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Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

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ClinicalTrials.gov Identifier: NCT05003167
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : October 14, 2021
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
HuberLab, Purdue University

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: Expiratory Muscle Strength Training (EMST-150) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants enrolled will receive the intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : May 1, 2022


Arm Intervention/treatment
Experimental: 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).
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).




Primary Outcome Measures :
  1. Maximum expiratory pressure - measured using a pressure meter that the participant blows into [ Time Frame: Baseline 1 (week 1), Baseline 2 (week 2), Pre-Training (week 3), Mid-Training (week 6), Post-Training (week 10) ]
    Change in expiratory muscle strength throughout the study duration


Secondary Outcome Measures :
  1. Peak expiratory flow rate - measured using a flow meter that the participant coughs into [ Time Frame: Baseline 1 (week 1), Baseline 2 (week 2), Pre-Training (week 3), Mid-Training (week 6), Post-Training (week 10) ]
    Change in cough strength throughout the study duration

  2. Utterance length [ Time Frame: Baseline 1 (week 1), Baseline 2 (week 2), Pre-Training (week 3), Mid-Training (week 6), Post-Training (week 10) ]
    Change in utterance length (# of syllables produced on one breath) throughout the study duration

  3. Number of pauses [ Time Frame: Baseline 1 (week 1), Baseline 2 (week 2), Pre-Training (week 3), Mid-Training (week 6), Post-Training (week 10) ]
    Change in the total number of breath pauses produced while reading and conversing throughout the study duration.

  4. Syntactic location of pauses [ Time Frame: Baseline 1 (week 1), Baseline 2 (week 2), Pre-Training (week 3), Mid-Training (week 6), Post-Training (week 10) ]
    Change in the location of breath pauses produced while reading and conversing throughout the study duration.

  5. Telehealth satisfaction [ Time Frame: Post-Training (week 10) ]
    A survey assessing patient's satisfaction with tele-therapy. The survey scores range from 15-75, with higher scores indicating higher satisfaction with tele-therapy.

  6. Communication Participation Item Bank [ Time Frame: Pre-Training (week 3) and Post-Training (week 10) ]
    A survey assessing how each participant feels ALS impacts communicative participation and how it changes throughout the study duration. The survey scores range from 0-30, with higher scores indicating that ALS severely impacts communicative participation.

  7. ALS Quality of Life Scale [ Time Frame: Baseline 1 (week 1), Pre-Training (week 3), Post-Training (week 10) ]
    A survey assessing how each participant feels ALS impacts quality of life, and how that changes throughout the study duration. Total scores range from 0-460, with higher scores indicating greater contributions of ALS to quality of life.

  8. ALS Function Rating Scale Revised [ Time Frame: Baseline 1 (week 1), Baseline 2 (week 2), Pre-Training (week 3), Post-Training (week 10) ]
    A survey that quantifies change in disease progression throughout the study duration

  9. Psychosocial Impact of Assistive Devices Scale [ Time Frame: Post-treatment (week 10) ]
    A survey assessing how the training device/modality impacts patient's psychosocial functions. The scale ranges from -78 to +78, with higher scores indicating positive changes to psychosocial functions.

  10. Tele-health session attendance [ Time Frame: Baseline 1 (week 1), Baseline 2 (week 2), Pre-Training (week 3), Mid-Training (week 6), Post-Training (week 10) ]
    % of training sessions scheduled and attended by participants throughout the study duration

  11. Adherence to training protocol [ Time Frame: Baseline 1 (week 1), Baseline 2 (week 2), Pre-Training (week 3), Mid-Training (week 6), Post-Training (week 20) ]
    # of training exhalations completed (25 exhalations into the device, 5 days per week) by participants throughout the study duration



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05003167


Contacts
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Contact: Brianna Kiefer, MS 209-607-4979 kiefer4@purdue.edu
Contact: Jessica E Huber, PhD 765-494-3796 jhuber@purdue.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47906
Contact: Brianna R Kiefer, MS    765-494-3796    kiefer4@purdue.edu   
Contact: Sandy Snyder, MS    (765) 494-3796    snyder33@purdue.edu   
Principal Investigator: Jessica E Huber, PhD         
Sub-Investigator: Brianna R Kiefer, MS         
Sponsors and Collaborators
Purdue University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Jessica E Huber, Ph.D. Purdue University
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Responsible Party: HuberLab, Professor, SLHS, Purdue University
ClinicalTrials.gov Identifier: NCT05003167    
Other Study ID Numbers: IRB-2020-524
1F31DC019281-01 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases