Inspiratory muscle training for people with ALS
Official title: Efficacy of Inspiratory Muscle Training in Patients With Amyotrophic Lateral Sclerosis: A Clinical Trial
Run by University Ramon Llull · NCT07413718 · Data updated 2026-11-12
This program will try a 12-week inspiratory muscle training device versus a sham device to strengthen breathing muscles in people with early ALS.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | University Ramon Llull Academic / other |
| Locations | 1 site (Donostia / San Sebastian, Gipuzka) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07413718 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with spinal ALS diagnosed less than two years ago who have preserved lung function (FVC ≥ 80%, FEV1 ≥ 80%, FEV1/FVC ≥ 80%) and normal inspiratory pressure measures.
✕Probably not a fit
Patients with existing respiratory muscle weakness, nocturnal hypoventilation, inability to perform the breathing tests or exercises, or other contraindications are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, double-blind, sham-controlled multicenter trial enrolling 44 people with spinal ALS diagnosed within the past two years. Participants are randomized 1:1 to a 12-week inspiratory muscle training (IMT) program using a resistive device or to a sham training regimen. Eligible participants must have preserved lung function and no signs of respiratory muscle weakness at baseline, and assessments will include respiratory pressures and pulmonary function measures. The trial aims to see whether targeted IMT can slow loss of inspiratory muscle strength and help preserve respiratory function.
Why it matters
Potential benefit: If successful, this approach could help people with early ALS maintain breathing muscle strength longer, preserve lung function, improve comfort and quality of life, and potentially delay respiratory complications.
How similar studies have gone: Small prior studies of inspiratory muscle training in neuromuscular disease and ALS have shown mixed or preliminary benefits but results are not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
ADELA Gipuzkoa
Donostia / San Sebastian, Gipuzka, Spain Recruiting
Study contacts
- Study coordinator: Jordi Vilaró, Professor
- Email: jordi.gestos@gmail.com
- Phone: +34666580946
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.