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

Exploratory study on the effects of lung insufflation capacity training in patients with amyotrophic lateral sclerosis: a single-center prospective interventional study - ALS-LIC study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059315

Enrollment

Registered

2025-10-07

Start date

2025-10-07

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis (ALS)

Interventions

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 connecte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Overall survival: The time from initiation of lung volume recruitment therapy to either tracheostomy or death, whichever occurs first, followed up until the end of the study or censoring date.	—

Secondary

Measure	Time frame
Longitudinal changes in respiratory function (%FVC, LIC, MIC, CPF, and assisted CPF) measured every 3 months Changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) scores over time Incidence and time to onset of respiratory infections or pneumonia	—

Countries

Japan

Contacts

Public ContactTaiyo Kawaguchi

National Center of Neurology and Psychiatry Department of Physical Rehabilitation, Hospital

t.kawaguchi123@keio.jp042-341-2712

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026