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?

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:

Estimated Study Start Date:

03/01/2018

Estimated Study Completion Date:

12/31/2021

Posting Last Modified Date:

05/14/2019

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 Florida
Kelby Magennis / .(JavaScript must be enabled to view this email address) / 352-273-8632
Gainesville, Florida 32611
United States

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