UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061767 |
|---|---|
| Receipt number | R000070460 |
| Scientific Title | Effects of Balloon-Blowing Training on Respiratory Function |
| Date of disclosure of the study information | 2026/06/02 |
| Last modified on | 2026/06/02 15:11:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Balloon-Blowing Training on Respiratory Function
Acronym
Effects of Balloon-Blowing Training on Respiratory Function
Scientific Title
Effects of Balloon-Blowing Training on Respiratory Function
Scientific Title:Acronym
Effects of Balloon-Blowing Training on Respiratory Function
Region
| Japan |
Condition
Condition
Healthy university students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focuses on balloon-inflating training and aims to examine its effects on respiratory function by implementing an intervention over a specified period. Specifically, as a preliminary intervention study, this research aims to clarify the safety, feasibility, and preliminary trends regarding the effectiveness of the intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory function and respiratory muscle strength as measured by spirometry
Key secondary outcomes
Physical fitness tests (sit-ups)
Maximum phonation time
Quality of life (QOL): Short Form 8 Health Survey (SF-8)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Performed balloon-blowing training
Interventions/Control_2
Diaphragmatic breathing
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy university students
Key exclusion criteria
If you have orthopedic conditions or respiratory diseases such as asthma, and it is difficult for you to participate in the measurement
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Sawaya |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
324-8501
Address
2600-1 Kitakanemaru, Otawara, Tochigi
TEL
0287-24-3018
sawaya@ihwg.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sawaya |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
324-8501
Address
2600-1 Kitakanemaru, Otawara, Tochigi
TEL
0287-24-3018
Homepage URL
sawaya@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
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
International University of Health and Welfare
Address
2600-1 Kitakanemaru, Otawara, Tochigi
Tel
0287-24-3018
sawaya@ihwg.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 | 06 | Month | 02 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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 | 06 | Month | 02 | Day |
Last modified on
| 2026 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070460
