Trial Outcomes & Findings for Cough and Swallow Rehab Following Stroke (NCT NCT01907321)
NCT ID: NCT01907321
Last Updated: 2017-01-27
Results Overview
This measure will indicate if there are strength gains in the respiratory muscle by measuring expiratory pressure generating ability.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Change in baseline to week 7
Results posted on
2017-01-27
Participant Flow
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.
See above statement. There was only the EMST group/arm recruited for this study.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cough and Swallow Rehab Following Stroke
Baseline characteristics by cohort
| Measure |
Expiratory Muscle Strength Training (EMST)
n=14 Participants
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).
|
|---|---|
|
Age, Continuous
|
64.5 years
n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
|
Gender
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
Maximum expiratory pressure
|
71.2 centimeters of water (Cm H2O)
STANDARD_DEVIATION 28.8 • n=5 Participants
|
|
Pulmonary function (FEV1/FVC)
|
.64 ratio (FEV1/FVC)
STANDARD_DEVIATION .20 • n=5 Participants
|
|
Penetration-aspiration score
|
1 Penetration-aspiration scale (1 is best)
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in baseline to week 7Population: Data from 14 adults with a history of ischemic stroke was analyzed for changes in maximum expiratory pressure generating capacity, cough strength, and swallowing safety. All but 2 participants (1 male, 1 female) completed the protocol. Intent to treat analysis was used.
This measure will indicate if there are strength gains in the respiratory muscle by measuring expiratory pressure generating ability.
Outcome measures
| Measure |
Expiratory Muscle Strength Training (EMST)
n=14 Participants
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).
|
|---|---|
|
Maximum Expiratory Pressure
|
104.31 cm H2O (pressure measurement)
Standard Deviation 70.1
|
SECONDARY outcome
Timeframe: Change in baseline to 7 weeksPopulation: 14 adults with a history of ischemic stroke in the previous 2 years. All but two participants (1 male, 1 female) completed the protocol.
Cough airflow measure of peak expiratory flow rate
Outcome measures
| Measure |
Expiratory Muscle Strength Training (EMST)
n=14 Participants
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).
|
|---|---|
|
Cough Expiratory Airflow
|
2.43 Liters of air/second
Standard Deviation .95
|
Adverse Events
Expiratory Muscle Strength Training (EMST)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place