DysphagiaNCT01570023
Study of Tongue Strengthening for Swallowing Problems
A study testing Isometric Progressive Resistance Oropharyngeal Therapy in people with Dysphagia, run by University of Wisconsin, Madison at 9 sites in United States.
Trial summary
This study is a multisite, randomized clinical trial to determine the effectiveness of an 8-week rehabilitative exercise regime performed by patients with swallowing problems, termed dysphagia, compared to a control group of patients with swallowing problems who do not exercise, but receive standard clinical care. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Isometric Progressive Resistance Oropharyngeal Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2012to Sep 2015
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referral by a physician for swallowing evaluation because of suspected dysphagia
- complaint of difficulty swallowing
- aspiration or penetration of the laryngeal vestibule with liquids or semisolids OR post-swallow residue visible in the oral cavity, valleculae, or pharynx that is instrumentally documented by a participating SLP during a standard clinical videofluoroscopic swallowing study
- between the ages of 21 and 95
- ability to perform the exercise protocol independently or with the assistance of a caregiver
- physician approval of medical stability to participate
- decision-making capacity to provide informed consent (confirmed through discussion between the participating SLP and the subject's primary physician)
Who cannot join
- degenerative neuromuscular disease
- poorly controlled psychosis
- patient unable to complete the exercise program
- allergy to barium (used in videofluoroscopic swallowing assessment)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Silvercrest Center for Nursing and Rehabilitation
Briarwood, New York, 11435
Northwestern University
Evanston, Illinois, 60208
New York Hospital Queens
Flushing, New York, 11355
Central Baptist Hospital
Lexington, Kentucky, 40503
VA Medical Center-Memphis
Memphis, Tennessee, 38104
Minneapolis Veterans Administration Health Care System
Minneapolis, Minnesota, 55417
Beth Israel Medical Center
New York, New York, 10003
University of Pittsburgh Medical Center Passavant
Pittsburgh, Pennsylvania, 15237
University of Pittsburgh Medical Center Presbyterian University Hospital
Pittsburgh, Pennsylvania, 15237
About this study
Official title: Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia
This study is a multisite, randomized clinical trial to determine the effectiveness of an 8-week rehabilitative exercise regime performed by patients with swallowing problems, termed dysphagia, compared to a control group of patients with swallowing problems who do not exercise, but receive standard clinical care. One hundred male and female patients will take part in this study from eight participating facilities around the country.
- Conditions
- Dysphagia
- Being tested
- Isometric Progressive Resistance Oropharyngeal Therapy
- Keywords
- Deglutition, Exercise
- Medical subject headings
- Deglutition Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Progressive Resistance Oropharyngeal TherapyBehavioural
Tongue press exercises consist of pressing the tongue against the sensors. Isometric exercises will focus on the anterior and posterior sensor. Subjects will be given a target pressure value for both the anterior and posterior sensor locations for which to aim when doing the exercises. Visual feedback on the display will signal the subject that they have attained their target pressure goal.
| Study group | Role | What they receive |
|---|---|---|
| Standard Clinical Care | No intervention | Standard swallowing intervention is that which is identified by the SLP as appropriate to treat the patient's dysphagia and is in common clinical practice. Such treatment would consist of dietary or postural compensatory strategies (i.e., chin down posture while swallowing). |
| Standard Clinical Care Plus Isometric Lingual Exercise | Experimental | Standard Clinical Care Plus 8-week Isometric Lingual Exercise Regimen. The isometric tongue exercises will be completed using the Madison Oral Strengthening Therapeutic (MOST) device. Baseline maximum lingual pressure will be obtained at the anterior and posterior sensors independently by gathering two sets of data (3 MOST device trials) at each site (anterior and posterior) that differ by less that 5%. During week one of the regimen, the target value of each repetition will be 60% of the maximum baseline pressure. For the remaining seven weeks of the program, the target value will be increased to 80% of the maximum. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated. Receives: Behavioral: Isometric Progressive Resistance Oropharyngeal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Swallow Function
The Primary Outcome will be objectively measured from videofluoroscopic images. Improvement in swallowing is defined as a reduction in either the average Penetration/Aspiration scale score or the average Residue Scale score over the 11 swallows (3 3-ml thin liquid, 3 10-ml thin liquid, 3 3-ml semi-solid and 2 3-ml thin liquid effortful) combined with no increase in the other average score. If the series of swallows is terminated prematurely, the worst possible score (8 for Penetration/Aspiration Scale, 2 for residue) will be assigned for all uncompleted swallows.
Measured: Baseline and 8 Weeks
Secondary outcomes (5)
Change in Penetration/Aspiration Scale score
An 8-point scale indicating occurrence, depth, clearance and patient response to material invading the laryngeal vestibule or trachea. The Penetration/Aspiration Scale score will be objectively measured from videofluoroscopic images.
Measured: Baseline and Week 8
Change in Residue Scale score
A 3-point scale to measure post-swallow barium residue on a videofluoroscopic image. The Residue Scale score will be objectively measured from videofluoroscopic images.
Measured: Baseline and Week 8
Change in Bolus Transit Times
Durational measures of bolus flow through the oropharynx from videofluoroscopic images.
Measured: Baseline and 8 Weeks
Change in Isometric Lingual Pressure
Maximum tongue press measured using the FDA registered Madison Oral Strenthening Therapeutic (MOST) device.
Measured: Baseline and 8 Weeks
Change in Quality of Life
Each subject will complete a questionnaire detailing his/her quantity and variety of nutritional intake and also will complete a questionnaire (Swal-Qol) about the impact of dysphagia on his/her quality of life at baseline and week 8. It takes approximately 10 minutes to complete each questionnaire.
Measured: Baseline and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JoAnne Robbins, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570023
- Sponsor's protocol ID
- 2011-0518
- Status last verified
- Oct 2015
- First submitted
- 27 Mar 2012
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia
- ClinicalTrials.gov ID
- NCT01570023
- Acronym / sponsor ID
- 2011-0518
- Conditions
- Dysphagia
- Keywords
- Deglutition, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Apr 2012 (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.
This study is a multisite, randomized clinical trial to determine the effectiveness of an 8-week rehabilitative exercise regime performed by patients with swallowing problems, termed dysphagia, compared to a control group of patients with swallowing problems who do not exercise, but receive standard clinical care. One hundred male and female patients will take part in this study from eight participating facilities around the country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Clinical Care | No intervention | –Standard swallowing intervention is that which is identified by the SLP as appropriate to treat the patient's dysphagia and is in common clinical practice. Such treatment would consist of dietary or postural compensatory strategies (i.e., chin down posture while swallowing). |
| Standard Clinical Care Plus Isometric Lingual Exercise | Experimental | Behavioral: Isometric Progressive Resistance Oropharyngeal TherapyStandard Clinical Care Plus 8-week Isometric Lingual Exercise Regimen. The isometric tongue exercises will be completed using the Madison Oral Strengthening Therapeutic (MOST) device. Baseline maximum lingual pressure will be obtained at the anterior and posterior sensors independently by gathering two sets of data (3 MOST device trials) at each site (anterior and posterior) that differ by less that 5%. During week one of the regimen, the target value of each repetition will be 60% of the maximum baseline pressure. For the remaining seven weeks of the program, the target value will be increased to 80% of the maximum. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- referral by a physician for swallowing evaluation because of suspected dysphagia
- complaint of difficulty swallowing
- aspiration or penetration of the laryngeal vestibule with liquids or semisolids OR post-swallow residue visible in the oral cavity, valleculae, or pharynx that is instrumentally documented by a participating SLP during a standard clinical videofluoroscopic swallowing study
- between the ages of 21 and 95
- ability to perform the exercise protocol independently or with the assistance of a caregiver
Key exclusion criteria (4 listed)
- degenerative neuromuscular disease
- poorly controlled psychosis
- patient unable to complete the exercise program
- allergy to barium (used in videofluoroscopic swallowing assessment)
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 |
|---|---|---|
| Isometric Progressive Resistance Oropharyngeal TherapyTongue press exercises consist of pressing the tongue against the sensors. Isometric exercises will focus on the anterior and posterior sensor. Subjects will be given a target pressure value for both the anterior and posterior sensor locations for which to aim when doing the exercises. Visual feedback on the display will signal the subject that they have attained their target pressure goal. | Behavioural | Standard Clinical Care Plus Isometric Lingual Exercise |
Primary outcome
Change in Swallow Function
Time frame: Baseline and 8 Weeks
The Primary Outcome will be objectively measured from videofluoroscopic images. Improvement in swallowing is defined as a reduction in either the average Penetration/Aspiration scale score or the average Residue Scale score over the 11 swallows (3 3-ml thin liquid, 3 10-ml thin liquid, 3 3-ml semi-solid and 2 3-ml thin liquid effortful) combined with no increase in the other average score. If the series of swallows is terminated prematurely, the worst possible score (8 for Penetration/Aspiration Scale, 2 for residue) will be assigned for all uncompleted swallows.
5 secondary outcomes
Change in Penetration/Aspiration Scale score
Time frame: Baseline and Week 8
Change in Residue Scale score
Time frame: Baseline and Week 8
Change in Bolus Transit Times
Time frame: Baseline and 8 Weeks
Change in Isometric Lingual Pressure
Time frame: Baseline and 8 Weeks
Change in Quality of Life
Time frame: Baseline and 8 Weeks
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 12 Oct 2015.
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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.
JoAnne Robbins, PhD principal investigator
University of Wisconsin, Madison
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Progressive Resistance Oropharyngeal Therapy in people with Dysphagia, run by University of Wisconsin, Madison at 9 sites 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 7 inclusion and 4 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
What does the primary outcome measure?
Change in Swallow Function (time frame: Baseline and 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2015.