Trial Outcomes & Findings for Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS (NCT NCT05003167)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

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

Results posted on

2023-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	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). 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).
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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). 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).
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Expiratory Muscle Strength Training n=13 Participants 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 (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).
Age, Continuous	59.46 years STANDARD_DEVIATION 8.63 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
ALSFRS-R baseline	38.8 units on a scale STANDARD_DEVIATION 3.75 • n=5 Participants
Montreal Cognitive Assessment baseline	28.23 units on a scale STANDARD_DEVIATION 1.42 • n=5 Participants

PRIMARY outcome

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

Population: All participants with baseline, pre-training, and post-treatment maximum expiratory pressure values were included. The second baseline and pre-training values were averaged to obtain the pre-training value which was used along with the week 10 value (post-treatment).

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

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Change From Baseline to Post-treatment for Maximum Expiratory Pressure Pre-training average	66.10 cmH2O Standard Deviation 41.77
Change From Baseline to Post-treatment for Maximum Expiratory Pressure Post-training (week 10)	83.75 cmH2O Standard Deviation 45.99

SECONDARY outcome

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

Population: All participants with baseline 2 (week 2) and pre-training values (week 3) and post-training (week 10) data were included.

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.

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Peak Expiratory Flow Rate Pre-training average	265.97 liters per minute Standard Deviation 141.47
Peak Expiratory Flow Rate Post-training (week 10)	273.47 liters per minute Standard Deviation 127.69

SECONDARY outcome

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

Population: All participants who had baseline and post-training values for this measure. Data from the first baseline and the week 10 post-treatment value were used.

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.

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Change From Baseline to Post-Treatment in Utterance Length Baseline (reading) - week 1	10.76 syllables Standard Deviation 3.29
Change From Baseline to Post-Treatment in Utterance Length Post-training (reading) - week 10	10.39 syllables Standard Deviation 4.11

SECONDARY outcome

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

Population: All participants with baseline and post-training values. Data from the first baseline and the week 10 post-treatment value were used.

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

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Change From Baseline to Post-Treatment in Number of Pauses Baseline (reading) - week 1	15.89 number of pauses Standard Deviation 8.28
Change From Baseline to Post-Treatment in Number of Pauses Post-training (reading) - week 10	16.75 number of pauses Standard Deviation 10.99

SECONDARY outcome

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

Population: All participants with baseline and post-training values. Data from baseline (week 1) and post-training (week 10) were used.

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.

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Change From Baseline to Post-Treatment in Syntactic Location of Pauses Baseline, major boundaries	47.12 percent of pauses at the boundary Standard Deviation 37.59
Change From Baseline to Post-Treatment in Syntactic Location of Pauses Post-training, major boundaries	46.09 percent of pauses at the boundary Standard Deviation 18.92
Change From Baseline to Post-Treatment in Syntactic Location of Pauses Baseline, boundaries unrelated to syntax	8.71 percent of pauses at the boundary Standard Deviation 13.09
Change From Baseline to Post-Treatment in Syntactic Location of Pauses Post-training, boundaries unrelated to syntax	12.33 percent of pauses at the boundary Standard Deviation 17.36

SECONDARY outcome

Timeframe: Post-Training (week 10)

Population: Only assessed at post-training. Included all participants who completed the scale. Higher values reflect more satisfaction and the score maximum is 75.

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.

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Telehealth Satisfaction	60.58 score on a scale Standard Deviation 7.69

SECONDARY outcome

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

Population: All participants with pre- and post-training scores. Data from the pre-training in week 3 and the week 10 post-treatment value were used.

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.

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Change From Pre-Training to Post-Training in Communication Participation Item Bank post-training (week 10)	48.51 T-score scale points Standard Deviation 14.65
Change From Pre-Training to Post-Training in Communication Participation Item Bank pre-training (week 3)	47.78 T-score scale points Standard Deviation 15.96

SECONDARY outcome

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

Population: All participants with pre- and post-training scores on the scale. Lower scores reflect less effect of ALS on quality of life.

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.

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Change From Baseline to Post-Treatment in ALS Quality of Life Scale pre-training	5.97 units on a scale Standard Deviation 0.99
Change From Baseline to Post-Treatment in ALS Quality of Life Scale post-training	5.94 units on a scale Standard Deviation 0.94

SECONDARY outcome

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

Population: All participants with baseline (week 1) and post-training (week 10) scores were included.

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.

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
ALS Function Rating Scale Revised Post-training (week 10)	37 score on a scale Interval 30.0 to 47.0
ALS Function Rating Scale Revised Baseline (week 1)	39 score on a scale Interval 36.0 to 47.0

SECONDARY outcome

Timeframe: Post-treatment (week 10)

Population: All participants with a post-treatment (week 10) score.

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).

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Psychosocial Impact of Assistive Devices Scale	28.08 score on a scale Standard Deviation 26.61

SECONDARY outcome

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

Population: Participants who completed the training protocol

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

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Tele-health Session Attendance	95.37 percentage of sessions attended Standard Deviation 7.43

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Expiratory Muscle Strength Training n=12 Participants 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 (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).
Adherence to Training Protocol	90.65 percent of at-home training completed Standard Deviation 16.94

Adverse Events

Expiratory Muscle Strength Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica Huber, Professor and PI

Purdue University

Phone: 765-494-3796

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place