Cerebrovascular AccidentNCT00722111
Exercise for Swallowing Problems After Stroke
A study testing lingual press, effortful swallowing and natural swallowing in people with Cerebrovascular Accident and Deglutition Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to determine whether stroke patients with swallowing problems will show greater swallowing improvement with intense oral exercise than subjects who perform either a low intensity oral exercise or a sham exercise. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cerebrovascular Accident, Deglutition Disorders
- What is being tested?
- lingual press, effortful swallowing and natural swallowing
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3 months post ischemic or hemorrhagic stroke
- 45 years of age or older
- physician approval of medical stability
- aspiration or penetration of the laryngeal vestibule (score of 3 or higher on Penetration/Aspiration Scale) or post swallow residue in the oropharynx
- able to manage own secretions with no signs of aspiration
- the capacity to provide informed consent
Who cannot join
- neurologic insult (other than stroke) or neuromuscular disease
- history of radiation to the head or neck
- poorly controlled psychosis
- lack the capacity to complete the exercise program
- refractory alcoholism (on AWD precautions)
- class IV congestive heart failure
Show all 17Show fewer
- sever chronic obstructive pulmonary disease (home oxygen dependent)
- end-stage renal failure
- allergy to barium (used in radiographic swallowing assessment
- Subjects with known contraindication will be excluded from the MRI portion of the protocol:
- Cardiac pacemakers
- Aneurysm clips
- Neurostimulators
- Cochlear implant
- Ossicular prostheses
- Intracranial or intraorbital foreign bodies
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705
About this study
Official title: Rehabilitation Exercise for Dysphagia Subsequent to Stroke
The purpose of this study is to determine whether stroke patients with swallowing problems will show greater swallowing improvement with intense oral exercise than subjects who perform either a low intensity oral exercise or a sham exercise.
Read the detailed description
Swallowing problems affect as many as 40% of adults over age 60. Serious consequences are suffered by the numerous patients with neuromuscular deficits secondary to stroke. Patients with dysphagia subsequent to stroke face risk of death from pneumonia, perhaps the most serious sequelae of dysphagia, with malnutrition and dehydration also dire secondary consequences. If stroke patients survive, they require longer hospital stays and nursing home placements with diminished rehabilitation potential. Despite these devastating influences that dysphagia secondary to stroke has on health, evidence supporting the effects of specific interventions on swallowing outcomes in this population is sparse.
Neural plasticity is the mechanism by which the damaged brain relearns "lost behavior" in response to rehabilitation. A goal of this proposal is to implement several principles of exercise and neural plasticity (specificity, repetition, and intensity) in a clinically justifiable manner so they may be used to guide clinical research and ultimately practice. To that end, we will determine how neuromuscular changes affect swallowing outcomes in response to 3 unique 8-week exercise interventions compared with a sham hand (control) exercise group.
The main hypothesis is that after 8 weeks of intense progressive rehabilitation exercise with feedback - lingual press (high-intensity, oral, non-swallowing) stroke patients with dysphagia will show swallowing improvement (defined as an improved score on the Penetration/Aspiration Scale and/or the Residue Scale in the absence of worsening in the other average score) to a greater extent than subjects who perform natural swallowing (low-intensity swallowing) exercises or the sham (control) exercise group. This hypothesis will be tested by 3 discrete objectives: Objective 1: Compare outcomes of four different 8-week exercise interventions among dysphagic stroke patients; Objective 2: Characterize bolus flow, swallowing biomechanics, lingual anatomy and swallowing function of stroke patients through initial calculation of multi-dimensional swallowing profiles pre-intervention and comparison of these profiles post-intervention; and Objective 3: Determine the most appropriate dose of treatment between 4 and 8 weeks for study subjects.
We will randomize 200 men and women post-stroke into four groups (50 subjects per group). Subjects will be randomized into one of four groups, to identify treatment outcomes. The exercise interventions include (a) lingual press (high-intensity, oral, non-swallowing) (b) effortful swallowing (high-intensity swallowing); and (c) natural swallowing (low intensity swallowing), compared with (d) a non-oral sham (control) exercise. All exercises will involve 2 sets of 10 repetitions performed 3 times a day on 3 non-consecutive days per week.
For Objectives 1 and 2 at baseline, week 4, and week 8, each subject will complete simultaneous videofluoroscopic and lingual pressure measures to calculate measures of bolus flow and swallowing biomechanics, which comprise 1) direction (average Penetration/Aspiration Scale Score), completeness (average Residue Scale Score), and duration in msec; 2) isometric and swallowing pressures; and 3) duration and extent of hyolaryngeal excursion and opening of the upper esophageal sphincter. At each of the 3 timepoints, each subject also will complete magnetic resonance imaging (MRI) to measure stroke lesion volume, lingual volume, and lingual tissue differentiation as well as complete swallowing-specific quality of life and dietary questionnaires. For Objective 3, subjects will complete all measures at baseline and weeks 4 and 8 to determine when the most benefits are made during the course of exercise. Knowledge of the dose response will allow for more accurate prescription of the clinical programs.
The Dept. of Veterans Affairs has designated "aging" and its impact on health as high research priorities. As the aging veteran population grows, dysphagia and its deleterious health consequences including pneumonia and/or malnutrition will be an increasing public health burden. In fact, VHA Directive 2006-32 was recently issued (May 17, 2006) defining standard procedures for assessment and treatment of patients with dysphagia. Appropriate diagnosis and treatment for dysphagia with low-cost, non-invasive efficacious exercise programs may not only reduce health care costs, but also will lead to improvements in patient health and quality of life. For patients post-stroke, the implications are enormous when the life-threatening incidence of aspiration is reduced or prevented.
- Conditions
- Cerebrovascular Accident, Deglutition Disorders
- Being tested
- lingual press, effortful swallowing, natural swallowing, non-oral sham (control) exercise
- Keywords
- tongue, pressure
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lingual pressDevice
lingual press (high-intensity, oral, non-swallowing)
effortful swallowingBehavioural
effortful swallowing (high-intensity swallowing)
natural swallowingBehavioural
natural swallowing (high frequency, low intensity swallowing)
non-oral sham (control) exerciseBehavioural
non-oral sham (control) exercise
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | lingual press (high-intensity, oral, non-swallowing) Receives: Device: lingual press |
| Arm 2 | Experimental | effortful swallowing (high-intensity swallowing) Receives: Behavioral: effortful swallowing |
| Arm 3 | Experimental | natural swallowing (high frequency, low intensity swallowing) Receives: Behavioral: natural swallowing |
| Arm 4 | Sham comparator | non-oral sham (control) exercise Receives: Behavioral: non-oral sham (control) exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Lingual Pressure
Tongue Strength
Measured: 8 weeks
Maximum Isometric Tongue Pressure
Peak isometric pressure at 4 sensors
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- JoAnne Robbins, PhD, Principal investigator, Wlliam S. Middleton Memorial Veterans Hospital, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722111
- Sponsor's protocol ID
- C4796-R
- Status last verified
- Mar 2018
- First submitted
- 23 Jul 2008
- Last updated
- 21 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Exercise for Dysphagia Subsequent to Stroke
- ClinicalTrials.gov ID
- NCT00722111
- Acronym / sponsor ID
- C4796-R
- Conditions
- Cerebrovascular Accident, Deglutition Disorders
- Keywords
- tongue, pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Wisconsin, Madison
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Jul 2008 (estimated)
- Results
- Posted 21 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether stroke patients with swallowing problems will show greater swallowing improvement with intense oral exercise than subjects who perform either a low intensity oral exercise or a sham exercise.
Detailed description
Swallowing problems affect as many as 40% of adults over age 60. Serious consequences are suffered by the numerous patients with neuromuscular deficits secondary to stroke. Patients with dysphagia subsequent to stroke face risk of death from pneumonia, perhaps the most serious sequelae of dysphagia, with malnutrition and dehydration also dire secondary consequences. If stroke patients survive, they require longer hospital stays and nursing home placements with diminished rehabilitation potential. Despite these devastating influences that dysphagia secondary to stroke has on health, evidence supporting the effects of specific interventions on swallowing outcomes in this population is sparse.
Neural plasticity is the mechanism by which the damaged brain relearns "lost behavior" in response to rehabilitation. A goal of this proposal is to implement several principles of exercise and neural plasticity (specificity, repetition, and intensity) in a clinically justifiable manner so they may be used to guide clinical research and ultimately practice. To that end, we will determine how neuromuscular changes affect swallowing outcomes in response to 3 unique 8-week exercise interventions compared with a sham hand (control) exercise group.
The main hypothesis is that after 8 weeks of intense progressive rehabilitation exercise with feedback - lingual press (high-intensity, oral, non-swallowing) stroke patients with dysphagia will show swallowing improvement (defined as an improved score on the Penetration/Aspiration Scale and/or the Residue Scale in the absence of worsening in the other average score) to a greater extent than subjects who perform natural swallowing (low-intensity swallowing) exercises or the sham (control) exercise group. This hypothesis will be tested by 3 discrete objectives: Objective 1: Compare outcomes of four different 8-week exercise interventions among dysphagic stroke patients; Objective 2: Characterize bolus flow, swallowing biomechanics, lingual anatomy and swallowing function of stroke patients through initial calculation of multi-dimensional swallowing profiles pre-intervention and comparison of these profiles post-intervention; and Objective 3: Determine the most appropriate dose of treatment between 4 and 8 weeks for study subjects.
We will randomize 200 men and women post-stroke into four groups (50 subjects per group). Subjects will be randomized into one of four groups, to identify treatment outcomes. The exercise interventions include (a) lingual press (high-intensity, oral, non-swallowing) (b) effortful swallowing (high-intensity swallowing); and (c) natural swallowing (low intensity swallowing), compared with (d) a non-oral sham (control) exercise. All exercises will involve 2 sets of 10 repetitions performed 3 times a day on 3 non-consecutive days per week.
For Objectives 1 and 2 at baseline, week 4, and week 8, each subject will complete simultaneous videofluoroscopic and lingual pressure measures to calculate measures of bolus flow and swallowing biomechanics, which comprise 1) direction (average Penetration/Aspiration Scale Score), completeness (average Residue Scale Score), and duration in msec; 2) isometric and swallowing pressures; and 3) duration and extent of hyolaryngeal excursion and opening of the upper esophageal sphincter. At each of the 3 timepoints, each subject also will complete magnetic resonance imaging (MRI) to measure stroke lesion volume, lingual volume, and lingual tissue differentiation as well as complete swallowing-specific quality of life and dietary questionnaires. For Objective 3, subjects will complete all measures at baseline and weeks 4 and 8 to determine when the most benefits are made during the course of exercise. Knowledge of the dose response will allow for more accurate prescription of the clinical programs.
The Dept. of Veterans Affairs has designated "aging" and its impact on health as high research priorities. As the aging veteran population grows, dysphagia and its deleterious health consequences including pneumonia and/or malnutrition will be an increasing public health burden. In fact, VHA Directive 2006-32 was recently issued (May 17, 2006) defining standard procedures for assessment and treatment of patients with dysphagia. Appropriate diagnosis and treatment for dysphagia with low-cost, non-invasive efficacious exercise programs may not only reduce health care costs, but also will lead to improvements in patient health and quality of life. For patients post-stroke, the implications are enormous when the life-threatening incidence of aspiration is reduced or prevented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: lingual presslingual press (high-intensity, oral, non-swallowing) |
| Arm 2 | Experimental | Behavioral: effortful swallowingeffortful swallowing (high-intensity swallowing) |
| Arm 3 | Experimental | Behavioral: natural swallowingnatural swallowing (high frequency, low intensity swallowing) |
| Arm 4 | Sham comparator | Behavioral: non-oral sham (control) exercisenon-oral sham (control) exercise |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 3 months post ischemic or hemorrhagic stroke
- 45 years of age or older
- physician approval of medical stability
- aspiration or penetration of the laryngeal vestibule (score of 3 or higher on Penetration/Aspiration Scale) or post swallow residue in the oropharynx
- able to manage own secretions with no signs of aspiration
Key exclusion criteria (17 listed)
- neurologic insult (other than stroke) or neuromuscular disease
- history of radiation to the head or neck
- poorly controlled psychosis
- lack the capacity to complete the exercise program
- refractory alcoholism (on AWD precautions)
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 |
|---|---|---|
| lingual presslingual press (high-intensity, oral, non-swallowing) | Device | Arm 1 |
| effortful swallowingeffortful swallowing (high-intensity swallowing) | Behavioural | Arm 2 |
| natural swallowingnatural swallowing (high frequency, low intensity swallowing) | Behavioural | Arm 3 |
| non-oral sham (control) exercisenon-oral sham (control) exercise | Behavioural | Arm 4 |
Primary outcome
Isometric Lingual Pressure
Time frame: 8 weeks
Tongue Strength
Maximum Isometric Tongue Pressure
Time frame: 16 months
Peak isometric pressure at 4 sensors
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Wlliam S. Middleton Memorial Veterans Hospital, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lingual press, effortful swallowing and natural swallowing in people with Cerebrovascular Accident and Deglutition Disorders, run by VA Office of Research and Development 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 6 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 21 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Isometric Lingual Pressure (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 21 Mar 2018.