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Quantifying Fatigue of the Respiratory and Swallowing Musculature in Patients With Amyotrophic Lateral Sclerosis

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Cara A Donohue, MA CCC-SLP University of Pittsburgh

Clinicaltrials.gov ID (11 digit #):

NCT04468191

Neals Affiliated?

No

Coordinating Center Contact Information

University of Pittsburgh Medical Center Presbyterian Hospital
Cara A Donohue, MA CCC-SLP / .(JavaScript must be enabled to view this email address) / 724-307-8309
James L Coyle, PhD / .(JavaScript must be enabled to view this email address) / 412-383-6608
Pittsburgh, Pennsylvania 15260 United States

Full Study Summary:

Study Sponsor:

University of Pittsburgh

Participant Duration:

Estimated Enrollment:

20

Estimated Study Start Date:

09/01/2020

Estimated Study Completion Date:

03/01/2021

Posting Last Modified Date:

10/13/2020

Date Study Added to alsconsortium.org:

07/27/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    100

    Min Vital Capacity (% predicted normal):

    65

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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.

  • Site Contact Information

    University of Pittsburgh Medical Center Presbyterian Hospital
    Cara A Donohue, MA CCC-SLP / .(JavaScript must be enabled to view this email address) / 724-307-8309
    James L Coyle, PhD / .(JavaScript must be enabled to view this email address) / 412-383-6608
    Pittsburgh, Pennsylvania 15260
    United States