UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059315 |
|---|---|
| Receipt number | R000067849 |
| Scientific Title | Exploratory study on the effects of lung insufflation capacity training in patients with amyotrophic lateral sclerosis: a single-center prospective interventional study |
| Date of disclosure of the study information | 2025/10/07 |
| Last modified on | 2025/10/07 15:19:05 |
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Basic information
Public title
Exploratory study on the effects of lung insufflation capacity training in patients with amyotrophic lateral sclerosis: a single-center prospective interventional study
Acronym
LIC Training ALS Study
Scientific Title
Exploratory study on the effects of lung insufflation capacity training in patients with amyotrophic lateral sclerosis: a single-center prospective interventional study
Scientific Title:Acronym
ALS-LIC study
Region
| Japan |
Condition
Condition
Amyotrophic lateral sclerosis (ALS)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
To explore the clinical efficacy of respiratory rehabilitation using lung insufflation capacity training.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
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 sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Taiyo |
| Middle name | |
| Last name | Kawaguchi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Physical Rehabilitation, Hospital
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
042-341-2712
t.kawaguchi123@keio.jp
Public contact
Name of contact person
| 1st name | Taiyo |
| Middle name | |
| Last name | Kawaguchi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Physical Rehabilitation, Hospital
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
042-341-2712
Homepage URL
t.kawaguchi123@keio.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
Tel
042-341-2712
ncnp_rinri@ncnp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立研究開発法人国立精神・神経医療研究センター病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067849
