UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055461 |
|---|---|
| Receipt number | R000062335 |
| Scientific Title | Examination of factors determining heart rate variability resilience |
| Date of disclosure of the study information | 2024/09/10 |
| Last modified on | 2025/03/28 16:57:04 |
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Basic information
Public title
Examination of factors determining heart rate variability resilience
Acronym
Study of heart rate variability resilience
Scientific Title
Examination of factors determining heart rate variability resilience
Scientific Title:Acronym
Study of heart rate variability resilience
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the relationship between endurance fitness or physical activity and heart rate variability response or recovery by physical load
Basic objectives2
Others
Basic objectives -Others
To reveal the relationship between catecholamines or oxytocin and heart rate variability response or recovery by physical load.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability during and after exercise.
Key secondary outcomes
Catecholamines and oxytocin during and after exercise.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females from 18 to 59 year
Key exclusion criteria
1) Who have been prohibited from exercising by a doctor
2) Who with or a history of cardiovascular disease (heart disease, high blood pressure), metabolic disease (diabetes, dyslipidemia), or other serious diseases (renal failure, severe obesity, orthopedic disorders, etc.)
3) Who are visiting a hospital or taking medication for arrhythmia
4) Who are visiting a hospital or taking medication for depression or other mental disorders
5) Who are taking medication for diabetes, dyslipidemia, alpha blockers, or beta blockers
6) Smokers
7) Who regularly consume large amounts of alcohol (average alcohol intake of 60g or more per day)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Murakami |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
TEL
077-561-2890
haruka-m@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Murakami |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
TEL
077-561-2890
Homepage URL
haruka-m@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board for Medical and Health Research Involving Human Subjects
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
Tel
077-599-4175
b-rinri@st.ritsumei.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
| 2024 | Year | 09 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exposures: exercise
Outcome: Heart rate variability response during and after exercise
Management information
Registered date
| 2024 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062335
