NCT05003167

Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Completed NA Results posted Last updated 8 June 2023

What this trial tests

NA trial testing Expiratory Muscle Strength Training (EMST-150) in Amyotrophic Lateral Sclerosis in 13 participants. Completed in 1 June 2022.

Timeline

1 January 2021

Primary endpoint
1 June 2022

1 June 2022

Quick facts

Lead sponsor	Purdue University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 January 2021
Primary completion	1 June 2022
Estimated completion	1 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Expiratory Muscle Strength Training (EMST-150)

Conditions studied

• Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Purdue University

Who can join

Adults 40 to 70, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to Post-treatment for Maximum Expiratory Pressure Primary · Baseline 2 (week 2), Pre-Training (week 3), and Post-Training (week 10)

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

Pre-training average

Group	Value	95% CI
Expiratory Muscle Strength Training	66.10	± 41.77

Post-training (week 10)

Group	Value	95% CI
Expiratory Muscle Strength Training	83.75	± 45.99

Peak Expiratory Flow Rate Secondary · Baseline 2 (week 2), Pre-training (week 3), Post-Training (week 10)

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.

Pre-training average

Group	Value	95% CI
Expiratory Muscle Strength Training	265.97	± 141.47

Post-training (week 10)

Group	Value	95% CI
Expiratory Muscle Strength Training	273.47	± 127.69

Change From Baseline to Post-Treatment in Utterance Length Secondary · Baseline 1 (week 1) and Post-Training (week 10)

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.

Baseline (reading) - week 1

Group	Value	95% CI
Expiratory Muscle Strength Training	10.76	± 3.29

Post-training (reading) - week 10

Group	Value	95% CI
Expiratory Muscle Strength Training	10.39	± 4.11

Change From Baseline to Post-Treatment in Number of Pauses Secondary · Baseline 1 (week 1) and Post-Training (week 10)

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

Baseline (reading) - week 1

Group	Value	95% CI
Expiratory Muscle Strength Training	15.89	± 8.28

Post-training (reading) - week 10

Group	Value	95% CI
Expiratory Muscle Strength Training	16.75	± 10.99

Change From Baseline to Post-Treatment in Syntactic Location of Pauses Secondary · Baseline 1 (week 1) and Post-Training (week 10)

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.

Baseline, major boundaries

Group	Value	95% CI
Expiratory Muscle Strength Training	47.12	± 37.59

Post-training, major boundaries

Group	Value	95% CI
Expiratory Muscle Strength Training	46.09	± 18.92

Baseline, boundaries unrelated to syntax

Group	Value	95% CI
Expiratory Muscle Strength Training	8.71	± 13.09

Post-training, boundaries unrelated to syntax

Group	Value	95% CI
Expiratory Muscle Strength Training	12.33	± 17.36

Telehealth Satisfaction Secondary · Post-Training (week 10)

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,

Group	Value	95% CI
Expiratory Muscle Strength Training	60.58	± 7.69

Change From Pre-Training to Post-Training in Communication Participation Item Bank Secondary · Pre-Training (week 3) and Post-Training (week 10)

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.

pre-training (week 3)

Group	Value	95% CI
Expiratory Muscle Strength Training	47.78	± 15.96

post-training (week 10)

Group	Value	95% CI
Expiratory Muscle Strength Training	48.51	± 14.65

Change From Baseline to Post-Treatment in ALS Quality of Life Scale Secondary · Baseline 1 (week 1) and Post-Training (week 10)

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 complet

pre-training

Group	Value	95% CI
Expiratory Muscle Strength Training	5.97	± 0.99

post-training

Group	Value	95% CI
Expiratory Muscle Strength Training	5.94	± 0.94

ALS Function Rating Scale Revised Secondary · Baseline 1 (week 1) and Post-Training (week 10)

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.

Baseline (week 1)

Group	Value	95% CI
Expiratory Muscle Strength Training	39	36 – 47

Post-training (week 10)

Group	Value	95% CI
Expiratory Muscle Strength Training	37	30 – 47

Psychosocial Impact of Assistive Devices Scale Secondary · Post-treatment (week 10)

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).

Group	Value	95% CI
Expiratory Muscle Strength Training	28.08	± 26.61

Tele-health Session Attendance Secondary · Measured at the end of training across the entire training period

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

Group	Value	95% CI
Expiratory Muscle Strength Training	95.37	± 7.43

Adherence to Training Protocol Secondary · Measured each week of training across the entire training duration

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

Group	Value	95% CI
Expiratory Muscle Strength Training	90.65	± 16.94

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.