UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062421 |
|---|---|
| Receipt number | R000071389 |
| Scientific Title | Effects of lung volume recruitment training using a lung insufflation capacity trainer and maximum insufflation capacity training on respiratory function in healthy male adults: a randomized crossover pilot trial |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/07/31 13:30:22 |
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Basic information
Public title
Effects of maximum insufflation training on respiratory function
Acronym
Maximum insufflation training and respiratory function
Scientific Title
Effects of lung volume recruitment training using a lung insufflation capacity trainer and maximum insufflation capacity training on respiratory function in healthy male adults: a randomized crossover pilot trial
Scientific Title:Acronym
LIC-MIC Trial
Region
| Japan |
Condition
Condition
Neuromuscular diseases (including amyotrophic lateral sclerosis [ALS])
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of lung insufflation capacity (LIC) training and maximum insufflation capacity (MIC) training as lung volume recruitment (LVR) techniques on respiratory function and perceived difficulty in healthy male adults, and to obtain preliminary evidence for future studies in patients with neuromuscular diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in vital capacity (VC) from baseline to the end of the 4-week intervention.
Key secondary outcomes
Change in forced vital capacity from baseline to the end of the 4-week intervention.
Change in forced expiratory volume in one second from baseline to the end of the 4-week intervention.
Change in forced expiratory volume in one second as a percentage of forced vital capacity from baseline to the end of the 4-week intervention.
Perceived difficulty of the intervention assessed using a visual analogue scale immediately after each intervention session.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Lung insufflation capacity (LIC) training was performed as a lung volume recruitment (LVR) technique using the LIC TRAINER equipped with a one-way valve. The intervention was performed in the supine position with a pillow and the lower limbs extended, once weekly for 4 weeks. Each session consisted of three maximal insufflations with a 5-second breath hold, with adequate rest between repetitions. All interventions were administered by the principal investigator.
Interventions/Control_2
Maximum insufflation capacity (MIC) training was performed using a bag-valve mask. The intervention was performed in the supine position with a pillow and the lower limbs extended, once weekly for 4 weeks. Each session consisted of three maximal insufflations with a 5-second breath hold, with adequate rest between repetitions. All interventions were administered by the principal investigator.
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
| 19 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male students enrolled in the Department of Physical Therapy, Osaka University of Human Sciences, who provided written informed consent to participate in the study.
Key exclusion criteria
Individuals with a history of respiratory diseases, including spontaneous pneumothorax or asthma, and students enrolled in the seminar supervised by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Tamada |
Organization
Japan University of Health Sciences
Division name
Department of Physical Therapy School of Health Sciences
Zip code
340-0145
Address
2-555 Hirasuka, Satte-City, Saitama
TEL
0480-48-5806
y-tamada@jhsu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Tamada |
Organization
Japan University of Health Sciences
Division name
Department of Physical Therapy School of Health Sciences
Zip code
340-0145
Address
2-555 Hirasuka, Satte-City, Saitama
TEL
0480-48-5806
Homepage URL
y-tamada@jhsu.ac.jp
Sponsor or person
Institute
Japan University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Osaka University of Human Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University of Human Sciences
Address
1-4-1 Shojaku, Settsu-City, Osaka
Tel
06-6381-3000
y-tamada@ohs.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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
8
Results
Eight participants were enrolled and seven completed the study and were included in the analysis. Vital capacity (VC) showed a significant effect of time, whereas no significant treatment effect or treatment-by-time interaction was observed. No significant intervention effects were found for forced vital capacity (FVC), forced expiratory volume in one second (FEV1), or FEV1/FVC. Visual analogue scale (VAS) scores did not differ between interventions, and no adverse events occurred.
Results date posted
| 2026 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eight healthy male students enrolled in the Department of Physical Therapy at Osaka University of Human Sciences participated in this study. The mean age was approximately 19 years. Participants with a history of respiratory disease were excluded. All participants underwent both LIC and MIC training in a randomized crossover design.
Participant flow
Eight participants were enrolled and randomized to the intervention sequence. One participant was excluded from the analysis because he was unable to complete the study protocol due to absence from two consecutive intervention sessions. Consequently, seven participants completed the study and were included in the final analysis.
Adverse events
No adverse events related to either LIC or MIC training were observed during the study.
Outcome measures
The primary outcome, vital capacity (VC), showed a significant effect of time, whereas no significant treatment effect or treatment-by-time interaction was observed. No significant differences between interventions were found for the secondary outcomes, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, and visual analogue scale (VAS) scores.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 28 | 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=R000071389
