Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2021-02-10
Study Completion Date
2021-02-10
Brief Summary
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Expiratory muscle strength training (EMST) is an emerging palliative intervention for prolonging pulmonary and swallow function in patients with amyotrophic lateral sclerosis (PALS), but it is unknown whether EMST may result in detrimental immediate to short-term fatigue because there is no way to measure fatigue non-invasively. This study will determine the immediate to short-term impact of EMST on objective respiratory and swallow function, whether subjective ratings of dyspnea and fatigue map to objective decompensation of respiratory and swallow function, and the ability to monitor fatigue of the respiratory and swallowing musculature non-invasively. Findings from this research study will provide preliminary evidence regarding optimal timing for PALS to complete EMST and will provide PALS and clinicians increased capabilities to monitor fatigue non-invasively.
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Detailed Description
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This research proposal will determine the immediate impact of expiratory muscle strength training (EMST) on fatigue of the respiratory and swallowing musculature, whether objective decompensation translates to subjective dyspnea and fatigue, and whether high resolution cervical auscultation (HRCA) signal features can noninvasively capture and characterize physiologic decompensation that relates to fatigue in patients with amyotrophic lateral sclerosis (PALS) via three Specific Aims.
Aim 1) Determine the impact of one EMST session on objective respiratory and swallow function.
Hypothesis 1) One EMST session will result in reduced pulmonary function tests (PFTs) (maximum expiratory pressure, forced vital capacity, peak cough flow) and declines in swallow function (Videofluoroscopy (VF), HRCA). PALS will have greater reductions in PFTs, and objective declines in swallow function after the experimental condition compared to the control condition.
Aim 2) Determine if objective decompensation translates to subjective ratings of dyspnea and fatigue after one EMST session.
Hypothesis 2) Subjective ratings of dyspnea and fatigue (Situational Fatigue Scale; Dyspnea ALS-15) will be associated with objective decompensation in respiratory and swallow function (PFTs, VF, HRCA) after one EMST session.
Aim 3) Investigate whether HRCA signal features analyses can non-invasively characterize immediate post-exercise physiologic changes in swallowing function that are related to fatigue.
Hypothesis 3) Pre- to post-EMST changes in HRCA signal features will be associated with physiologic changes in swallowing as measured by VF analyses.
This study will be a prospective study with randomized experimental and control conditions; and is directly related to the NIH funded research studies currently conducted in the Computational Deglutition (CD) Lab under the leadership of Dr. James Coyle and Dr. Ervin Sejdic.
Participants: 20 PALS will be recruited to undergo VF before and after undergoing the randomly ordered experimental and control conditions on two separate nonconsecutive days within a two-week time frame.
Baseline Procedures:
PALS will be instructed not to eat a meal or engage in exercise within two hours of their visit. Following consent, baseline assessment procedures be obtained. All baseline measurements of swallowing and pulmonary function will be performed before any potentially fatigue-inducing procedures are performed (i.e. exercise training).
1. The ALS functional rating scale revised (ALSFRS-R) (an instrument used to assess changes in functional status over time in PALS), will be completed.
2. Prior to completing swallowing and pulmonary measurements, PALS will complete the situational fatigue scale (SFS), which measures fatigue that results from completing functional daily activities.
3. Before undergoing swallowing and pulmonary measurements, PALS will also complete the Dyspnea ALS-15 (DALS-15), which is a measure of dyspnea that is known to be related to fatigue in PALS.
4. PALS will undergo an assessment of swallow function with concurrent recordings of videofluoroscopy (VF) and high-resolution cervical auscultation (HRCA) signals prior to undergoing PFTs to mitigate fatigue from the PFTs as a confound. VF procedures will be conducted first, because ten swallows of thin liquid are unlikely to cause fatigue of the respiratory and swallow musculature that would impact PFTs.
5. PALS will be seated upright in a chair and viewed in the lateral plane. HRCA signals will be simultaneously recorded from neck sensors (a contact microphone and accelerometer) that are attached to the anterior laryngeal framework with tape. VF and HRCA signals will be recorded onto a Labview Workstation. During each stage (pre-, post EMST) of VF, PALS will swallow ten thin liquid boluses of barium. Five liquid swallows will be a self-selected comfortable sip from a cup and five will be 3mL by spoon administered with a command to swallow. Presentation order for the liquid swallows will be randomized using a random number generator. If more than one aspiration event is observed during VF, the exam will be terminated immediately in order to ensure patient safety.
6. PFTs following VF will include maximum expiratory pressure (MEP) (measured with the MicroRPM handheld MEP device (Micro Direct Inc., Lewiston, ME)), peak cough flow (PCF) (measured with a handheld peak flow meter (BV Medical, Barrington, IL)), and FVC (measured with the Spirodoc spirometer and WinspiroPRO computer software (Medical International Research, New Berlin, WI)). All PFTs will be completed three times with PALS sitting in an upright seated position with a nose clip in line with standard PFT protocols. The highest of three measurements will be used for analyses.
EMST Training: PALS will use the EMST-150 device (Aspire Products, Gainesville, Florida) or the Philips Threshold PEP trainer (Philips Respironics, Cedar Grove, New Jersey). During the experimental condition, EMST devices will be set to 50% of PALS' highest MEP from their baseline PFT assessment. During the control condition, no resistance will be added, and the loaded spring will be removed from the device. For both experimental conditions, PALS will undergo the following standard treatment protocol:
1. PALS will complete five sets of five repetitions using an EMST device.
2. For each repetition, PALS will be instructed to take a deep breath in and blow until the valve releases.
3. Between repetitions, PALs will have 10-15 seconds of rest before the next repetition.
4. After each set, PALS will rest for one minute before completing the next set.
Post-treatment procedures: Following the EMST session with either the device set to 50% load or the sham device, PALS will undergo the same procedures (VF, HRCA, PFTs) as described above in steps 1-6 of the baseline procedures
Aim 1) Determine the impact of one EMST session on objective respiratory and swallow function.
Hypothesis 1) One EMST session will result in reduced pulmonary function tests (PFTs) (maximum expiratory pressure, forced vital capacity, peak cough flow) and declines in swallow function (Videofluoroscopy (VF), HRCA). PALS will have greater reductions in PFTs, and objective declines in swallow function after the experimental condition compared to the control condition.
Aim 2) Determine if objective decompensation translates to subjective ratings of dyspnea and fatigue after one EMST session.
Hypothesis 2) Subjective ratings of dyspnea and fatigue (Situational Fatigue Scale; Dyspnea ALS-15) will be associated with objective decompensation in respiratory and swallow function (PFTs, VF, HRCA) after one EMST session.
Aim 3) Investigate whether HRCA signal features analyses can non-invasively characterize immediate post-exercise physiologic changes in swallowing function that are related to fatigue.
Hypothesis 3) Pre- to post-EMST changes in HRCA signal features will be associated with physiologic changes in swallowing as measured by VF analyses.
This study will be a prospective study with randomized experimental and control conditions; and is directly related to the NIH funded research studies currently conducted in the Computational Deglutition (CD) Lab under the leadership of Dr. James Coyle and Dr. Ervin Sejdic.
Participants: 20 PALS will be recruited to undergo VF before and after undergoing the randomly ordered experimental and control conditions on two separate nonconsecutive days within a two-week time frame.
Baseline Procedures:
PALS will be instructed not to eat a meal or engage in exercise within two hours of their visit. Following consent, baseline assessment procedures be obtained. All baseline measurements of swallowing and pulmonary function will be performed before any potentially fatigue-inducing procedures are performed (i.e. exercise training).
1. The ALS functional rating scale revised (ALSFRS-R) (an instrument used to assess changes in functional status over time in PALS), will be completed.
2. Prior to completing swallowing and pulmonary measurements, PALS will complete the situational fatigue scale (SFS), which measures fatigue that results from completing functional daily activities.
3. Before undergoing swallowing and pulmonary measurements, PALS will also complete the Dyspnea ALS-15 (DALS-15), which is a measure of dyspnea that is known to be related to fatigue in PALS.
4. PALS will undergo an assessment of swallow function with concurrent recordings of videofluoroscopy (VF) and high-resolution cervical auscultation (HRCA) signals prior to undergoing PFTs to mitigate fatigue from the PFTs as a confound. VF procedures will be conducted first, because ten swallows of thin liquid are unlikely to cause fatigue of the respiratory and swallow musculature that would impact PFTs.
5. PALS will be seated upright in a chair and viewed in the lateral plane. HRCA signals will be simultaneously recorded from neck sensors (a contact microphone and accelerometer) that are attached to the anterior laryngeal framework with tape. VF and HRCA signals will be recorded onto a Labview Workstation. During each stage (pre-, post EMST) of VF, PALS will swallow ten thin liquid boluses of barium. Five liquid swallows will be a self-selected comfortable sip from a cup and five will be 3mL by spoon administered with a command to swallow. Presentation order for the liquid swallows will be randomized using a random number generator. If more than one aspiration event is observed during VF, the exam will be terminated immediately in order to ensure patient safety.
6. PFTs following VF will include maximum expiratory pressure (MEP) (measured with the MicroRPM handheld MEP device (Micro Direct Inc., Lewiston, ME)), peak cough flow (PCF) (measured with a handheld peak flow meter (BV Medical, Barrington, IL)), and FVC (measured with the Spirodoc spirometer and WinspiroPRO computer software (Medical International Research, New Berlin, WI)). All PFTs will be completed three times with PALS sitting in an upright seated position with a nose clip in line with standard PFT protocols. The highest of three measurements will be used for analyses.
EMST Training: PALS will use the EMST-150 device (Aspire Products, Gainesville, Florida) or the Philips Threshold PEP trainer (Philips Respironics, Cedar Grove, New Jersey). During the experimental condition, EMST devices will be set to 50% of PALS' highest MEP from their baseline PFT assessment. During the control condition, no resistance will be added, and the loaded spring will be removed from the device. For both experimental conditions, PALS will undergo the following standard treatment protocol:
1. PALS will complete five sets of five repetitions using an EMST device.
2. For each repetition, PALS will be instructed to take a deep breath in and blow until the valve releases.
3. Between repetitions, PALs will have 10-15 seconds of rest before the next repetition.
4. After each set, PALS will rest for one minute before completing the next set.
Post-treatment procedures: Following the EMST session with either the device set to 50% load or the sham device, PALS will undergo the same procedures (VF, HRCA, PFTs) as described above in steps 1-6 of the baseline procedures
Conditions
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Amyotrophic Lateral Sclerosis
Dysphagia
Dyspnea
Respiration Disorders
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
This study will be a prospective study with randomized experimental and control conditions. Patients with ALS will undergo the experimental and control conditions in random order on two separate days within a two-week time frame.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
During the experimental condition, expiratory muscle strength training (EMST) devices will be set to 50% of patients with ALS' highest maximum expiratory pressure from their baseline pulmonary function test assessment. During the control condition, no resistance will be added, and the loaded spring will be removed from the device. For both experimental conditions, patients with ALS will be blinded to condition.
Study Groups
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Experimental, then sham
Patients with ALS in the experimental, then sham arm will undergo an expiratory muscle strength training (EMST) session with a device set to 50% of patients with ALS' highest maximum expiratory pressure from their baseline pulmonary function test assessment during their first study visit. Then, during their second study visit, patients with ALS will undergo an EMST session with a device set to 0% resistance.
Group Type
EXPERIMENTAL
Experimental expiratory muscle strength training (EMST)
Intervention Type
DEVICE
The experimental EMST will involve blowing into a device with a spring-loaded valve set to 50% of the patient with ALS' maximum expiratory pressure.
Sham expiratory muscle strength training (EMST)
Intervention Type
DEVICE
The sham EMST will involve blowing into a device without a spring-loaded valve (0% resistance).
Sham, then experimental
Patients with ALS in the sham, then experimental arm will undergo an expiratory muscle strength training (EMST) session with a device set to 0% resistance during their first study visit. Then, during their second study visit, patients with ALS will undergo an EMST session with a device set to 50% of patients with ALS' highest maximum expiratory pressure from their baseline pulmonary function test assessment.
Group Type
EXPERIMENTAL
Experimental expiratory muscle strength training (EMST)
Intervention Type
DEVICE
The experimental EMST will involve blowing into a device with a spring-loaded valve set to 50% of the patient with ALS' maximum expiratory pressure.
Sham expiratory muscle strength training (EMST)
Intervention Type
DEVICE
The sham EMST will involve blowing into a device without a spring-loaded valve (0% resistance).
Interventions
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Experimental expiratory muscle strength training (EMST)
The experimental EMST will involve blowing into a device with a spring-loaded valve set to 50% of the patient with ALS' maximum expiratory pressure.
Intervention Type
DEVICE
Sham expiratory muscle strength training (EMST)
The sham EMST will involve blowing into a device without a spring-loaded valve (0% resistance).
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ALS defined as possible, probable, or definite by a neurologist using the El Escorial criteria
* FVC\>65% predicted
* adequate cognition as defined by a score of \>10 on the ALS Cognitive Behavioral Screen
* adequate labial seal for completing pulmonary function tests and expiratory muscle strength training (EMST)
* on a regular/thin liquid diet
* no allergies to barium
* not oxygen-dependent
* no tracheostomy/ mechanical ventilation
* no history of other neurological or respiratory disorders
* no history of smoking
* no history of head and neck cancer or other major head/neck surgery or radiation therapy.
* FVC\>65% predicted
* adequate cognition as defined by a score of \>10 on the ALS Cognitive Behavioral Screen
* adequate labial seal for completing pulmonary function tests and expiratory muscle strength training (EMST)
* on a regular/thin liquid diet
* no allergies to barium
* not oxygen-dependent
* no tracheostomy/ mechanical ventilation
* no history of other neurological or respiratory disorders
* no history of smoking
* no history of head and neck cancer or other major head/neck surgery or radiation therapy.
Exclusion Criteria
* FVC\<65% predicted
* inadequate cognition as defined by a score of \<10 on the ALS Cognitive Behavioral Screen -inadequate labial seal for completing pulmonary function tests and expiratory muscle strength training (EMST)
* not on a regular/thin liquid diet
* allergies to barium
* oxygen-dependent
* presence of tracheostomy/dependent on mechanical ventilation
* history of other neurological or respiratory disorders
* history of smoking
* history of head and neck cancer or other major head/neck surgery or radiation therapy.
* inadequate cognition as defined by a score of \<10 on the ALS Cognitive Behavioral Screen -inadequate labial seal for completing pulmonary function tests and expiratory muscle strength training (EMST)
* not on a regular/thin liquid diet
* allergies to barium
* oxygen-dependent
* presence of tracheostomy/dependent on mechanical ventilation
* history of other neurological or respiratory disorders
* history of smoking
* history of head and neck cancer or other major head/neck surgery or radiation therapy.
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Cara Donohue
OTHER
Sponsor Role
lead
Responsible Party
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Cara Donohue
MA CCC-SLP/PhD Student
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Cara A Donohue, MA CCC-SLP
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
James L Coyle, PhD
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
References
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BACKGROUND
Jestrovic I, Dudik JM, Luan B, Coyle JL, Sejdic E. The effects of increased fluid viscosity on swallowing sounds in healthy adults. Biomed Eng Online. 2013 Sep 10;12:90. doi: 10.1186/1475-925X-12-90.
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Dudik JM, Kurosu A, Coyle JL, Sejdic E. A statistical analysis of cervical auscultation signals from adults with unsafe airway protection. J Neuroeng Rehabil. 2016 Jan 22;13:7. doi: 10.1186/s12984-015-0110-9.
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Dudik JM, Jestrovic I, Luan B, Coyle JL, Sejdic E. Characteristics of Dry Chin-Tuck Swallowing Vibrations and Sounds. IEEE Trans Biomed Eng. 2015 Oct;62(10):2456-64. doi: 10.1109/TBME.2015.2431999. Epub 2015 May 12.
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Sejdic E, Dudik JM, Kurosu A, Jestrovic I, Coyle JL. Understanding differences between healthy swallows and penetration-aspiration swallows via compressive sensing of tri-axial swallowing accelerometry signals. Proc SPIE Int Soc Opt Eng. 2014 May 23;9190:91090M. doi: 10.1117/12.2050356.
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BACKGROUND
Dudik JM, Coyle JL, El-Jaroudi A, Mao ZH, Sun M, Sejdic E. Deep Learning for Classification of Normal Swallows in Adults. Neurocomputing (Amst). 2018 Apr 12;285:1-9. doi: 10.1016/j.neucom.2017.12.059. Epub 2018 Jan 31.
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BACKGROUND
He Q, Perera S, Khalifa Y, Zhang Z, Mahoney AS, Sabry A, Donohue C, Coyle JL, Sejdic E. The Association of High Resolution Cervical Auscultation Signal Features With Hyoid Bone Displacement During Swallowing. IEEE Trans Neural Syst Rehabil Eng. 2019 Sep;27(9):1810-1816. doi: 10.1109/TNSRE.2019.2935302. Epub 2019 Aug 21.
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Zhang Z, Perera S, Donohue C, Kurosu A, Mahoney AS, Coyle JL, Sejdic E. The Prediction of Risk of Penetration-Aspiration Via Hyoid Bone Displacement Features. Dysphagia. 2020 Feb;35(1):66-72. doi: 10.1007/s00455-019-10000-5. Epub 2019 Mar 27.
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Mao S, Zhang Z, Khalifa Y, Donohue C, Coyle JL, Sejdic E. Neck sensor-supported hyoid bone movement tracking during swallowing. R Soc Open Sci. 2019 Jul 10;6(7):181982. doi: 10.1098/rsos.181982. eCollection 2019 Jul.
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Donohue C, Mao S, Sejdic E, Coyle JL. Tracking Hyoid Bone Displacement During Swallowing Without Videofluoroscopy Using Machine Learning of Vibratory Signals. Dysphagia. 2021 Apr;36(2):259-269. doi: 10.1007/s00455-020-10124-z. Epub 2020 May 17.
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Khalifa Y, Donohue C, Coyle JL, Sejdic E. Upper Esophageal Sphincter Opening Segmentation With Convolutional Recurrent Neural Networks in High Resolution Cervical Auscultation. IEEE J Biomed Health Inform. 2021 Feb;25(2):493-503. doi: 10.1109/JBHI.2020.3000057. Epub 2021 Feb 5.
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Donohue C, Khalifa Y, Perera S, Sejdic E, Coyle JL. A Preliminary Investigation of Whether HRCA Signals Can Differentiate Between Swallows from Healthy People and Swallows from People with Neurodegenerative Diseases. Dysphagia. 2021 Aug;36(4):635-643. doi: 10.1007/s00455-020-10177-0. Epub 2020 Sep 5.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY20060082
Identifier Type: -
Identifier Source: org_study_id
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