NCT00038350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2002

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

May 6, 2008

Status Verified

May 1, 2008

Enrollment Period

4 years

First QC Date

May 30, 2002

Last Update Submit

May 5, 2008

Conditions

Dysphagia

Keywords

AgeDysphagiaSwallowing

Outcome Measures

Primary Outcomes (1)

  • Oropharyngeal physiology including lingual pressure and measures of bolus flow

    8 week protocol

Study Arms (1)

1

EXPERIMENTAL

8 week lingual strengthening exercise protocol

Behavioral: Lingual Strengthening

Interventions

Lingual StrengtheningBEHAVIORAL

8 week lingual strengthening exercise protocol

1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wlliam S. Middleton Memorial Veterans Hospital, Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

  • 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.

    PMID: 17602265RESULT

  • 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.

    PMID: 17270511RESULT

  • 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.

    PMID: 16137276RESULT

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Joanne Robbins, PhD

    Wlliam S. Middleton Memorial Veterans Hospital, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

May 30, 2002

First Posted

May 31, 2002

Study Start

January 1, 2002

Primary Completion

January 1, 2006

Study Completion

March 1, 2006

Last Updated

May 6, 2008

Record last verified: 2008-05

Locations

US(1)