Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

NCT05003167 | Completed Results DMC FDA Device

• 2 other identifiers: IRB-2020-5241F31DC019281-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Post-treatment for Maximum Expiratory Pressure

  Change in expiratory muscle strength throughout the study duration measured by the participant blowing into a pressure meter

  Baseline 2 (week 2), Pre-Training (week 3), and Post-Training (week 10)

Secondary Outcomes (11)

• Peak Expiratory Flow Rate

  Baseline 2 (week 2), Pre-training (week 3), Post-Training (week 10)

• Change From Baseline to Post-Treatment in Utterance Length

  Baseline 1 (week 1) and Post-Training (week 10)

• Change From Baseline to Post-Treatment in Number of Pauses

  Baseline 1 (week 1) and Post-Training (week 10)

• Change From Baseline to Post-Treatment in Syntactic Location of Pauses

  Baseline 1 (week 1) and Post-Training (week 10)

• Telehealth Satisfaction

  Post-Training (week 10)

Study Arms (1)

Expiratory Muscle Strength Training

EXPERIMENTAL

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).

Device: Expiratory Muscle Strength Training (EMST-150)

Interventions

Expiratory Muscle Strength Training (EMST-150) 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).

Expiratory Muscle Strength Training

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Purdue University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The sample size was small. Participants enrolled in the current study likely had a preference or at least approval of telepractice prior to enrollment, since the recruitment materials stated that it was a telepractice study, and participants reached out to the researchers to express interest knowing that the study would be conducted through telepractice. Along similar lines, participants in the current study were highly educated and likely technologically savvy.

Results Point of Contact

• Title: Jessica Huber, Professor and PI
• Organization: Purdue University

jhuber@purdue.edu

765-494-3796

Study Officials

• Jessica E Huber, Ph.D.

  Purdue University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, SLHS

Model Details: All participants enrolled will receive the intervention.

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 12, 2021
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 8, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)