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| Sponsors and Collaborators: |
Department of Veterans Affairs University of Wisconsin, Madison |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00038350 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Effects of Age and Age-Related Diseases on Swallowing |
| 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 |
|---|---|
|
1: Experimental
8 week lingual strengthening exercise protocol
|
Behavioral: Lingual Strengthening
8 week lingual strengthening exercise protocol
|
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 |
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| United States, Wisconsin | |
| Wlliam S. Middleton Memorial Veterans Hospital, Madison | |
| Madison, Wisconsin, United States, 53705 | |
| Principal Investigator: | Joanne Robbins, PhD | Wlliam S. Middleton Memorial Veterans Hospital, Madison |
More Information
| Responsible Party: | Department of Veterans Affairs ( Robbins, Joanne - Principal Investigator ) |
| Study ID Numbers: | E2641R |
| Study First Received: | May 30, 2002 |
| Last Updated: | May 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00038350 History of Changes |
| Health Authority: | United States: Federal Government |
|
Age Dysphagia Swallowing |
|
Deglutition Disorders Otorhinolaryngologic Diseases Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Esophageal Diseases Pharyngeal Diseases |
|
Deglutition Disorders Otorhinolaryngologic Diseases Digestive System Diseases |
Gastrointestinal Diseases Esophageal Diseases Pharyngeal Diseases |
