Deglutition DisordersNCT00059670
Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia
A study testing Shaker Exercise vs. Traditional Dysphagia Therapy Regime in people with Deglutition Disorders, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The aim of this research study is to determine the effectiveness of: 1) a traditional therapy regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box) musculature and 2) a new therapeutic exercise, the Shaker exercise. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- Shaker Exercise vs. Traditional Dysphagia Therapy Regime
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pharyngeal phase dysphagia due to stroke or chemoradiation for head and neck cancer (without surgical intervention)
- Incomplete UES opening and post-deglutitive aspiration
- Hypopharyngeal (pyriform sinus) residue or vallecular residue alone or in combination
- Dysphagia requiring tube feeding (at least 3 months non-oral condition)
- Able to comply with protocol mandates, willing to perform the exercise programs, and ability to attend study sessions.
Who cannot join
- Pharyngeal surgical procedures
- Other neuromuscular disorders such as
- Lack of cognition
- Metabolic myopathies
- History of alcoholic neuropathy
- Steroid myopathy
Show all 17Show fewer
- Cervical spine injury, lesions, or large osteophytes
- Kerns-Sayers Syndrome
- Individuals unable to exercise independently
- Oculo-pharyngeal and other dystrophies
- Current use of anticholinergics:
- bensodiazopin, antihistamines
- Myasthenia gravis
- Elimination of aspiration with posture during VFG
- Absent pharyngeal swallow on VFG
- Aspiration before or during the swallow (pre and intradeglutitive aspiration)
- Not completely tube feeding dependent
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College University of Wisconsin
Milwaukee, Wisconsin
About this study
Official title: Comparison of Two Therapies for UES Dysphagia
The aim of this research study is to determine the effectiveness of: 1) a traditional therapy regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box) musculature and 2) a new therapeutic exercise, the Shaker exercise.
The primary objective of this 5-year project is to identify which of two therapy programs, the Shaker exercise versus traditional therapy, results in the largest number of stable, non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6 weeks of intervention. The study is powered adequately so that this aim can be tested separately for head and neck cancer and stroke patients. Our primary outcome measure is return to oral feeding, i.e., 100% of nutrition and hydration by mouth.
Read the detailed description
Secondary aims of this research are:
- Determine in a descriptive manner whether patients with residue in the pyriform sinuses who aspirate the residue after the swallow respond better, i.e., a higher percentage of them can return to 100% oral intake, than patients with residue in the valleculae who aspirate after the swallow or patients with residue in both locations who aspirate after the swallow and thus to define the spectrum of indications for the proposed exercise programs in the two groups of dysphagic patients (stroke and post-chemo radiation treatment for head and neck cancer) and whether postures enable each patient type to swallow more bolus types without aspiration at pre- and post
- Define the pathophysiology underlying the swallow dysfunction and those pathophysiologic elements which change as a result of each therapy program including changes in -
- anteroposterior and lateral diameter of maximum deglutitive UES opening
- maximum deglutitive laryngeal anterior and superior excursions
- Conditions
- Deglutition Disorders
- Being tested
- Shaker Exercise vs. Traditional Dysphagia Therapy Regime
- Keywords
- UES, Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shaker Exercise vs. Traditional Dysphagia Therapy RegimeProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2003 (estimated)
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 204 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Reza Shaker, M.D., Principal investigator, Professor and Chief, Division of Gastroenterology and Hepatology, Director, Digestive Disease Center, Medical College of WisconsinJerilyn A. Logemann, Ph.D., Principal investigator, Professor Department of Communication Sciences and Disorders, Ralph and Jean Sundin Professor of Communication Sciences and Disorders, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059670
- Sponsor's protocol ID
- UESD (completed)
- Status last verified
- Jan 2010
- First submitted
- 1 May 2003
- Last updated
- 13 Jan 2010
- Results posted
- No
Publications
Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21. doi: 10.1053/gast.2002.32999.
PubMed 11984518
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Therapies for UES Dysphagia
- ClinicalTrials.gov ID
- NCT00059670
- Acronym / sponsor ID
- UESD (completed)
- Conditions
- Deglutition Disorders
- Keywords
- UES, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study completion
- Dec 2007 (actual)
- First posted
- 2 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research study is to determine the effectiveness of: 1) a traditional therapy regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box) musculature and 2) a new therapeutic exercise, the Shaker exercise.
The primary objective of this 5-year project is to identify which of two therapy programs, the Shaker exercise versus traditional therapy, results in the largest number of stable, non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6 weeks of intervention. The study is powered adequately so that this aim can be tested separately for head and neck cancer and stroke patients. Our primary outcome measure is return to oral feeding, i.e., 100% of nutrition and hydration by mouth.
Detailed description
Secondary aims of this research are:
- Determine in a descriptive manner whether patients with residue in the pyriform sinuses who aspirate the residue after the swallow respond better, i.e., a higher percentage of them can return to 100% oral intake, than patients with residue in the valleculae who aspirate after the swallow or patients with residue in both locations who aspirate after the swallow and thus to define the spectrum of indications for the proposed exercise programs in the two groups of dysphagic patients (stroke and post-chemo radiation treatment for head and neck cancer) and whether postures enable each patient type to swallow more bolus types without aspiration at pre- and post
- Define the pathophysiology underlying the swallow dysfunction and those pathophysiologic elements which change as a result of each therapy program including changes in -
- anteroposterior and lateral diameter of maximum deglutitive UES opening
- maximum deglutitive laryngeal anterior and superior excursions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with pharyngeal phase dysphagia due to stroke or chemoradiation for head and neck cancer (without surgical intervention)
- Incomplete UES opening and post-deglutitive aspiration
- Hypopharyngeal (pyriform sinus) residue or vallecular residue alone or in combination
- Dysphagia requiring tube feeding (at least 3 months non-oral condition)
- Able to comply with protocol mandates, willing to perform the exercise programs, and ability to attend study sessions.
Key exclusion criteria (17 listed)
- Pharyngeal surgical procedures
- Other neuromuscular disorders such as
- Lack of cognition
- Metabolic myopathies
- History of alcoholic neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shaker Exercise vs. Traditional Dysphagia Therapy Regime | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 11984518Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21. doi: 10.1053/gast.2002.32999.
- Division of Gastroenterology and HepatologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Shaker, M.D. principal investigator
Professor and Chief, Division of Gastroenterology and Hepatology, Director, Digestive Disease Center, Medical College of Wisconsin
Jerilyn A. Logemann, Ph.D. principal investigator
Professor Department of Communication Sciences and Disorders, Ralph and Jean Sundin Professor of Communication Sciences and Disorders, Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shaker Exercise vs. Traditional Dysphagia Therapy Regime in people with Deglutition Disorders, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010; AzTrials last refreshed its copy on 8 Nov 2026.