Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05003167
• Other study ID #: IRB-2020-524
• Secondary ID: 1F31DC019281-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2023
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 weeks.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

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).

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline 2 (week 2), Pre-training (week 3), Post-Training (week 10)
Secondary	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.	Baseline 1 (week 1) and Post-Training (week 10)
Secondary	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.	Baseline 1 (week 1) and Post-Training (week 10)
Secondary	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.	Baseline 1 (week 1) and Post-Training (week 10)
Secondary	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.	Post-Training (week 10)
Secondary	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.	Pre-Training (week 3) and Post-Training (week 10)
Secondary	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.	Baseline 1 (week 1) and Post-Training (week 10)
Secondary	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.	Baseline 1 (week 1) and Post-Training (week 10)
Secondary	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).	Post-treatment (week 10)
Secondary	Tele-health Session Attendance	% of training sessions scheduled and attended by participants throughout the study duration	Measured at the end of training across the entire training period
Secondary	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 each week of training across the entire training duration