

Outcomes

Primary Outcome Measures

Oropharyngeal physiology including lingual pressure and measures of bolus flow

Secondary Outcome Measures

Full Information

First Posted
May 30, 2002
Last Updated
May 5, 2008
Sponsor
US Department of Veterans Affairs
Collaborators
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00038350
Brief Title
Effects of Age and Age-Related Diseases on Swallowing
Official Title
Effects of Age and Age-Related Diseases on Swallowing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs
Collaborators
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Age, Dysphagia, Swallowing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
8 week lingual strengthening exercise protocol
Intervention Type
Behavioral
Intervention Name(s)
Lingual Strengthening
Intervention Description
8 week lingual strengthening exercise protocol
Primary Outcome Measure Information:
Title
Oropharyngeal physiology including lingual pressure and measures of bolus flow
Time Frame
8 week protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Robbins, PhD
Organizational Affiliation
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wlliam S. Middleton Memorial Veterans Hospital, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17602265
Citation
Hewitt A, Hind J, Kays S, Nicosia M, Doyle J, Tompkins W, Gangnon R, Robbins J. Standardized instrument for lingual pressure measurement. Dysphagia. 2008 Mar;23(1):16-25. doi: 10.1007/s00455-007-9089-0.
Results Reference
result
PubMed Identifier
17270511
Citation
Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8. doi: 10.1016/j.apmr.2006.11.002.
Results Reference
result
PubMed Identifier
16137276
Citation
Robbins J, Gangnon RE, Theis SM, Kays SA, Hewitt AL, Hind JA. The effects of lingual exercise on swallowing in older adults. J Am Geriatr Soc. 2005 Sep;53(9):1483-9. doi: 10.1111/j.1532-5415.2005.53467.x.
Results Reference
result

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Effects of Age and Age-Related Diseases on Swallowing

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