MedTrace Logo

Fatigue in Patients With Amyotrophic Lateral Sclerosis

NCT04468191 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-02-15

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Cara Donohue

    lead OTHER

Principal Investigators

  • Cara A Donohue, MA CCC-SLP · University of Pittsburgh

  • James L Coyle, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2021-02-10
Completion
2021-02-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468191 on ClinicalTrials.gov