Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:38 AM
Study NCT ID:
NCT07413718
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inspiratory Muscle Training in Amiotrophyc Lateral Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "To ensure participant blinding, both groups will use the same training device. In the control group, the device will be modified to simulate a resistance of 5 cmH₂O (less than 5% of Maximal Inspiratory Pressure), a level that does not produce any physiological training effect. The investigator supervising the intervention will not inform participants of their group assignment at any time.\n\nTo ensure blinding of outcome measurements, a separate investigator from the research team-who will not know participants' group allocation-will conduct all evaluations.\n\nFinally, the statistician responsible for data analysis will also be blinded to group assignment. The study database will include only coded numerical identifiers, preventing identification of the intervention or control groups. Once statistical analyses are completed, results will be returned to the principal investigator, who will then unblind the data to identify which results correspond to each group."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inspiratory muscle preassure: MIP', 'timeFrame': 'Baseline: Initial evaluation before the intervention. During intervention: Assessments at months 1, 2, and 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.', 'description': 'We follow the ATS/ERS recommended protocol. From a sitting position, the patient performs a full expiration to reach residual volume. Using a mouthpiece connected to a manometer, the patient is then instructed to perform a maximal inspiration and hold it for at least 3 seconds. This measurement will be repeated at least three times to ensure a minimal difference of ≤5% between attempts.'}], 'secondaryOutcomes': [{'measure': 'Maximal Expiratory Pressure: MEP', 'timeFrame': 'Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effect', 'description': 'We follow the ATS/ERS recommended protocol. From a sitting position, the patient performs a full inspiration to reach total lung capacity. Using a mouthpiece connected to a manometer, the patient is then instructed to perform a maximal expiration and hold it for at least 3 seconds. This measurement will be repeated at least three times to ensure a minimal difference of ≤5% between attempts.'}, {'measure': 'Quality of life: ALSAQ-40', 'timeFrame': 'Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.', 'description': 'The Spanish version of the ALSAQ-40 scale will be used. Each study participant will complete the questionnaire in a quiet environment, with the questions presented clearly to ensure they can be answered confidently and without hesitation.'}, {'measure': 'Forced espirometry', 'timeFrame': 'Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.', 'description': 'We follow the ATS/ERS recommended protocol in siiting and supine position. Patient will be encourage to do a maximal and forced expiration followed by a deep inspiration. This measurement will be reapited at least 3 times to ensure a minimal difference of 5% inbetween. Expiratory flow and volumen variables will be taked.'}, {'measure': 'Functional assessment: ALSFRS-R', 'timeFrame': 'Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.', 'description': 'ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) is a questionnaire used to assess the physical function of patients with Amyotrophic Lateral Sclerosis (ALS), measuring 12 aspects such as swallowing, speaking, walking or breathing. Each aspect is scored from 0 (no ability) to 4 (normal), adding up to a total of 48 points, which allows monitoring the progression of the disease.'}, {'measure': 'Nocturnal pulse oximetry', 'timeFrame': 'Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.', 'description': 'The patient will be given the device and instructed on how to wear it to sleep with it all night. Reference values will be POX, mean SatO2, CT90, and CT85.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyotrophic Lateral Slerosis', 'Pulmonary function', 'Respiratory muscles', 'Inspiratory Muscle Training', 'Respiratory preassure'], 'conditions': ['Amyotrophic Lateral Slerosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Amyotrophic Lateral Sclerosis (ALS) is a progressive disease that damages the nerve cells responsible for voluntary muscle movement. Over time, this leads to weakness in the muscles used for movement, speech, swallowing, and 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\nMaintaining the strength of these muscles for as long as possible is very important. Specific breathing exercises, known as inspiratory muscle training, can help strengthen these muscles by making them work against a gentle resistance when breathing in. This may help people with ALS maintain their breathing capacity longer, improve comfort and quality of life, and possibly extend survival time.\n\nThis study is a prospective, controlled, randomised, double-blind, masked, multicentre clinical trial that will include 44 people diagnosed with ALS who have lived with the disease for less than two years. It will take place in several hospitals and research centres.\n\nParticipants will be randomly divided into two groups:\n\nExperimental group (22 participants): They will follow a 12-week inspiratory muscle training programme using a device that provides resistance when breathing in. This means the muscles have to work harder, much like resistance training for other parts of the body.\n\nControl group (22 participants): They will use the same device for the same period, but with a placebo valve that allows air to pass freely, providing no resistance.\n\nNeither the participants nor the researchers who assess the results will know which group each person belongs to. This "double-blind" design ensures that any differences observed between the groups are due to the intervention itself and not to expectations or bias.\n\nThe main objective of the study is to find out whether inspiratory muscle resistance training helps people with ALS maintain their Maximal Inspiratory Pressure (MIP)-a measure of the strength of the breathing muscles-for a longer time compared to those who do not train with resistance.\n\nThe secondary objectives include evaluating whether this training improves tolerance to daily activities, enhances well-being and comfort in breathing, and contributes to better overall quality of life.\n\nAll participants will continue to receive their usual medical care for ALS. The breathing training is an additional, supervised activity designed to support respiratory health. Every participant will be closely monitored by a team of healthcare professionals throughout the study to ensure safety and proper follow-up.\n\nBy joining this research, patients and families are helping to improve scientific understanding of ALS and to identify non-drug interventions that may help maintain function and independence for longer. The results will contribute to the development of new recommendations for respiratory care and rehabilitation in people living with ALS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/FVC ≥ 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.'}, 'identificationModule': {'nctId': 'NCT07413718', 'acronym': 'IMT4LAS', 'briefTitle': 'Inspiratory Muscle Training in Amiotrophyc Lateral Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University Ramon Llull'}, 'officialTitle': 'Efficacy of Inspiratory Muscle Training in Patients With Amyotrophic Lateral Sclerosis: A Clinical Trial', 'orgStudyIdInfo': {'id': '2025-ELA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '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.', 'interventionNames': ['Device: Inspiratory muscle training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': '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.', 'interventionNames': ['Device: Sham training']}], 'interventions': [{'name': 'Inspiratory muscle training', 'type': 'DEVICE', 'otherNames': ['IMT'], 'description': '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.', 'armGroupLabels': ['Intervention group']}, {'name': 'Sham training', 'type': 'DEVICE', 'otherNames': ['Placebo training'], 'description': '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.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20015', 'city': 'Donostia / San Sebastian', 'state': 'Gipuzka', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'ADELA Gipuzkoa', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}], 'centralContacts': [{'name': 'Jordi Vilaró, Professor', 'role': 'CONTACT', 'email': 'jordi.gestos@gmail.com', 'phone': '+34666580946'}, {'name': 'Nora Saez, Research coordinator', 'role': 'CONTACT', 'email': 'nora.saez@hotmail.com', 'phone': '+34 680 38 35 33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ramon Llull', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jordi Vilaró Casamitjana', 'investigatorAffiliation': 'University Ramon Llull'}}}}