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.

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:

NCT03202017

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