Amyotrophic Lateral SlerosisIMT4LASNCT07413718
Inspiratory Muscle Training in Amiotrophyc Lateral Sclerosis
A study testing Inspiratory muscle training in people with Amyotrophic Lateral Slerosis, run by University Ramon Llull at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Amyotrophic Lateral Slerosis
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
ADELA Gipuzkoa
Donostia / San Sebastian, Gipuzka, 20015
About this study
Official title: 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.
Read the 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.
- Conditions
- Amyotrophic Lateral Slerosis
- Being tested
- Inspiratory muscle training, Sham training
- Keywords
- Amyotrophic Lateral Slerosis, Pulmonary function, Respiratory muscles, Inspiratory Muscle Training, Respiratory preassure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
Also called IMT
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.
Sham trainingDevice
Also called Placebo 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: Inspiratory muscle training |
| Control group | Sham comparator | 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. Receives: Device: Sham training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle preassure: MIP
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.
Measured: 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 outcomes (5)
Maximal Expiratory Pressure: MEP
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SlerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ramon Llull
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Vilaró Casamitjana, University Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413718
- Sponsor's protocol ID
- 2025-ELA
- Acronym
- IMT4LAS
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inspiratory Muscle Training in Patients With Amyotrophic Lateral Sclerosis: A Clinical Trial
- ClinicalTrials.gov ID
- NCT07413718
- Acronym / sponsor ID
- IMT4LAS / 2025-ELA
- Conditions
- Amyotrophic Lateral Slerosis
- Keywords
- Amyotrophic Lateral Slerosis, Pulmonary function, Respiratory muscles, Inspiratory Muscle Training, Respiratory preassure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Ramon LlullUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Inspiratory muscle trainingThe 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. |
| Control group | Sham comparator | Device: Sham trainingThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingAlso: IMTTraining 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. | Device | Intervention group |
| Sham trainingAlso: Placebo trainingFollow 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. | Device | Control group |
Primary outcome
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.
5 secondary outcomes
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
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Amyotrophic Lateral Slerosis, run by University Ramon Llull at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordi Vilaró, Professor (+34666580946, jordi.gestos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.