Inspiratory Muscle Training in Amiotrophyc Lateral Sclerosis

NCT07413718 | Recruiting

• 1 other identifier: 2025-ELA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Amyotrophic Lateral Slerosis

Keywords

Amyotrophic Lateral Slerosis; Pulmonary function; Respiratory muscles; Inspiratory Muscle Training; Respiratory preassure

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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.

Study Arms (2)

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.

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.

Device: Sham training

Interventions

Inspiratory muscle training DEVICE

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.

Also known as: IMT

Intervention group

Sham training DEVICE

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.

Also known as: Placebo training

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ramon Llull: lead

Study Sites (1)

ADELA Gipuzkoa

Donostia / San Sebastian, Gipuzka, 20015, Spain

RECRUITING

Central Study Contacts

Jordi Vilaró, Professor

CONTACT

+34666580946; jordi.gestos@gmail.com

Nora Saez, Research coordinator

CONTACT

+34 680 38 35 33; nora.saez@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To ensure participant blinding, both groups will use the same training device. In the control group, the device will be modified to simulate a resistance of 5 cmH₂O (less than 5% of Maximal Inspiratory Pressure), a level that does not produce any physiological training effect. The investigator supervising the intervention will not inform participants of their group assignment at any time. To ensure blinding of outcome measurements, a separate investigator from the research team-who will not know participants' group allocation-will conduct all evaluations. Finally, the statistician responsible for data analysis will also be blinded to group assignment. The study database will include only coded numerical identifiers, preventing identification of the intervention or control groups. Once statistical analyses are completed, results will be returned to the principal investigator, who will then unblind the data to identify which results correspond to each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized control trial

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: February 17, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)