UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048962 |
|---|---|
| Receipt number | R000053373 |
| Scientific Title | Study on novel aerobic fitness assessment using wearable devise |
| Date of disclosure of the study information | 2022/09/21 |
| Last modified on | 2022/09/19 21:17:25 |
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Basic information
Public title
Development of novel endurance assessment using wearable devise
Acronym
Development of novel endurance assessment
Scientific Title
Study on novel aerobic fitness assessment using wearable devise
Scientific Title:Acronym
Study on novel aerobic fitness assessment
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the novel assessment of aerobic fitness from heart rate variability using wearable device
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lactate and ventilatory threshold estimation using heart rate variability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Incremental exercise test (Cycling, Running)
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy men whose age is above 20 years old and weight is above 50 kg
2) Individuals who understand the purpose and contents of the study, have ability to provide written consent, and give the written informed consent form
Key exclusion criteria
1) Who have severe or progressive disorder
2) Who have been banned exercise
3) Who have arrhythmia
4) Constant use of medicine
5) Who drink a lot of alcohol
6) Who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Uehara |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka
TEL
092-871-6631(6732)
ueharay@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shihoko |
| Middle name | |
| Last name | Nakashima |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka
TEL
092-871-6631
Homepage URL
shihoko@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Institutional Review Board
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka
Tel
092-871-6631 (2813)
suisin@adm.fukuoka-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
福岡大学スポーツ科学部（福岡）
基盤研究機関身体活動研究所（福岡）
Fukuoka University in Faculty of Sports and Health Science
Central Research Institute for Physical Activity
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 21 | 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
14
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 19 | Day |
Last modified on
| 2022 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053373
| 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 |
