UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041031 |
|---|---|
| Receipt number | R000046855 |
| Scientific Title | An intervention study to investigate the validity of a new CRF evaluation method developed by the J-NIOSH |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2022/02/02 15:04:16 |
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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
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
matsuo@h.jniosh.johas.go.jp
Sponsor or person
Institute
National Institute of Occupational Safety and Health, Japan
Ergonomics Research Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046855
