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RECRUITINGINTERVENTIONAL

Inspiratory Muscle Training in Amiotrophyc Lateral Sclerosis

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Inspiratory muscle training

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.

DEVICE

Sham 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.

Locations (1)

ADELA Gipuzkoa
Donostia / San Sebastian, Gipuzka, Spain