UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060290 |
|---|---|
| Receipt number | R000068949 |
| Scientific Title | Hyperventilation and Perceived Exertion in Sustained Cycling at Anaerobic Threshold: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2026/01/07 19:49:08 |
* 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 Breathing Techniques on Fatigue During Cycling Exercise
Acronym
Breathing and Cycling Fatigue Study
Scientific Title
Hyperventilation and Perceived Exertion in Sustained Cycling at Anaerobic Threshold: A Randomized Crossover Trial
Scientific Title:Acronym
Hyperventilation Cycling Fatigue Trial
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether intentional hyperventilation during sustained cycling at anaerobic threshold intensity affects perceived exertion (dyspnea and leg fatigue)
Basic objectives2
Others
Basic objectives -Others
To evaluate the impact of hyperventilation on ventilatory efficiency and respiratory muscle workload, providing fundamental insights for optimizing breathing strategies during endurance exercise.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Borg rating of perceived exertion for dyspnea, Borg rating of perceived exertion for leg fatigue
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intentional hyperventilation synchronized to each pedal stroke (approximately 50 breaths/min) during 20 minutes of cycling at anaerobic threshold intensity.
Interventions/Control_2
Slower breathing synchronized to every two pedal strokes (approximately 25 breaths/min) during 20 minutes of cycling at anaerobic threshold intensity.
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
| 21 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy young adults (approximately 18-30 years old)
Able to synchronize breathing with pedaling during the practice session
Provided written and verbal informed consent after receiving details of the study purpose, procedures, and potential risks
Key exclusion criteria
History of respiratory or cardiovascular disease
Musculoskeletal disorders affecting pedaling
Current or former smoking history
Recent upper respiratory tract infection (within one week)
Unable to synchronize breathing during the practice session
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Aoki |
Organization
Shijonawate Gakuen University
Division name
Faculty of rehabilitation
Zip code
574-0011
Address
5-11-10, Hojo, Daito, Osaka
TEL
+81-72-863-5043
o-aoki@reha.shijonawate-gakuen.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Aoki |
Organization
Shijonawate Gakuen University
Division name
Faculty of rehabilitation
Zip code
574-0011
Address
5-11-10, Hojo, Daito, Osaka
TEL
+81-72-863-5043
Homepage URL
o-aoki@reha.shijonawate-gakuen.ac.jp
Sponsor or person
Institute
Shijonawate Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Shijonawate Gakuen University
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
Shijonawate Gakuen University
Address
5-11-10, Hojo, Daito, Osaka
Tel
+81-72-863-5043
o-aoki@reha.shijonawate-gakuen.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 | 01 | 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
21
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The study has been completed; however, result disclosure has been delayed due to the time required for manuscript preparation. The results will be made public after the manuscript is submitted and accepted.
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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068949
