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Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis

RecruitingNAAges 20 Years - anyAllNational Center of Neurology and Psychiatry, Japan
NCT07257302 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to determine whether lung insufflation capacity (LIC) training can help maintain respiratory function and prolong tracheostomy-free survival in people with amyotrophic lateral sclerosis (ALS). The main questions are: Does early and continuous LIC training slow the decline in forced vital capacity (FVC)? Does LIC training prolong the time to tracheostomy or death? This single-center study at the National Center of Neurology and Psychiatry (NCNP) in Japan will enroll 25 adults with ALS diagnosed according to the El Escorial or Awaji criteria. This is a single-arm study with no concurrently enrolled control group. Comparative analyses will use matched external controls. PRO-ACT will be used primarily to evaluate short-term respiratory-function trajectories, while JACALS, if data access is approved, will be used primarily to evaluate long-term time-to-ev

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 20 years or older * Diagnosis of amyotrophic lateral sclerosis (ALS) according to the El Escorial or Awaji criteria * Not using noninvasive ventilation (NIV) and without tracheostomy at the start of LIC training * Able to perform study assessments and provide written informed consent (or assisted signature with communication aid) Exclusion Criteria: * Chronic pulmonary disease other than ALS (e.g., COPD, interstitial lung disease) * Severe cognitive or communication impairment preventing study participation * Uncontrolled cardiovascular disease, including unstable angina, recent myocardial infarction, decompensated heart failure, serious arrhythmia, severe aortic stenosis, or active myocarditis/endocarditis * Uncontrolled hypertension * Acute systemic illness or fever * Recent pulmonary embolism, acute cor pulmonale, or severe pulmonary hypertension * Severe hepatic or renal dysfunction * Any condition judged inappropriate by the investigator
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What it tests

  • LIC Trainer (Lung Insufflation Capacity Trainer)
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Where

1 site
National Center of Neurology and Psychiatry (NCNP)
Kodaira, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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