Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's Disease) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
ADELA Gipuzkoa
RECRUITING
Donostia / San Sebastian
Contact Information
Primary
Jordi Vilaró, Professor
jordi.gestos@gmail.com
+34666580946
Backup
Nora Saez, Research coordinator
nora.saez@hotmail.com
+34 680 38 35 33
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 44
Treatments
Experimental: Intervention group
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.
Sham_comparator: Control group
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.
Sponsors
Leads: University Ramon Llull

This content was sourced from clinicaltrials.gov