UMIN-CTR Clinical Trial

Basic information
Public title	An intervention study to investigate the validity of a new evaluation method for cardiorespiratory fitness
Acronym	Validation study for a new fitness test
Scientific Title	An intervention study to investigate the validity of a new CRF evaluation method developed by the J-NIOSH
Scientific Title:Acronym	Validation study for a new CRF evaluation method
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate through an exercise intervention experiment whether the predicted value changes along with change in the criterion value (measured VO2max)
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Measured VO2max (pre-intervention, middle-intervention, post-intervention)
Key secondary outcomes	Predicted VO2max (pre-intervention, middle-intervention, post-intervention)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	4-week high-intensity interval exercise training (3 times/week) followed by 4-week non-exercise period
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	29 years-old >=
Gender	Male
Key inclusion criteria	Without exercise habit / Without high fitness level (roughly 45 ml/kg/min or less of VO2max)
Key exclusion criteria	With history of heart or brain disease / With medical conditions that could affect high-intensity exercises / Observed high-risk arrhythmia during exercise test
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Tomoaki Middle name Last name Matsuo
Organization	National Institute of Occupational Safety and Health, Japan
Division name	Ergonomics Research Group
Zip code	214-8585
Address	Nagao 6-21-1, Tama-Ku, Kawasaki
TEL	044-865-6111
Email	matsuo@h.jniosh.johas.go.jp

Public contact
Name of contact person	1st name Tomoaki Middle name Last name Matsuo
Organization	National Institute of Occupational Safety and Health, Japan
Division name	Ergonomics Research Group
Zip code	214-8585
Address	Nagao 6-21-1, Tama-Ku, Kawasaki
TEL	044-865-6111
Homepage URL
Email	matsuo@h.jniosh.johas.go.jp

Sponsor
Institute	National Institute of Occupational Safety and Health, Japan Ergonomics Research Group
Institute
Department

Funding Source
Organization	National Institute of Occupational Safety and Health, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	THF Co.,Ltd
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethical Committee of the National Institute of Occupational Safety and Health, Japan
Address	Nagao 6-21-1, Tama-Ku, Kawasaki
Tel	044-865-6111
Email	sasakit@h.jniosh.johas.go.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	株式会社THF（茨城県）

Other administrative information
Date of disclosure of the study information	2020 Year 07 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	Completed
Date of protocol fixation	2020 Year 04 Month 30 Day
Date of IRB	2020 Year 05 Month 08 Day
Anticipated trial start date	2020 Year 07 Month 10 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 08 Day
Last modified on	2022 Year 02 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046855