Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS

University of Minnesota (UMN)

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Procedure: EMST + Lung Volume Recruitment (LVR); Procedure: Expiratory Muscle Strength Training (EMST)

Study type: Interventional

Funder types: Other

Identifiers

NCT03202017

NEUR-2017-25778

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Expiratory Muscle Strength Testing (EMST)

Active Comparator group

Description:

EMST is a treatment method that has been used to improve cough function and swallowing in ALS. EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week.

Treatment:

Procedure: Expiratory Muscle Strength Training (EMST)

EMST + Lung Volume Recruitment (LVR)

Active Comparator group

Description:

EMST is a treatment method that has been used to improve cough function and swallowing in ALS. EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week. LVR is a technique to increase cough function that is performed with a resuscitation bag fitted with a mouthpiece and a one-way valve. The bag is used to expand the lungs, after which the patient makes a voluntary cough.

Treatment:

Procedure: EMST + Lung Volume Recruitment (LVR)