UMIN-CTR Clinical Trial

Basic information
Public title	The effect of exercise intervention in virtual reality on cognitive function using immersive virtual reality technology
Acronym	The effect of exercise intervention in virtual reality on cognitive function
Scientific Title	The effect of exercise intervention in virtual reality on cognitive function using immersive virtual reality technology
Scientific Title:Acronym	The effect of exercise intervention in virtual reality on cognitive function
Region	Japan

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

Objectives
Narrative objectives1	To examine the influence of exercise training using immersive virtual reality on cognitive function and mood.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	functional Near-Infrared Spectroscopy
Key secondary outcomes	the color-word matching Stroop test the Two Dimension Mood Scale Heart rate the questionnaire on ownership and agency

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Condition of virtual whole-body illusion in first person's viewpoint. : A subject sitting in a chair sees the avatar's body and legs displayed in conformity with his / her body.
Interventions/Control_2	Condition for displaying avatar from third person viewpoint. Subjects sitting in a chair can see the avatar's body and legs next to themselves as if they were watching another person.
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	31 years-old >
Gender	Male and Female
Key inclusion criteria	Right handed 20 to 30 year old healthy men and women with Japanese as their mother tongue
Key exclusion criteria	Exclusion criteria will be with history of motor or somatosensory problems, history of motor disorders, history of gate or posture disorders, history of mental illness, people taking drugs that affect cognitive or motor function (e.g. benzodiazepines, antidepressants, central nervous system drugs),people with colorblindness.
Target sample size	52

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ryuta Kawashima
Organization	Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name	Department of Functional Brain Imaging
Zip code
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 Middle name Last name Burin Dalila
Organization	Tohoku University
Division name	Smart-Aging Research Organization
Zip code
Address	4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan
TEL	022-717-7988
Homepage URL
Email	burin.dalila.c3@tohoku.ac.jp

Sponsor
Institute	Institue of Development, Aging and Cancer, Tohoku University
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 10 Month 01 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	2018 Year 06 Month 04 Day
Date of IRB	2018 Year 07 Month 23 Day
Anticipated trial start date	2018 Year 10 Month 04 Day
Last follow-up date	2019 Year 03 Month 15 Day
Date of closure to data entry	2019 Year 03 Month 15 Day
Date trial data considered complete	2019 Year 04 Month 01 Day
Date analysis concluded	2019 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 25 Day
Last modified on	2021 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039052