Clinical trial NCT00722111: Exercise for Swallowing Problems After Stroke
Official title: Rehabilitation Exercise for Dysphagia Subsequent to Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Deglutition Disorders
Keywords: tongue
pressure
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Wisconsin, Madison
First posted: 2008-07-25
Enrollment: 83
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Isometric Lingual Pressure
timeFrame: 8 weeks
measure: Maximum Isometric Tongue Pressure
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Wlliam S. Middleton Memorial Veterans Hospital, Madison
state: Wisconsin
Study officials:
affiliation: Wlliam S. Middleton Memorial Veterans Hospital, Madison
name: JoAnne Robbins, PhD
role: PRINCIPAL_INVESTIGATOR
References: