UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062554 |
|---|---|
| Receipt number | R000071605 |
| Scientific Title | Effects of Exercise and Training under Hypoxic Conditions on the Human Body |
| Date of disclosure of the study information | 2026/08/11 |
| Last modified on | 2026/08/11 17:41:06 |
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Basic information
Public title
Effects of repeated-sprint cycling training with breath holding on aerobic and anaerobic exercise capacity in young men
Acronym
VHL-RST Study
Scientific Title
Effects of Exercise and Training under Hypoxic Conditions on the Human Body
Scientific Title:Acronym
HET Study
Region
| Japan |
Condition
Condition
Exercise performance and training adaptations
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of four weeks of repeated-sprint cycling training with voluntary hypoventilation on aerobic capacity and anaerobic metabolic and exercise responses, compared with the same training performed with normal breathing, in healthy untrained young men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in body-mass-relative maximal oxygen uptake (VO2max) from pre-intervention to 3-7 days after the final training session.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom |
Interventions/Control_1
Repeated-sprint training with voluntary hypoventilation (RSH-VHL). Participants completed eight training sessions over 4 weeks, with two sessions per week, using a cycle ergometer. Each session comprised two sets of eight 6-s all-out cycling sprints against a resistance equivalent to 7.5% of body mass, with 30 s of passive recovery between sprints and 5 min of passive recovery between sets. Immediately before each sprint, participants exhaled as fully as possible and held their breath at low lung volume throughout the 6-s sprint. Breathing was resumed immediately after each sprint and was unrestricted during recovery. Before each session, participants completed a warm-up consisting of 3 min of cycling at 1.0 kp, one 6-s all-out sprint with normal breathing, and 5 min of passive rest.
Interventions/Control_2
Repeated-sprint training with normal breathing (RSN). Participants completed eight training sessions over 4 weeks, with two sessions per week, using a cycle ergometer. Each session comprised two sets of eight 6-s all-out cycling sprints against a resistance equivalent to 7.5% of body mass, with 30 s of passive recovery between sprints and 5 min of passive recovery between sets. Participants breathed normally during both the sprints and recovery periods. Before each session, participants completed a warm-up consisting of 3 min of cycling at 1.0 kp, one 6-s all-out sprint with normal breathing, and 5 min of passive rest.
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
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male university students aged 18-22 years who were not members of an athletic club or competitive sports team and were not engaged in regular structured exercise training. Participants were required to be able to safely perform high-intensity cycling exercise and to provide written informed consent after receiving an explanation of the study.
Key exclusion criteria
Individuals with cardiovascular disease or other health problems, those who could not safely perform high-intensity cycling exercise, and those judged by the investigators to be unable to complete the study procedures were excluded.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Yasuda |
Organization
Fukushima University
Division name
Faculty of Human Development and Culture
Zip code
9601296
Address
1 Kanayagawa, Fukushima, Japan
TEL
0245488209
yasuda@educ.fukushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Yasuda |
Organization
Fukushima University
Division name
Faculty of Human Development and Culture
Zip code
9601296
Address
1 Kanayagawa, Fukushima, Japan
TEL
0245488209
Homepage URL
yasuda@educ.fukushima-u.ac.jp
Sponsor or person
Institute
Fukushima University
Institute
Department
Personal name
Funding Source
Organization
Fukushima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Society for the Promotion of Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima University Research Ethics Committee
Address
1 Kanayagawa, Fukushima, Japan
Tel
0245488009
kyoudo@adb.fukushima-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
福島大学/Fukushima University
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
11
Results
Eleven participants started the intervention and 10 completed it. Relative VO2max increased from 38.8 +/- 6.8 to 46.5 +/- 5.7 mL/kg/min in RSH-VHL and from 40.7 +/- 3.1 to 43.2 +/- 4.7 in RSN, with a significant group-by-time interaction (p=0.024). Fatigue index also showed a significant interaction (p=0.028). Blood lactate increased over time without a group-by-time interaction (p=0.874).
Results date posted
| 2026 | Year | 08 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The 10 participants included in the complete-case analysis were healthy, untrained young men. Overall, age was 19.0 +/- 1.2 years, height 171.3 +/- 6.2 cm, and body mass 58.4 +/- 5.5 kg. In RSH-VHL (n=5), age was 18.6 +/- 0.9 years, height 172.0 +/- 7.2 cm, and body mass 58.9 +/- 6.0 kg. In RSN (n=5), age was 19.4 +/- 1.5 years, height 170.6 +/- 5.7 cm, and body mass 57.8 +/- 5.6 kg. Values are mean +/- SD.
Participant flow
Eleven participants were enrolled and initiated the intervention. Five were allocated to RSN and all completed the eight training sessions and post-intervention assessments. Six were allocated to RSH-VHL; one withdrew after two training sessions because of intolerance to the combination of the breath-holding technique and repeated maximal sprint exercise and did not undergo post-intervention assessments. The final complete-case analysis included five participants in each group (n=10).
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 11 | Day |
Last modified on
| 2026 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071605
