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Cough and Swallow Rehab Following Stroke

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01907321
First received: July 11, 2013
Last updated: December 5, 2016
Last verified: October 2016
Results First Received: April 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Participant);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Interventions: Behavioral: Expiratory muscle strength training
Behavioral: Placebo expiratory training
Drug: Measures performed on all subjects
Behavioral: Pulmonary function test
Radiation: Fluoroscopic swallow study

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Participants were only recruited for the EMST group. There was not a control arm. There were several reasons, including concern regarding recruitment which was painfully slow for this study.

There is only 1 arm/group that completed the study.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
See above statement. There was only the EMST group/arm recruited for this study.

Reporting Groups
  Description
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.

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, enabling airflow.

Measures performed 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.

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.


Participant Flow:   Overall Study
    Expiratory Muscle Strength Training (EMST)
STARTED   14 
COMPLETED   12 
NOT COMPLETED   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Fourteen adults between the ages of 50 and 80 years, with a history of ischemic stroke within the previous 2 years.

Reporting Groups
  Description
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.

Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.

Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.

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). 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.

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).


Baseline Measures
   Expiratory Muscle Strength Training (EMST) 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Full Range)
 64.5 
 (52 to 77) 
Gender 
[Units: Participants]
Count of Participants
 
Female      6  42.9% 
Male      8  57.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      5  35.7% 
White      9  64.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   14 
Maximum expiratory pressure 
[Units: Centimeters of water (Cm H2O)]
Mean (Standard Deviation)
 71.2  (28.8) 
Pulmonary function (FEV1/FVC) 
[Units: Ratio (FEV1/FVC)]
Mean (Standard Deviation)
 .64  (.20) 
Penetration-aspiration score [1] 
[Units: Penetration-aspiration scale (1 is best)]
Median (Full Range)
 1 
 (1 to 8) 
[1] The Penetration-aspiration scale is an 8-point scale in which a score of 1 is best (material does not enter the airway) and a score of 8 is worst.


  Outcome Measures
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1.  Primary:   Maximum Expiratory Pressure   [ Time Frame: Change in baseline to week 7 ]

2.  Secondary:   Cough Expiratory Airflow   [ Time Frame: Change in baseline to 7 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Karen Hegland, PI
Organization: University of Florida
phone: 352 294-8366
e-mail: kwheeler@ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01907321     History of Changes
Other Study ID Numbers: 20-2011
Study First Received: July 11, 2013
Results First Received: April 18, 2016
Last Updated: December 5, 2016