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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041124
Receipt No. R000046963
Scientific Title Effects of Physical Training in Virtual Reality on Stress Response
Date of disclosure of the study information 2020/07/16
Last modified on 2020/07/16

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Basic information
Public title Effects of Physical Training in Virtual Reality on Stress Response
Acronym Virtual Training Reduces Stress Response
Scientific Title Effects of Physical Training in Virtual Reality on Stress Response
Scientific Title:Acronym Virtual Training Reduces Stress Response
Region
Japan

Condition
Condition Stress response.
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to investigate the benefits induced by virtual training on stress response.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Salivary enzyme alpha-amylase concentration.
Key secondary outcomes Heart rate.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 intervention: virtual training in first-person perspective
Interventions/Control_2 control: virtual training in third-person perspective
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
35 years-old >=
Gender Male and Female
Key inclusion criteria 20-35 years old healthy Japanese adults
Key exclusion criteria People who have or had any neurological or psychological disorders (especially related to anxiety), females who are taking oral contraceptive drugs, and heavy drinking, any motor or neurological disorders, strong motion sickness are ineligible for the present study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Ryuta
Middle name
Last name Kawashima
Organization Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name Department of Functional Brain Imaging
Zip code 980-8575
Address 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
TEL 022-717-7988
Email ryuta@tohoku.ac.jp

Public contact
Name of contact person
1st name Yingxu
Middle name
Last name Liu
Organization Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name Department of Functional Brain Imaging
Zip code 980-8575
Address 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
TEL 022-717-7988
Homepage URL
Email liu.yingxu.p8@dc.tohoku.ac.jp

Sponsor
Institute Institute of Development, Aging and Cancer (IDAC), Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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 07 Month 16 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 Month 01 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 16 Day
Last modified on
2020 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046963

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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