[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624752":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":45,"responsibleParty":60,"collaborators":34,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":34,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":48,"whyStopped":34,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University Ramon Llull","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","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.",[13],"Device: Inspiratory muscle training",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","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.",[19],"Device: Sham training",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],[27],"IMT",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"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.",[15],[33],"Placebo training",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Jordi Vilaró, Professor","CONTACT","+34666580946","jordi.gestos@gmail.com",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},"Nora Saez, Research coordinator","+34 680 38 35 33","nora.saez@hotmail.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":34},"ADELA Gipuzkoa","RECRUITING","Donostia \u002F San Sebastian","Gipuzka","20015","Spain","ES",{"type":55,"coordinates":56},"Point",[57,58],-1.97499,43.31283,{"lat":58,"lon":57},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Jordi Vilaró Casamitjana","Professor","100624752","inspiratory-muscle-training-in-amiotrophyc-lateral-sclerosis-100624752",false,"NCT07413718","Inspiratory Muscle Training in Amiotrophyc Lateral Sclerosis","Efficacy of Inspiratory Muscle Training in Patients With Amyotrophic Lateral Sclerosis: A Clinical Trial","IMT4LAS","Inclusion Criteria:\n\n* Patients diagnosed with spinal ALS\n* men and women\n* diagnosis date less than two years ago, according to the \"El Escorial\" criteria (Appendix 2)\n* PIM above the lower limit of normal\n* Preserved lung function (FVC ≥ 80%, FEV1 ≥ 80%, FEV1\u002FFVC ≥ 80%) and normal values in supine position\n\nExclusion Criteria:\n\n* Patients with signs of respiratory muscle weakness (MIP and MEP below the LLN and abnormal decubitus tests19-21)\n* Nocturnal hypoventilation\n* Inability to perform the measurement tests\n* Inability to understand and perform the exercises\n* Any contraindication to the use of IMT. Severe psychiatric illness.","ALL","18 Years","85 Years",{"count":76,"type":77},44,"ESTIMATED","INTERVENTIONAL",[80],"NA","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.\n\nThe 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.",[83],"Amyotrophic Lateral Slerosis",[83,85,86,87,88],"Pulmonary function","Respiratory muscles","Inspiratory Muscle Training","Respiratory preassure","2026-02-12",{"date":91,"type":92},"2026-02-17","ACTUAL",{"date":94,"type":92},"2025-09-01",{"date":96,"type":77},"2026-12-31",{"name":5,"class":6},1]