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Breathing training may slow muscle decline in ALS patients

NCT ID NCT07413718

Symptom relief Sponsor: University Ramon Llull Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a simple breathing exercise device can help people with ALS maintain the strength of their inspiratory muscles—the muscles that pull air into the lungs. Over 44 participants will do resisted breathing exercises twice daily for 12 weeks, then twice weekly for a year. The goal is to see if this training can slow respiratory decline and improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inspiratory muscle training (a breathing exercise device)
What this could lead to
If it works, this could help people with ALS keep their breathing muscles stronger for longer, potentially improving survival and quality of life.
What could go wrong
This is a small, early-stage trial with only 44 participants. The training may not slow breathing decline enough to make a real difference, and results may not apply to all ALS patients.

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

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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 to 85 years

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: * Patients diagnosed with spinal ALS * men and women * diagnosis date less than two years ago, according to the "El Escorial" criteria (Appendix 2) * PIM above the lower limit of normal * Preserved lung function (FVC ≥ 80%, FEV1 ≥ 80%, FEV1/FVC ≥ 80%) and normal values in supine position Exclusion Criteria: * Patients with signs of respiratory muscle weakness (MIP and MEP below the LLN and abnormal decubitus tests19-21) * Nocturnal hypoventilation * Inability to perform the measurement tests * Inability to understand and perform the exercises * Any contraindication to the use of IMT. Severe psychiatric illness.

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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.

Amyotrophic lateral slerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ADELA Gipuzkoa

    RECRUITING

    Donostia / San Sebastian, Gipuzka, 20015, Spain