UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039639 |
|---|---|
| Receipt number | R000044786 |
| Scientific Title | Development of novel exercise prescription system using heart rate variability |
| Date of disclosure of the study information | 2020/03/20 |
| Last modified on | 2021/03/16 09:00:50 |
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Basic information
Public title
Development of novel exercise prescription system
Acronym
NESH-V study
Scientific Title
Development of novel exercise prescription system using heart rate variability
Scientific Title:Acronym
NESH-V study
Region
| Japan |
Condition
Condition
Healthy subjects, cardiovascular disease, Metabolic disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the non-invasive and accurately prescription systems for exercise by using heart rate variability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of exercise intensity during incremental exercise using frequency components in real-time heart rate variability analysis.
Key secondary outcomes
Evaluation of autonomic nervous activities during incremental exercise using frequency components in real-time heart rate variability analysis.
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Single arm: Incremental exercise test
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects 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
Who have severe or progressive disorder.
Who are restricted exercise.
Who are taking alpha-blockers or beta-blockers.
Target sample size
60
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, 814-0180, Japan
TEL
092-871-6631
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, 814-0180, Japan
TEL
092-871-6631
Homepage URL
http://www.fuipa.spo.fukuoka-u.ac.jp/
shihoko@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
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
Fukuoka University Institutional Review Board
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
Tel
092-871-6631
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 20 | 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
15
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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044786
