Fatigue in Patients With Amyotrophic Lateral Sclerosis

NCT04468191 | Withdrawn FDA Device

• 1 other identifier: STUDY20060082
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis; Dysphagia; Dyspnea; Respiration Disorders

Outcome Measures

Primary Outcomes (12)

• Change in forced vital capacity (FVC) between pre and post expiratory muscle strength training (EMST) experimental session

  FVC is a measure of the total amount of air that can be breathed out during a pulmonary function test to measure lung function.

  pre and post EMST experimental session, up to 2 weeks

• Change in forced vital capacity (FVC) between pre and post expiratory muscle strength training (EMST) sham session

  FVC is a measure of the total amount of air that can be breathed out during a pulmonary function test to measure lung function.

  pre and post EMST sham session, up to 2 weeks

• Change in peak cough flow (PCF) between pre and post expiratory muscle strength training (EMST) experimental session

  PCF is a measure of air flow during a cough.

  pre and post EMST experimental session, up to 2 weeks

• Change in peak cough flow (PCF) between pre and post expiratory muscle strength training (EMST) sham session

  PCF is a measure of air flow during a cough.

  pre and post EMST sham session, up to 2 weeks

• Change in maximum expiratory pressure (MEP) between pre and post expiratory muscle strength training (EMST) experimental session

  Maximum expiratory pressure is a measure of strength of the respiratory muscles when breathing out

  pre and post EMST experimental session, up to 2 weeks

• Change in maximum expiratory pressure (MEP) between pre and post expiratory muscle strength training (EMST) sham session

  Maximum expiratory pressure is a measure of strength of the respiratory muscles when breathing out

  pre and post EMST sham session, up to 2 weeks

• Change in temporal kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) experimental session

  Timing measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in frames per second)

  pre and post EMST experimental session, up to 2 weeks

• Change in temporal kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) sham session

  Timing measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in frames per second)

  pre and post EMST sham session, up to 2 weeks

• Change in spatial kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) experimental session

  Distance measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in pixels)

  pre and post EMST experimental session, up to 2 weeks

• Change in spatial kinematic measures of swallowing between pre and post expiratory muscle strength training (EMST) sham session

  Distance measures of physiological events that occur during swallowing based on videofluoroscopic swallow studies (measured in pixels)

  pre and post EMST sham session, up to 2 weeks

• Change in Modified Barium Swallow Impairment Profile (MBSImP) scores of swallowing between pre and post expiratory muscle strength training (EMST) experimental session

  The MBSImP is a standardized clinical ordinal, categorical rating tool of 17 physiological components of swallowing

  pre and post EMST experimental session, up to 2 weeks

• Change in Modified Barium Swallow Impairment Profile (MBSImP) scores of swallowing between pre and post expiratory muscle strength training (EMST) sham session

  The MBSImP is a standardized clinical ordinal, categorical rating tool of 17 physiological components of swallowing

  pre and post EMST sham session, up to 2 weeks

Secondary Outcomes (2)

• Change in high resolution cervical auscultation (HRCA) signal features between pre and post expiratory muscle strength training (EMST) experimental session

  pre and post EMST experimental session, up to 2 weeks

• Change in high resolution cervical auscultation (HRCA) signal features between pre and post expiratory muscle strength training (EMST) sham session

  pre and post EMST sham session, up to 2 weeks

Study Arms (2)

Experimental, then sham

EXPERIMENTAL

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); Device: Sham expiratory muscle strength training (EMST)

Sham, then experimental

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); Device: Sham expiratory muscle strength training (EMST)

Interventions

Experimental expiratory muscle strength training (EMST) 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.

Experimental, then sham; Sham, then experimental

Sham expiratory muscle strength training (EMST) DEVICE

The sham EMST will involve blowing into a device without a spring-loaded valve (0% resistance).

Experimental, then sham; Sham, then experimental

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cara Donohue: lead

Study Sites (1)

University of Pittsburgh Medical Center Presbyterian Hospital

Pittsburgh, Pennsylvania, 15260, United States

Location

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MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Deglutition Disorders; Dyspnea; Respiration Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cara A Donohue, MA CCC-SLP

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• James L Coyle, PhD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MA CCC-SLP/PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 13, 2020
• Study Start: February 10, 2021
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)