UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054986 |
|---|---|
| Receipt number | R000062825 |
| Scientific Title | Investigation on quantifying objective indicators in hypoxic training for competitive cyclists. |
| Date of disclosure of the study information | 2024/07/17 |
| Last modified on | 2024/07/17 03:04:36 |
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Basic information
Public title
Investigation on quantifying objective indicators in hypoxic training for competitive cyclists.
Acronym
Investigation on quantifying objective indicators in hypoxic training for competitive cyclists.
Scientific Title
Investigation on quantifying objective indicators in hypoxic training for competitive cyclists.
Scientific Title:Acronym
Investigation on quantifying objective indicators in hypoxic training for competitive cyclists.
Region
| Japan |
Condition
Condition
healthy adults(cyclists)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the differences in TSS (Training quantification index calculated from pedaling power) during training in a normal and hypoxic environment for cyclists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
TSS(Training Stress Score), Heart rate(eTRIMP), Blood lactate concentration, Borg scale(RPE)
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
Active
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
Training in a normal or hypoxic environment is carried out for 3 days each. Hypoxic training is preceded by three days of acclimatization to altitudes.
Interventions/Control_2
Perform 3 sets of 8-minute pedaling exercise with a pedaling power equivalent to 70% VO2max (2 minute breaks in between).
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
A male cyclist who has finished in the top three in the middle and long distance events at national championships within the past three years and has no experience in hypoxic training
Key exclusion criteria
Participants are excluded if they were unable to complete the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | ERIKO |
| Middle name | |
| Last name | MATSUO |
Organization
Nihon University
Division name
College of Sports Sciences
Zip code
154-0002
Address
3-34-1, Shimouma, Setagaya-ku, Tokyo
TEL
03-6453-1767
matsuo.eriko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | ERIKO |
| Middle name | |
| Last name | MATSUO |
Organization
Nihon University
Division name
College of Sports Sciences
Zip code
154-0002
Address
3-34-1, Shimouma, Setagaya-ku, Tokyo
TEL
03-6453-1767
Homepage URL
matsuo.eriko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon 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
Nihon University College of Sports Sciences
Address
3-34-1, Shimouma, Setagaya-ku, Tokyo
Tel
03-6453-1600
rmss.kenkyu@nihon-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
日本大学スポーツ科学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062825
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
