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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
lingual press, effortful swallowing and natural swallowing
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

Other trials in United States

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.

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 groups in NCT00722111
Study groupRoleWhat they receive
Arm 1Experimentallingual press (high-intensity, oral, non-swallowing)
Receives: Device: lingual press
Arm 2Experimentaleffortful swallowing (high-intensity swallowing)
Receives: Behavioral: effortful swallowing
Arm 3Experimentalnatural swallowing (high frequency, low intensity swallowing)
Receives: Behavioral: natural swallowing
Arm 4Sham comparatornon-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.

  1. Isometric Lingual Pressure

    Tongue Strength

    Measured: 8 weeks

  2. 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.

  1. First posted25 Jul 2008 (estimated)
  2. Study startFeb 2011
  3. Primary completionDec 2011
  4. Study completionJun 2012

Resources

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)
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
Data monitoring committee
No

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.

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