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Withdrawn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

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 |
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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.
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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). |
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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)
- 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)
- 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)
- 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)
- 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
- 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
- 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.
- 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 |
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.

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
United States, Pennsylvania | |
University of Pittsburgh Medical Center Presbyterian Hospital | |
Pittsburgh, Pennsylvania, United States, 15260 |
Principal Investigator: | Cara A Donohue, MA CCC-SLP | University of Pittsburgh | |
Study Chair: | James L Coyle, PhD | University of Pittsburgh |
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 |
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 |
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 |