UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057334 |
|---|---|
| Receipt number | R000065534 |
| Scientific Title | Investigation of a method for evaluating the psychological condition of athletes using non-invasive vital data. |
| Date of disclosure of the study information | 2025/03/19 |
| Last modified on | 2026/03/04 09:31:38 |
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Basic information
Public title
Investigation of a method for evaluating the psychological condition of athletes using non-invasive vital data.
Acronym
Investigation of methods for evaluating the psychological condition of athletes
Scientific Title
Investigation of a method for evaluating the psychological condition of athletes using non-invasive vital data.
Scientific Title:Acronym
Investigation of methods for evaluating the psychological condition of athletes
Region
| Japan |
Condition
Condition
Healthy athlete
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to verify a method for evaluating objective psychological condition by analysing daily heart rate variability using wearable devices in athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate, Heart rate variability
Key secondary outcomes
Characteristics, Daily subjective evaluation, Japanese version Perceived Stress Scale, Japanese version Profile of Mood States Second Edition, Sports performance in match
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)regular exercise at least three times a week
2)university student affiliated with a university sports association
3)Fully understand the purpose of this test and agree to participate in it
4)Be able to prepare a smartphone and email address
Key exclusion criteria
1)Not participating in training due to injury or mental illness at the time of participation
2)Planning to retire from club activities within 6 months of participating in the study
3)Those deemed unsuitable for the study by the principal investigator or sub-investigators
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Katsumata |
Organization
Keio University School of Medicine
Division name
Institute for Integrated Sports Medicine,
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3812
keio.orthopedics.sawada.okawara@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Okawara |
Organization
Keio University School of Medicine
Division name
Department of Orithopaedic surgery
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3812
Homepage URL
keio.orthopedics.sawada.okawara@gmail.com
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
Yoshinori Katsumata
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
UNINVAS
IRB Contact (For public release)
Organization
Department of Orthopaedics, Keio University, School of Medicine
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japannom
Tel
03-5363-3879
med-rinri-jimu@adst.keio.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
| 2025 | Year | 03 | Month | 19 | 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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Measures daily heart rate and heart rate variability using wearable device
Management information
Registered date
| 2025 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065534
