A Pilot Study of Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

Study Purpose:

The purpose of this study is to investigate the effects of two treatment techniques called Expiratory Muscle Strength Training (EMST) and Lung Volume Recruitment (LVR) on breathing, swallowing, speech, and cough function in persons with mild to moderate ALS. Half of the participants will do EMST alone, and the other half of the participants will do EMST and LVR.

Disease:

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

Study Type:

Interventional Trial

Study Category:

Procedures: Expiratory Muscle Strength Training (EMST) and EMST + Lung Volume Recruitment (LVR)

Study Status:

Enrolling

Phase:

Not Applicable

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

David Walk, MD, University of Minnesota - Clinical and Translational Science Institute

Clinicaltrials.gov ID (11 digit #):

NCT03202017

Neals Affiliated?

No

Coordinating Center Contact Information

University of Minnesota
Valerie Ferment / .(JavaScript must be enabled to view this email address) / 612-301-1535
.(JavaScript must be enabled to view this email address) Minneapolis, Minnesota 55455 United States

Full Study Summary:

Study Sponsor:

University of Minnesota - Clinical and Translational Science Institute

Participant Duration:

12 weeks

Estimated Enrollment:

24

Estimated Study Start Date:

07/31/2017

Estimated Study Completion Date:

06/01/2020

Posting Last Modified Date:

04/04/2018

Date Study Added to alsconsortium.org:

08/07/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Min Vital Capacity (% predicted normal):

    65

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:
    ALS defined as possible, laboratory-supported probable, probable, or definite by El Escorial criteria
    Reduced Maximal Expiratory Pressure (MEP) compared to norms for age and sex
    Forced Vital Capacity (FVC) > 65% predicted

    Exclusion Criteria:
    Inability to provide informed consent
    Relative contraindications to LVR, including known pneumothorax, active internal bleeding, unstable hypertension, unstable angina, emphysema, recent barotrauma, or FEV1 (Forced Expiratory Volume, trial 1)/FVC ratio < 0.7.
    Use of EMST or breath stacking > 3 days/week within 12 weeks of screening
    Amyotrophic Lateral Sclerosis-Cognitive Behavioral Scale (ALS-CBS) score predictive of dementia (≤ 10)
    Participation in another clinical trial of an intervention in ALS within 30 days of study enrollment or during study enrollment

  • Site Contact Information

    University of Minnesota
    Valerie Ferment / .(JavaScript must be enabled to view this email address) / 612-301-1535
    Minneapolis, Minnesota 55455
    United States