Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038350
Status:
COMPLETED
Last Update Posted:
2008-05-06
First Post:
2002-05-30
Brief Title:
Effects of Age and Age-Related Diseases on Swallowing
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effects of Age and Age-Related Diseases on Swallowing
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None