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Amyotrophic Lateral SclerosisNCT05003167

Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

A study testing Expiratory Muscle Strength Training (EMST-150) in people with Amyotrophic Lateral Sclerosis, run by Purdue University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
Expiratory Muscle Strength Training (EMST-150)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
1 Jan 2021to 1 Jun 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Purdue University

    West Lafayette, Indiana, 47906

Other trials in United States

About this study

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.

Read the 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.

Being tested
Expiratory Muscle Strength Training (EMST-150)
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT05003167
Study groupRoleWhat they receive
Expiratory Muscle Strength TrainingExperimentalAll 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).
Receives: Device: Expiratory Muscle Strength Training (EMST-150)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (11)
  1. Peak Expiratory Flow Rate

    Change in cough strength (as measured by peak expiratory flow rate) throughout the study duration, measured using a flow meter that the participant coughs into - single coughs. Data from baseline 2 and pre-training were averaged for the pre--training value.

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

  2. Change From Baseline to Post-Treatment in Utterance Length

    Change in utterance length (# of syllables produced on one breath) throughout the study duration. Participant read the Rainbow Passage and data were collected from this task.

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

  3. Change From Baseline to Post-Treatment in Number of Pauses

    Change in the total number of pauses that included breathing (breath pauses). Participant read the Rainbow Passage and data were collected from this task.

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

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

    Change in the location of pauses while breathing produced while reading. We determined where participants took breaths while reading the Rainbow Passage and categorized them according to syntax. Categories included at a major boundary (at the end of an independent clause marked by a period) and at a boundary that is not related to syntax (not a major or minor syntactical location). The number of pauses at each category of boundaries were converted to a percent of the total breaths taken while reading the passage.

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

  5. Telehealth Satisfaction

    Participants rated 15 statements with a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Example statements include: I can easily talk to my health-care provider, I can hear my health-care provider clearly, I can see my health-care provider as if we met in person, I think the care provided via telemedicine is consistent, and I receive adequate attention, telemedicine provides for my health care need, and overall, I am satisfied with the quality of service being provided via telemedicine. Total scores range from 0-75 and individual statement scores ranged from 1-5, with higher scores indicating higher satisfaction with the telepractice modality.

    Measured: Post-Training (week 10)

  6. Change From Pre-Training to Post-Training in Communication Participation Item Bank

    Participants were instructed to use a 4-point Likert scale (3: not at all; 2: a little; 1: quite a bit; 0: very much) to rate if/how their ALS impacts ten hypothetical communicative situations. Participants total scores were then added together, ranging from 0-30, and converted to a T-score ranging from 24.2-71.0. High scores are more favorable, indicating that the participant feels that ALS impacts their communicative participation less than those with lower scores.

    Measured: Pre-Training (week 3) and Post-Training (week 10)

  7. Change From Baseline to Post-Treatment in ALS Quality of Life Scale

    The ALS Quality of Life Scale-Revised (ALSQOL-R) (Simmons, 2015) was used to measure how ALS impacts their quality of life in six domains: negative emotion, interaction with people and the environment, intimacy, religiosity, physical symptoms, and bulbar function. Participants rate whether they strongly disagree (0) or strongly agree (10) with 46 statements. Each domain score is given an average value between 0 (worse) and 10 (best). Total scores on the ALSQOL-R range from 0-460, but an average score ranging from 0-10 is computed by dividing the total score by the total number of items completed by the participant (usually 46). Higher scores reflect a higher quality of life. 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.

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

  8. ALS Function Rating Scale Revised

    A survey that quantifies change in disease progression throughout the study duration. Participants rate how 12 physical functions are impacted by their ALS. For each function, participants are provided with a 4-point Likert scale to rate whether they still have complete control of that function (4) or no ability to perform that function (0). Total scores range from 0 to 48, with lower scores indicating more severe symptoms and higher scores and less severe symptoms.

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

  9. Psychosocial Impact of Assistive Devices Scale

    A survey assessing how the training device/modality impacts patient's psychosocial functions. The PIADS includes 12 items for competence, 6 for adaptability, and 8 for self-esteem. Participants use a 7-point Likert scale to rate the impact of a device on each item: a maximum negative impact (-3), somewhat negative impact (-2 or -1), zero impact (0), somewhat positive impact (1 or 2), maximum positive impact (3). Total scores range from -78 (maximum negative impact) to 78 (maximum positive impact).

    Measured: Post-treatment (week 10)

  10. Tele-health Session Attendance

    % of training sessions scheduled and attended by participants throughout the study duration

    Measured: Measured at the end of training across the entire training period

  11. Adherence to Training Protocol

    Number of of training exhalations completed (25 exhalations into the device, 5 days per week) by participants throughout the study duration

    Measured: Measured each week of training across the entire training duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start1 Jan 2021
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants enrolled will receive the intervention.
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003167
Sponsor's protocol ID
IRB-2020-524
Other IDs
1F31DC019281-01
Status last verified
Jun 2023
First submitted
6 Jul 2021
Last updated
8 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Expiratory Muscle Strength Training (EMST-150) in people with Amyotrophic Lateral Sclerosis, run by Purdue University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Post-treatment for Maximum Expiratory Pressure (time frame: Baseline 2 (week 2), Pre-Training (week 3), and Post-Training (week 10)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.

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