Clinical Trial: Exploratory study on the effects of lung insufflation capacity training in patients with amyotrophic lateral sclerosis: a single-center prospective interventional study (Japan)

Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059315) titled 'Exploratory study on the effects of lung insufflation capacity training in patients with amyotrophic lateral sclerosis: a single-center prospective interventional study' on Oct. 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - National Center of Neurology and Psychiatry

Condition: Condition - Amyotrophic lateral sclerosis (ALS) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate whether continuous lung volume recruitment therapy using a lung insufflation capacity trainer, initiated before the onset of respiratory symptoms, can slow the decline in respiratory function and improve survival in patients with amyotrophic lateral sclerosis (ALS). Basic objectives2 - Others

Intervention: Interventions/Control_1 - Lung volume recruitment therapy (LVRT) will be performed using the Lung Insufflation Capacity Trainer 2 (LIC Trainer). With a mask sealed over the nose and mouth, air is insufflated through a connected bag-valve-mask until the subject reaches the maximum tolerable inspiratory volume (about 500 mL per compression, repeated consecutively). The subject then exhales through the release valve. Each session includes about 10 insufflation cycles, performed twice daily. Follow-up and retraining are conducted every 3 months. The intervention period is up to 3 years.

Eligibility: Age-lower limit - 20 years-old 20 years at the time of consent Diagnosed with amyotrophic lateral sclerosis (ALS) according to the El Escorial or Awaji criteria, and under treatment at the National Center of Neurology and Psychiatry Not using non-invasive ventilation (NIV) or tracheostomy at the time of LVRT initiation Key exclusion criteria - Presence of chronic respiratory diseases other than ALS (e.g., COPD or interstitial pneumonia) Severe cognitive impairment or communication difficulty making intervention infeasible Inability to obtain written informed consent from the participant or their proxy Severe cardiac disease (e.g., unstable angina, recent myocardial infarction, decompensated heart failure, uncontrolled arrhythmia) Uncontrolled hypertension or acute systemic illness Recent pulmonary embolism, acute cor pulmonale, or severe pulmonary hypertension Severe hepatic or renal dysfunction Other conditions deemed inappropriate by the principal investigator Target Size - 15

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 10 Month 03 Day Date of IRB - 2025 Year 10 Month 07 Day Anticipated trial start date - 2025 Year 10 Month 07 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067849

Disclaimer: Curated by HT Syndication.