Inspiratory Muscle Training in Amiotrophyc Lateral Sclerosis (IMT4LAS)

February 12, 2026 updated by: Jordi Vilaró Casamitjana, University Ramon Llull

Efficacy of Inspiratory Muscle Training in Patients With Amyotrophic Lateral Sclerosis: A Clinical Trial

Amyotrophic Lateral Sclerosis (ALS) progressively damages the nerve cells responsible for voluntary muscle movement. Over time, this leads to weakness in different muscles such as those used for movement or breathing. Breathing problems are one of the main causes of complications and reduced survival in people with ALS. This happens because the inspiratory muscles-those that help draw air into the lungs-gradually lose strength.

The study has the aim to explore the benefits of training inspiratory muscles in ALS patients in order to maintain the setrength of these muscles for as long as possible and look the impact on respiratory function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Amyotrophic Lateral Sclerosis (ALS) is a progressive disease that damages the nerve cells responsible for voluntary muscle movement. Over time, this leads to weakness in the muscles used for movement, speech, swallowing, and breathing. Breathing problems are one of the main causes of complications and reduced survival in people with ALS. This happens because the inspiratory muscles-those that help draw air into the lungs-gradually lose strength.

Maintaining the strength of these muscles for as long as possible is very important. Specific breathing exercises, known as inspiratory muscle training, can help strengthen these muscles by making them work against a gentle resistance when breathing in. This may help people with ALS maintain their breathing capacity longer, improve comfort and quality of life, and possibly extend survival time.

This study is a prospective, controlled, randomised, double-blind, masked, multicentre clinical trial that will include 44 people diagnosed with ALS who have lived with the disease for less than two years. It will take place in several hospitals and research centres.

Participants will be randomly divided into two groups:

Experimental group (22 participants): They will follow a 12-week inspiratory muscle training programme using a device that provides resistance when breathing in. This means the muscles have to work harder, much like resistance training for other parts of the body.

Control group (22 participants): They will use the same device for the same period, but with a placebo valve that allows air to pass freely, providing no resistance.

Neither the participants nor the researchers who assess the results will know which group each person belongs to. This "double-blind" design ensures that any differences observed between the groups are due to the intervention itself and not to expectations or bias.

The main objective of the study is to find out whether inspiratory muscle resistance training helps people with ALS maintain their Maximal Inspiratory Pressure (MIP)-a measure of the strength of the breathing muscles-for a longer time compared to those who do not train with resistance.

The secondary objectives include evaluating whether this training improves tolerance to daily activities, enhances well-being and comfort in breathing, and contributes to better overall quality of life.

All participants will continue to receive their usual medical care for ALS. The breathing training is an additional, supervised activity designed to support respiratory health. Every participant will be closely monitored by a team of healthcare professionals throughout the study to ensure safety and proper follow-up.

By joining this research, patients and families are helping to improve scientific understanding of ALS and to identify non-drug interventions that may help maintain function and independence for longer. The results will contribute to the development of new recommendations for respiratory care and rehabilitation in people living with ALS.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Gipuzka
      • Donostia / San Sebastian, Gipuzka, Spain, 20015
        • Recruiting
        • ADELA Gipuzkoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The experimental group will include 22 ALS participants. Based on baseline Maximal Inspiratory Pressure (MIP) and supine tests, an individualized inspiratory muscle resistance training program will be prescribed.
Device: Inspiratory muscle training
Training will consist of resisted breathing exercises at 30% of MIP, twice daily for 12 weeks. MIP will be reassessed at 1 and 2 months to adjust the load. After 12 weeks, participants will continue the same exercises twice per week for 12 months at 40% of final MIP. All participants will also receive standard respiratory physiotherapy according to disease stage. Follow-up assessments will occur at 1, 2, 3, 6, and 12 months.
Other Names:
  • IMT
Sham Comparator: Control group
The control group will include 22 participants diagnosed with ALS. They will undergo the same baseline and follow-up assessments as the experimental group. Participants will receive their usual respiratory physiotherapy, which will be recorded throughout the study, and will perform the same inspiratory muscle training protocol but using a placebo device without the resistance valve, providing no inspiratory load. The follow-up schedule will be identical to the experimental group, with evaluations at 1, 2, 3, 6, and 12 months after the start of the intervention.
Device: Sham training
Follow a routine respiratory physiotherapy treatment (which will be recorded in the study) and an inspiratory muscle training protocol with a sham device; that is, it will not have the valve that imposes resistance.
Other Names:
  • Placebo training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspiratory muscle preassure: MIP
Time Frame: Baseline: Initial evaluation before the intervention. During intervention: Assessments at months 1, 2, and 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.
We follow the ATS/ERS recommended protocol. From a sitting position, the patient performs a full expiration to reach residual volume. Using a mouthpiece connected to a manometer, the patient is then instructed to perform a maximal inspiration and hold it for at least 3 seconds. This measurement will be repeated at least three times to ensure a minimal difference of ≤5% between attempts.
Baseline: Initial evaluation before the intervention. During intervention: Assessments at months 1, 2, and 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Expiratory Pressure: MEP
Time Frame: Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effect
We follow the ATS/ERS recommended protocol. From a sitting position, the patient performs a full inspiration to reach total lung capacity. Using a mouthpiece connected to a manometer, the patient is then instructed to perform a maximal expiration and hold it for at least 3 seconds. This measurement will be repeated at least three times to ensure a minimal difference of ≤5% between attempts.
Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effect
Quality of life: ALSAQ-40
Time Frame: Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.
The Spanish version of the ALSAQ-40 scale will be used. Each study participant will complete the questionnaire in a quiet environment, with the questions presented clearly to ensure they can be answered confidently and without hesitation.
Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.
Forced espirometry
Time Frame: Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.
We follow the ATS/ERS recommended protocol in siiting and supine position. Patient will be encourage to do a maximal and forced expiration followed by a deep inspiration. This measurement will be reapited at least 3 times to ensure a minimal difference of 5% inbetween. Expiratory flow and volumen variables will be taked.
Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.
Functional assessment: ALSFRS-R
Time Frame: Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) is a questionnaire used to assess the physical function of patients with Amyotrophic Lateral Sclerosis (ALS), measuring 12 aspects such as swallowing, speaking, walking or breathing. Each aspect is scored from 0 (no ability) to 4 (normal), adding up to a total of 48 points, which allows monitoring the progression of the disease.
Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.
Nocturnal pulse oximetry
Time Frame: Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.
The patient will be given the device and instructed on how to wear it to sleep with it all night. Reference values will be POX, mean SatO2, CT90, and CT85.
Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ramon Llull

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-ELA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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