NCT05003167

Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Purdue University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DEVICE	Expiratory Muscle Strength Training (EMST-150)	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).

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-08-12
• Last updated: 2023-06-08
• Results posted: 2023-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study