Inspiratory muscle training for people with ALS

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University Ramon Llull (other)
• Locations: 1 site (Donostia / San Sebastian, Gipuzka)
• Trial ID: NCT07413718 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Small prior studies of inspiratory muscle training in neuromuscular disease and ALS have shown mixed or preliminary benefits but results are not yet definitive.

Eligibility 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 this trial is running

Donostia / San Sebastian, Gipuzka

• ADELA Gipuzkoa — Donostia / San Sebastian, Gipuzka, Spain (RECRUITING)

Study contacts

• Study coordinator: Jordi Vilaró, Professor

Conditions: Amyotrophic Lateral Slerosis, Pulmonary function, Respiratory muscles, Inspiratory Muscle Training, Respiratory preassure