Respiratory Muscle Training (RMT) in ALS

NCT04224961 | Completed Results FDA Device

• 1 other identifier: Pro00103777
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

ALS

Outcome Measures

Primary Outcomes (5)

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

  Safe, well-tolerated moderate intensity Respiratory Muscle Training (RMT) is in part defined as an RPE between 4-5 and \<6. The RPE is a way of measuring physical activity intensity level. Perceived exertion is how hard the participant feels like their body is working. 0 = rest, 1 = very easy, 2 = easy, 3 = moderate, 4 = somewhat hard, 5 = hard, 6 = harder, 7 = very hard, 8/9 = extremely hard, 10 = maximal.

  12 weeks

• Number of Participants With Safe, Well-tolerated Moderate Intensity Respiratory Muscle Training (RMT) as Measured by Pain Score

  Safe, well-tolerated moderate intensity Respiratory Muscle Training (RMT) is in part defined as a pain rating of \<4 on a standard 0-10 scale, where 0 = no pain and 10 = the worst pain possible.

  12 weeks

• Number of Participants Able to Complete Respiratory Muscle Training (RMT)

  Feasibility will be determined by the number of participants able to complete the Respiratory Muscle Training

  12 weeks

• Magnitude of Change in Maximum Inspiratory Pressure From Pre-test to Post-test as Determined by Cohen's Measure of Effect Size

  Magnitude of change for our primary outcome measures will be determined using Cohen's measure of effect size (d) as defined by the first equation for single-subject d provided by Busk and Serlin (1992). Simply stated, d is obtained by subtracting the mean of the first assessment from the mean of the second assessment, divided by the standard deviation of the first assessment. Effect size calculations will be determined to compare results from pre-test (M7) to post-test (M18). The investigators will use conservative interpretation guidelines for effect size calculations in which d \< 0.6 is negligible, d ≥ 0.6 modest, d ≥ 1.0 large, and d ≥ 2.0 very large.

  from pre-test (week 7) to post-test (week 18)

• Magnitude of Change in Maximum Expiratory Pressure From Baseline to Withdrawal as Determined by Cohen's Measure of Effect Size

  Magnitude of change for our primary outcome measures will be determined using Cohen's measure of effect size (d) as defined by the first equation for single-subject d provided by Busk and Serlin (1992). Simply stated, d is obtained by subtracting the mean of the first assessment from the mean of the second assessment, divided by the standard deviation of the first assessment. Effect size calculations will be determined to compare results from baseline (M0-M5) to withdrawal (M19-M24). The investigators will use conservative interpretation guidelines for effect size calculations in which d \< 0.6 is negligible, d ≥ 0.6 modest, d ≥ 1.0 large, and d ≥ 2.0 very large.

  from baseline to withdrawal (up to week 24)

Secondary Outcomes (2)

• Change in Peak Cough Flow in L/Min

  Baseline, 7 weeks, 18 weeks, 24 weeks

• Change in Sniff Nasal Inspiratory Pressure

  Baseline, 7 weeks, 18 weeks, 24 weeks

Study Arms (2)

Minimal to No Respiratory Weakness

EXPERIMENTAL

MIP ≥ 70% predicted Complete home-based RMT program and participate in weekly web-based RMT therapy sessions.

Device: Respiratory Muscle Training

Mild to Moderate Inspiratory Weakness

EXPERIMENTAL

MIP 40-70% predicted Complete home-based RMT program and participate in weekly web-based RMT therapy sessions.

Device: Respiratory Muscle Training

Interventions

Respiratory Muscle Training DEVICE

Two commercially available pressure-threshold RMT devices that utilize a spring-loaded flange to provide resistance against inspiration and expiration independent of respiratory flow rate will be used to provide the necessary range of resistance. Each participant will use two RMT devices, one for IMT and one for EMT.

Also known as: EMST 150, Threshold IMT

Mild to Moderate Inspiratory Weakness; Minimal to No Respiratory Weakness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Harrison N. Jones, PhD
• Organization: Duke University

harrison.jones@duke.edu

919-681-1852

Study Officials

• Harrison Jones, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: January 14, 2020
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)