Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Purdue University

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: Expiratory Muscle Strength Training (EMST-150)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05003167

IRB-2020-524

1F31DC019281-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

A tele-health treatment study for individuals with early stage ALS with the aim to improve communication, cough response, and respiratory strength. All participants complete a respiratory strength training program using an Expiratory Muscle Strength Training (EMST 150) device from the comfort of their homes for 6 weeks.

Full description

The investigators are looking for people with early stage ALS to participate in a completely tele-health (no in-person visits required) treatment study examining the effects of an Expiratory Muscle Strength Training device (EMST-150) on communication, cough, and respiratory strength. Participants will be required to attend 2 virtual baseline assessment sessions followed by 12 additional virtual training sessions (2 per week for 6 weeks). Participants should plan to be actively enrolled in the study for ~10 weeks (3 weeks of baseline monitoring followed by 6 weeks of training). Participants will also be required to fill out a series of questionnaires assessing the EMST's effectiveness via tele-health.

Enrollment: 13 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ALS
• Within the early stages of disease progression (i.e., able to talk, breathe, and eat independently)
• Speaker of English
• Have a family member/caregiver willing to assist as needed
• Have access to an electronic device and internet for tele-health

Exclusion criteria

• A history of neurological disease (besides ALS)
• A history of asthma or respiratory problems (e.g., COPD, emphysema)
• A history of head, neck, or chest surgery (except mastectomy)
• A history of smoking within the last 5 years
• Reliance on mechanical ventilation (including CPAP)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Expiratory Muscle Strength Training

Experimental group

Description:

All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).

Treatment:

Device: Expiratory Muscle Strength Training (EMST-150)