UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061187 |
|---|---|
| Receipt number | R000070021 |
| Scientific Title | Effects of Balloon Blowing Exercise on Diaphragm Function and Spinal and Thoracic Mobility in Healthy Adults |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/07 18:28:51 |
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Basic information
Public title
Effects of Respiratory Exercise (Balloon Blowing Exercise) on Diaphragm Function and Spinal and Thoracic Mobility
Acronym
BBE-DSTM Study
Scientific Title
Effects of Balloon Blowing Exercise on Diaphragm Function and Spinal and Thoracic Mobility in Healthy Adults
Scientific Title:Acronym
BBE-DSTM
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the immediate effects of Balloon Blowing Exercise (BBE) on diaphragm function and spinal and thoracic mobility in healthy adults. Additionally, this study aims to examine the relationship between changes in diaphragm function and changes in spinal and thoracic mobility following the intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diaphragm thickness
Diaphragm excursion measured
Key secondary outcomes
Chest expansion
Spinal mobility
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In the intervention condition, participants will perform Balloon Blowing Exercise (BBE). One breathing cycle consists of a 4-second inhalation, an 8-second exhalation into a balloon, followed by a 3-second breath hold. Participants will perform 3 breaths per set for a total of 3 sets.
Interventions/Control_2
In the control condition, participants will perform quiet breathing under the same posture and timing conditions.
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy male adults aged 18-30 years
Individuals who have received a full explanation of the study and provided written informed consent
Key exclusion criteria
Individuals with a history of or current low back pain
Individuals with a history of respiratory, musculoskeletal, or neurological disorders
Individuals with smoking habits
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kai |
| Middle name | |
| Last name | Higashikubo |
Organization
Niigata University of Health and Welfare, Graduate School
Division name
Division of Physical Therapy, Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata 950-3198, Japan
TEL
025-257-4455
hpm25018@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kai |
| Middle name | |
| Last name | Higashikubo |
Organization
Niigata University of Health and Welfare, Graduate School
Division name
Division of Physical Therapy, Health Sciesnce
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata 950-3198, Japan
TEL
025-257-4455
Homepage URL
hpm25018@nuhw.ac.jp
Sponsor or person
Institute
Niigata 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
Institutional Review Board of Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata 950-3198, Japan
Tel
025-257-4455
hpm25018@nuhw.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 | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 01 | 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 | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070021
