UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062418 |
|---|---|
| Receipt number | R000071272 |
| Scientific Title | Feasibility of a novel airway clearance strategy using Mechanical Insufflation-Exsufflation in elderly patients with pneumonia: A pilot randomized controlled trial |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/07/31 13:02:00 |
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Basic information
Public title
Feasibility of a novel airway clearance strategy using Mechanical Insufflation-Exsufflation in elderly patients with pneumonia
Acronym
Feasibility of a novel airway clearance strategy using Mechanical Insufflation-Exsufflation in elderly patients with pneumonia
Scientific Title
Feasibility of a novel airway clearance strategy using Mechanical Insufflation-Exsufflation in elderly patients with pneumonia: A pilot randomized controlled trial
Scientific Title:Acronym
Feasibility of a novel airway clearance strategy using Mechanical Insufflation-Exsufflation in elderly patients with pneumonia: A pilot randomized controlled trial
Region
| Japan |
Condition
Condition
pneumonia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study on the feasibility and effectiveness of mechanical insufflation-exsufflation in older patientswith pneumonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility outcomes will include recruitment rate, adherence rate, and the occurrence of serious adverse events.
Key secondary outcomes
Collected data will include the presence or absence of sputum clearance, oxygen flow rate during the MI-E intervention period, frequency of suctioning, and SpO2 measured before, immediately after, and 10minutes after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention program will be initiated within 48 hours of hospitalization. In addition to MI-E, airway clearance techniques (including postural drainage and cough assistance) and an exercise program will be provided. The exercise will be adjusted according to the patient's general condition and physical functional level, starting with bed-based exercises and progressing stepwise to sitting, standing, and walking when feasible. In addition, strengthening exercises mainly targeting the lower limbs and trunk, as well as activities of daily living (ADL) training, will be performed 5-6 days per week. The discontinuation criteria for airway clearance techniques and MI-E will be comprehensively determined when one or more of the following conditions are met: (1) airway suctioning is no longer required; (2) adventitious lung sounds suggestive of airway secretions disappear; and (3) oxygenation status improves. The exercise program including early mobilization will be continued throughout the hospitalization period.
Interventions/Control_2
The control intervention will be initiated within 48 hours of hospital admission. The program will include airway clearance techniques (postural drainage and assisted coughing) and an exercise program incorporating early mobilization. The exercise program will be individualized according to each participant's general medical condition and physical function, beginning with bed-based exercises and progressing, when feasible, to sitting, standing, and ambulation. In addition, lower-extremity and trunk muscle strengthening exercises, as well as activities of daily living (ADL) training, will be provided 5-6 days per week. Airway clearance techniques will be discontinued based on an overall clinical assessment when one or more of the following criteria are met: (1) airway suctioning is no longer required; (2) adventitious lung sounds suggestive of retained airway secretions have resolved; and/or (3) oxygenation has improved. The exercise program, including early mobilization, will be continued throughout the hospitalization.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age sixty-five years or older. Diagnosis of pneumonia and prescription for rehabilitation within forty-eight hours of hospital admission.
2. Inadequate or absent sputum expectoration despite spontaneous coughing.
3. Requirement for tracheal suctioning.
Key exclusion criteria
1. Current or prior pneumothorax, or chronic respiratory disease with pulmonary bullae on chest imaging.
2. Severe heart disease (New York Heart Association [NYHA] functional class III or IV).
3. Comorbidities precluding the application of airway clearance techniques, such as rib fractures or recent thoracotomy.
4. Viral pneumonia.
5. Refusal to provide informed consent for study participation.
6. Requirement for mechanical ventilation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Aoki |
Organization
Nagasaki University Graduate School
Division name
Department of Physical Therapy Science, Biomedical Sciences
Zip code
8528034
Address
Sakamoto 1-7-1, Nagasaki, Japan
TEL
0958711515
bb55325801@ms.nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Aoki |
Organization
Nagasaki Memorial Hospital
Division name
Department of Rehabilitation
Zip code
8510301
Address
Fukahori 1-11-54, Nagasaki, Japan
TEL
0958711515
Homepage URL
bb55325801@ms.nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School of Biomedical Sciences Academic Cooperation Division
Address
1-12-4 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
0958197195
gakujutu_gakuji@ml.nagasaki-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 07 | Month | 31 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071272
