UMIN-CTR Clinical Trial

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 Dalila Middle name Last name Burin
Organization	Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name	Smart-Aging International Research Center (SAIRC)
Zip code	980-8575
Address	4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
TEL	022-717-7988
Homepage URL
Email	burin.dalila.c3@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	2021 Year 01 Month 17 Day

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