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Fatigue in Patients With Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT04468191
Recruitment Status : Withdrawn (COVID-19 pandemic restrictions for data collection)
First Posted : July 13, 2020
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Cara Donohue, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Dysphagia Dyspnea Respiration Disorders Device: Experimental expiratory muscle strength training (EMST) Device: Sham expiratory muscle strength training (EMST) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Quantifying Fatigue of the Respiratory and Swallowing Musculature in Patients With Amyotrophic Lateral Sclerosis
Actual Study Start Date : February 10, 2021
Actual Primary Completion Date : February 10, 2021
Actual Study Completion Date : February 10, 2021


Arm Intervention/treatment
Experimental: 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.
Device: 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.

Device: Sham expiratory muscle strength training (EMST)
The sham EMST will involve blowing into a device without a spring-loaded valve (0% resistance).

Experimental: 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.
Device: 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.

Device: Sham expiratory muscle strength training (EMST)
The sham EMST will involve blowing into a device without a spring-loaded valve (0% resistance).




Primary Outcome Measures :
  1. Change in forced vital capacity (FVC) between pre and post expiratory muscle strength training (EMST) experimental session [ Time Frame: pre and post EMST experimental session, up to 2 weeks ]
    FVC is a measure of the total amount of air that can be breathed out during a pulmonary function test to measure lung function.

  2. Change in forced vital capacity (FVC) between pre and post expiratory muscle strength training (EMST) sham session [ Time Frame: pre and post EMST sham session, up to 2 weeks ]
    FVC is a measure of the total amount of air that can be breathed out during a pulmonary function test to measure lung function.

  3. Change in peak cough flow (PCF) between pre and post expiratory muscle strength training (EMST) experimental session [ Time Frame: pre and post EMST experimental session, up to 2 weeks ]
    PCF is a measure of air flow during a cough.

  4. Change in peak cough flow (PCF) between pre and post expiratory muscle strength training (EMST) sham session [ Time Frame: pre and post EMST sham session, up to 2 weeks ]
    PCF is a measure of air flow during a cough.

  5. Change in maximum expiratory pressure (MEP) between pre and post expiratory muscle strength training (EMST) experimental session [ Time Frame: pre and post EMST experimental session, up to 2 weeks ]
    Maximum expiratory pressure is a measure of strength of the respiratory muscles when breathing out

  6. Change in maximum expiratory pressure (MEP) between pre and post expiratory muscle strength training (EMST) sham session [ Time Frame: pre and post EMST sham session, up to 2 weeks ]
    Maximum expiratory pressure is a measure of strength of the respiratory muscles when breathing out

  7. Change in temporal kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) experimental session [ Time Frame: pre and post EMST experimental session, up to 2 weeks ]
    Timing measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in frames per second)

  8. Change in temporal kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) sham session [ Time Frame: pre and post EMST sham session, up to 2 weeks ]
    Timing measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in frames per second)

  9. Change in spatial kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) experimental session [ Time Frame: pre and post EMST experimental session, up to 2 weeks ]
    Distance measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in pixels)

  10. Change in spatial kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) sham session [ Time Frame: pre and post EMST sham session, up to 2 weeks ]
    Distance measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in pixels)

  11. Change in Modified Barium Swallow Impairment Profile (MBSImP) scores of swallowing between pre and post expiratory muscle strength training (EMST) experimental session [ Time Frame: pre and post EMST experimental session, up to 2 weeks ]
    The MBSImP is a standardized clinical ordinal, categorical rating tool of 17 physiological components of swallowing

  12. Change in Modified Barium Swallow Impairment Profile (MBSImP) scores of swallowing between pre and post expiratory muscle strength training (EMST) sham session [ Time Frame: pre and post EMST sham session, up to 2 weeks ]
    The MBSImP is a standardized clinical ordinal, categorical rating tool of 17 physiological components of swallowing


Secondary Outcome Measures :
  1. Change in high resolution cervical auscultation (HRCA) signal features between pre and post expiratory muscle strength training (EMST) experimental session [ Time Frame: pre and post EMST experimental session, up to 2 weeks ]
    Feature extraction and analyses from HRCA will be completed before and after each EMST session and compared to VF to determine whether HRCA can detect fatigue related changes in swallow function.

  2. Change in high resolution cervical auscultation (HRCA) signal features between pre and post expiratory muscle strength training (EMST) sham session [ Time Frame: pre and post EMST sham session, up to 2 weeks ]
    Feature extraction and analyses from HRCA will be completed before and after each EMST session and compared to VF to determine whether HRCA can detect fatigue related changes in swallow function.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468191


Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
Cara Donohue
Investigators
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Principal Investigator: Cara A Donohue, MA CCC-SLP University of Pittsburgh
Study Chair: James L Coyle, PhD University of Pittsburgh
Publications:
Harkawik, R., Coyle, J.L. Exercise for better ALS management? ASHA Leader. 2012; 17(11). http://leader.pubs.asha.org/article.aspx?articleid=2292004
Prabhu DNF, Reddy NP, Canilang EP. Neural networks for recognition of acceleration pattern during swallowing and coughing. Proceedings of 16th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.1994; 1105-1106.
Sabry A, Shitong M, Mahoney A, Khalifa Y, Sejdic E, Coyle J. Automatic estimation of laryngeal vestibular closure duration using high resolution cervical auscultation signals. Presentation at the American Speech-Language Hearing Association Convention, Orlando, FL. 2019.
Donohue C, Zhenwei Z, Mahoney A, Perera S, Sejdic E, Coyle J. Do machine ratings of hyoid bone displacement during videofluoroscopy match clinician ratings using the MBSImP? Presentation at the American Speech-Language Hearing Association Annual Meeting, Boston, MA. November 2018.
Sabry A, Mahoney A, Perera S, Sejdic E, Coyle J. Are HRCA signal features associated with clinical ratings of pharyngeal residue using the MBSImP? Presentation at the Dysphagia Research Society Annual Meeting, San Diego, CA. March 2019.
Homepage - ALS Association. ALSA.org. http://www.alsa.org/. Accessed April 10, 2019.
Patchett KK, Hausenblas HA, Christine M. Expiratory Muscle Strength Training for Dysphagia in Chronic Obstructive Pulmonary Disease: A Meta-analysis and Systematic Review. 2017;(August 2015).
Malatra I. Respiratory Muscle Fatigue and the Effects on Swallowing. ProQuest. 2016.
Donohue C, Coyle JL. Impact of respiratory interventions on pulmonary, cough, and swallowing in ALS. ASHA Perspectives. Under review.
Moore VC. Spirometry: Step by step. Breathe, 2012; 8(3), 233-240. https://doi.org/10.1183/20734735.0021711

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Responsible Party: Cara Donohue, MA CCC-SLP/PhD Student, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04468191    
Other Study ID Numbers: STUDY20060082
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory