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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Procedure
Intervention Name:
Expiratory Muscle Strength Training (EMST), EMST + Lung Volume Recruitment (LVR)
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
David Walk, MD, University of Minnesota
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
University of Minnesota
Minneapolis, Minnesota, 55455 United States
Study Sponsor:
University of Minnesota
Participant Duration:
12 weeks
Estimated Enrollment:
23
Estimated Study Start Date:
03 / 01 / 2018
Estimated Study Completion Date:
12 / 30 / 2022
Posting Last Modified Date:
02 / 23 / 2023
Date Study Added to neals.org:
06 / 28 / 2017
Minimum Age:
18 Years
Maximum Age:
N/A
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
University of Florida
Gainesville, Florida
32611
United States
University of Minnesota
Minneapolis, Minnesota
55455
United States