Clinical trial NCT05003167: Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Official title: Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-08-12
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants enrolled will receive the intervention.
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change From Baseline to Post-treatment for Maximum Expiratory Pressure
timeFrame: Baseline 2 (week 2), Pre-Training (week 3), and Post-Training (week 10)
Secondary outcomes:
measure: Peak Expiratory Flow Rate
timeFrame: Baseline 2 (week 2), Pre-training (week 3), Post-Training (week 10)
measure: Change From Baseline to Post-Treatment in Utterance Length
timeFrame: Baseline 1 (week 1) and Post-Training (week 10)
measure: Change From Baseline to Post-Treatment in Number of Pauses
timeFrame: Baseline 1 (week 1) and Post-Training (week 10)
measure: Change From Baseline to Post-Treatment in Syntactic Location of Pauses
timeFrame: Baseline 1 (week 1) and Post-Training (week 10)
measure: Telehealth Satisfaction
timeFrame: Post-Training (week 10)
measure: Change From Pre-Training to Post-Training in Communication Participation Item Bank
timeFrame: Pre-Training (week 3) and Post-Training (week 10)
measure: Change From Baseline to Post-Treatment in ALS Quality of Life Scale
timeFrame: Baseline 1 (week 1) and Post-Training (week 10)
measure: ALS Function Rating Scale Revised
timeFrame: Baseline 1 (week 1) and Post-Training (week 10)
measure: Psychosocial Impact of Assistive Devices Scale
timeFrame: Post-treatment (week 10)
measure: Tele-health Session Attendance
timeFrame: Measured at the end of training across the entire training period
measure: Adherence to Training Protocol
timeFrame: Measured each week of training across the entire training duration
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Jessica E Huber, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: