UMIN-CTR Clinical Trial

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
Email	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/
Email	shihoko@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044786