UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063076 |
|---|---|
| Receipt number | R000072207 |
| Scientific Title | Study on the Effects of Heart Rate Variability on Physical Performance |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 14:58:26 |
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Basic information
Public title
Effects of Heart Rate Variability-Guided and Predetermined Training on Aerobic Performance
Acronym
Effects of Heart Rate Variability-Guided and Predetermined Training on Aerobic Performance
Scientific Title
Study on the Effects of Heart Rate Variability on Physical Performance
Scientific Title:Acronym
Study on the Effects of Heart Rate Variability on Physical Performance
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether heart rate variability-guided training, in which daily training is prescribed based on heart rate variability, affects aerobic adaptations compared with predetermined training when training monotony is matched between the groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changing in maximal aerobic power assessed by an incremental load test from pre- and post- training intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
HRV-guided training (HRV-G): During the 4-week training period, daily training is prescribed based on morning heart rate variability (LnRMSSD). Low-intensity continuous cycling is performed for 40 min at the lactate threshold intensity. High-intensity interval cycling consists of 4 sets of 4 min at 90% of heart rate reserve followed by 3 min at 50% of heart rate reserve. High-intensity interval cycling, low-intensity continuous cycling, or rest is prescribed according to morning LnRMSSD.
Interventions/Control_2
Predetermined training (PD): During the 4-week training period, participants perform a predetermined training program. Low-intensity continuous cycling is performed for 40 min at the lactate threshold intensity. High-intensity interval cycling consists of 4 sets of 4 min at 90% of heart rate reserve followed by 3 min at 50% of heart rate reserve. The PD group performs two low-intensity continuous cycling and one High-intensity interval cycling per week.
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
Adult males aged 18-25 years.
Physically and mentally healthy individuals without known disease.
Individuals who exercise regularly.
Individuals without physical abnormalities based on their regular health examination and health status at the start of the study.
Key exclusion criteria
Individuals with an implanted pacemaker.
Individuals taking medication regularly.
Individuals with abnormal cardiovascular responses.
Individuals with physical abnormalities identified by their regular health examination or health assessment at the start of the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Takai |
Organization
National Institute of Fitness and Sports in Kanoya
Division name
Sports adn Life Science Division
Zip code
893.-2393
Address
Shiromizucho 1, Kanoya, Kagoshima
TEL
0994-46-4992
y-takai@nifs-k.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Takai |
Organization
National Institute of Fitness and Sports in Kanoya
Division name
Sports and Life Science Division
Zip code
893.-2393
Address
Shiromizucho 1, Kanoya, Kagoshima
TEL
0994-46-4992
Homepage URL
y-takai@nifs-k.ac.jp
Sponsor or person
Institute
National Institute of Fitness and Sports in Kanoya
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Fitness and Sports in Kanoya Natural Sciences Ethcs Subcommittee
Address
Shiromizucho 1, Kanoya, Kagoshima
Tel
0994-46-4871
kokusai@nifs-k.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
鹿屋体育大学（鹿児島）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Not publicly available
Publication of results
Unpublished
Result
URL related to results and publications
Not publicly available
Number of participants that the trial has enrolled
20
Results
PPO, P2mmol, and P4mmol significantly increased after training in both groups, with no significant group-by-time interactions. No significant between-group differences were observed in TRIMP, training monotony, or training strain. Aerobic power adaptations were comparable between HRV-guided and predetermined training when training monotony was matched.
Results date posted
| 2026 | Year | 09 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty physically active men participated in the study. The predetermined training group consisted of 10 participants (age, 20.9 +/- 1.4 years; height, 175.7 +/- 5.9 cm; body mass, 71.1 +/- 6.8 kg), and the HRV-guided training group consisted of 10 participants (age, 20.2 +/- 0.9 years; height, 173.8 +/- 5.0 cm; body mass, 70.0 +/- 5.7 kg). No significant between-group differences were observed in physical characteristics or physiological variables at baseline.
Participant flow
Twenty participants were assigned to either the predetermined training group (n=10) or the HRV-guided training group (n=10). All 20 participants completed the 5-week training intervention and were included in the analysis.
Adverse events
No adverse events related to the study were reported.
Outcome measures
The primary outcome, maximal aerobic power (PPO), increased from 4.4 +/- 0.3 W/kg to 4.9 +/- 0.5 W/kg in the predetermined training group and from 4.5 +/- 0.5 W/kg to 5.0 +/- 0.4 W/kg in the HRV-guided training group. A significant main effect of time was observed, whereas the group-by-time interaction was not significant.
Plan to share IPD
De-identified study data will be available from the corresponding author upon reasonable request.
IPD sharing Plan description
Study data will be available from the corresponding author upon reasonable request after consideration of the purpose and appropriateness of the proposed data use.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 20 | Day |
Other
Other related information
This trial was registered retrospectively. The trial was not prospectively registered at the time of study initiation. During the editorial assessment of the manuscript, trial registration was requested by the journal; therefore, the trial was retrospectively registered to ensure transparency. The registration record reflects the original study plan and the study protocol actually implemented.
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072207
