Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

NCT ID: NCT05003167

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-06-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Expiratory Muscle Strength Training

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).

Group Type: EXPERIMENTAL

Expiratory Muscle Strength Training (EMST-150)

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

HuberLab

Professor, SLHS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica E Huber, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1F31DC019281-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-2020-524

Identifier Type: -

Identifier Source: org_study_id