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Can simple breathing exercises help ALS patients? small study says maybe

NCT ID NCT04224961

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a moderate-intensity breathing exercise program is safe and doable for people with ALS. Nine adults with ALS did four 3-week cycles of respiratory muscle training at home, with weekly check-ins via video call. The main goal was to see if participants could complete the exercises without pain or discomfort, and to measure changes in breathing strength.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Jan 2020

Finished

Nov 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALS

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.