Cough and Swallow Rehab Following Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Florida
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01907321
First received: July 11, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

Stroke is the leading case of neurologic swallow dysfunction, or dysphagia. Post stroke dysphagia is associated with approximately 50% increase in the rate of pneumonia diagnoses; aspiration pneumonia is the most common respiratory complication in all stroke deaths, accounting for a three-fold increase in the 30-day post stroke death rate. The long-term goal of this systematic line of research is to decrease the morbidity, mortality, and health care costs associated with disordered airway protection following stroke.

The overall hypothesis central to this proposal is that the ability to protect the airway is dependent upon a continuum of multiple behaviors, including swallowing and cough. Safe, efficient swallowing prevents material from entering the larynx and lower airway, and effective cough ejects aspirate or mucus material. Currently, only one end of the continuum, swallowing, is rigorously assessed in stroke patients. However, ineffective or disordered cough is indicative of the inability to eject aspirate material or clear mucus and secretions from the lower airway. Ineffective clearance and subsequent accumulation of material in the lower airway increases the risk of chest infection. Hence, patients at the greatest risk for chest infection would not only have disordered swallowing (dysphagia) but also disordered cough (dystussia), meaning they are more likely to aspirate material and then cannot effectively eject the aspirate from the airway. There is a high likelihood that swallowing and cough are simultaneously disordered following stroke. To date, there is a treatment that targets both swallowing and cough function in stroke patients.

Expiratory muscle strength training (EMST) increases expiratory muscle strength (Baker et al., 2005) and there is evidence that supports its use to improve both swallow and cough functions in patients with Parkinson's disease (Troche et al., in press). This cross-system, device-driven approach to rehabilitating multiple contributors to airway protection deficits is highly desirable in the stroke population due to the likelihood of the co-occurrence of both swallow and cough disorders. To date, EMST has not been tested in stroke patients. We propose that by including cough in the screening, evaluation and treatment processes for disorders of airway protection, we will be able to better identify and treat patients most at risk for airway compromise and associated sequelae.


Condition Intervention Phase
Ischemic Stroke
Behavioral: Expiratory muscle strength training
Behavioral: Placebo expiratory training
Drug: Measures perfomed on all subjects
Behavioral: Pulmonary function test
Radiation: Fluoroscopic swallow study
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cough and Swallow Rehabilitation Following Stroke

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Maximum Expiratory Pressure [ Time Frame: Change in baseline to week 7 ] [ Designated as safety issue: No ]
    This measure will indicate if there are strength gains in the respiratory muscle by measuring expiratory pressure generating ability.


Secondary Outcome Measures:
  • Cough expiratory airflow [ Time Frame: Change in baseline to 7 weeks ] [ Designated as safety issue: No ]
    Cough airflow measure of peak expiratory flow rate


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Expiratory muscle strength training (EMST)
Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.
Behavioral: Expiratory muscle strength training
Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure. Once sufficient pressure is achieved (participant blowing out into the device) a valve is released, letting air flow through.
Other Name: EMST
Drug: Measures perfomed on all subjects
Capsaicin is a cough-inducing vapor that will be inhaled by participants to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, peak expiratory flow rate, and post-peak plateau phase will be made.
Other Name: Capsaicin
Behavioral: Pulmonary function test
Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Also included is the measure of maximum expiratory pressure. Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.
Other Name: Spirometry
Radiation: Fluoroscopic swallow study
Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA).
Other Name: Modified barium swallow study
Placebo Comparator: Placebo expiratory training
Same look and feel of EMST with no resistance. Same protocol - 5 repetitions of 5 sets, 5 days per week
Behavioral: Placebo expiratory training
Device with the same look and feel as the active EMST, but which provides no resistance to airflow.
Drug: Measures perfomed on all subjects
Capsaicin is a cough-inducing vapor that will be inhaled by participants to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, peak expiratory flow rate, and post-peak plateau phase will be made.
Other Name: Capsaicin
Behavioral: Pulmonary function test
Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Also included is the measure of maximum expiratory pressure. Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.
Other Name: Spirometry
Radiation: Fluoroscopic swallow study
Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA).
Other Name: Modified barium swallow study

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute (0-14 days) and subacute (14 days - 6 months) ischemic stroke
  2. Neurologic status permits participation.
  3. Medical status permits participation.

Exclusion Criteria:

  1. Dysphagia secondary to something other than stroke.
  2. Refuses consent.
  3. Incapable of informed consent and has no representative.
  4. Multiple strokes and previous history of dysphagia secondary to stroke.
  5. Longer than 6 months post-stroke
  6. Known cardiac valve thrombosis
  7. Stroke etiology of dissection
  8. Unstable / evolving stroke lesion.
  9. History of cancer in the head or neck
  10. History of radiation to the head or neck
  11. History of degenerative disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907321

Contacts
Contact: Karen W Hegland, PhD 352 373-3710 kwheeler@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Karen W Hegland, PHD    325-273-3805    kwheeler@ufl.edu   
Principal Investigator: Karen W Hegland, PhD         
Brooks Rehabilitation Clinical Research Center Recruiting
Jacksonville, Florida, United States, 32216
Contact: Floris F Singletary, MS CCC-SLP    904-345-8973    flo.singletary@brooksrehab.org   
Contact: Holly Morris, MSN,RN    904 345 7302    holly.morris@brooksrehab.org   
Sub-Investigator: Floris F Singletary, MS CCC-SLP         
Sponsors and Collaborators
University of Florida
American Heart Association
Investigators
Principal Investigator: Karen W Hegland, PHD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01907321     History of Changes
Other Study ID Numbers: 20-2011
Study First Received: July 11, 2013
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Florida:
stroke
dysphagia
dystussia
cough
maximum expiratory pressure

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014