N/A N=9 Supportive Care

Respiratory Muscle Training (RMT) in ALS

ALS

Bottom Line

View on ClinicalTrials.gov: NCT04224961 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Jan 2026

Primary outcome: Primary: Number of Participants With Safe, Well-tolerated Moderate Intensity Respiratory Muscle Training (RMT) as Measured by Rating of Perceived Exertion (RPE) — 4 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Respiratory Muscle Training (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Safe, Well-tolerated Moderate Intensity Respiratory Muscle Training (RMT) as Measured by Rating of Perceived Exertion (RPE)	4	—
PRIMARY Number of Participants With Safe, Well-tolerated Moderate Intensity Respiratory Muscle Training (RMT) as Measured by Pain Score	6	—
PRIMARY Number of Participants Able to Complete Respiratory Muscle Training (RMT)	7; 0	—
PRIMARY Magnitude of Change in Maximum Inspiratory Pressure From Pre-test to Post-test as Determined by Cohen's Measure of Effect Size	5; 1; 1	—
PRIMARY Magnitude of Change in Maximum Expiratory Pressure From Baseline to Withdrawal as Determined by Cohen's Measure of Effect Size	5; 2	—
SECONDARY Change in Peak Cough Flow in L/Min	—	—
SECONDARY Change in Sniff Nasal Inspiratory Pressure	—	—

Summary

Twelve adults with ALS will participate in a study involving four 3-week cycles of progressive respiratory muscle training (RMT). The investigators will measure maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) weekly. The investigators will obtain the majority of measurements of MIP and MEP during web-based telehealth visits. Participants will be stratified into 2 groups based on baseline inspiratory muscle strength as determined by maximum inspiratory pressure (MIP): six participants with minimal to no respiratory weakness (i.e., MIP ≥ 70% predicted) and six participants with mild to moderate inspiratory weakness (i.e., MIP 40-70% predicted).

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years
Confirmed diagnosis of ALS
Ability to follow directions for study participation
Ability to successfully and independently complete RMT repetitions at a minimum pressure-threshold target equal to 30% of MIP or MEP
Ability to complete telehealth visits using a smartphone or computer with video capabilities
Ability to complete a home-RMT regimen

Exclusion Criteria

MIP < 40 cmH20
Presence of a tracheostomy
Use of non-invasive or invasive ventilation when awake
Participant or caregiver(s) inability to manipulate respiratory pressure meter, the RMT device, or calibration equipment for home training
Inability to complete RMT repetitions successfully
Concomitant neurologic or neurodegenerative conditions (e.g. stroke, dementia) or other serious conditions that would prevent meaningful study participation as determined at the discretion of the principal investigator
Inability to give legally effective consent
Inability to read and understand English

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04224961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.