Inspiratory Muscle Training in Amiotrophyc Lateral Sclerosis
Efficacy of Inspiratory Muscle Training in Patients With Amyotrophic Lateral Sclerosis: A Clinical Trial
University Ramon Llull
44 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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.
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07413718