UMIN-CTR Clinical Trial

Basic information
Public title	Lon-term effects on cognitive functions of exercise intervention using immersive virtual reality technology for elderly.
Acronym	The effect of exercise intervention in virtual reality on cognitive function for elderly.
Scientific Title	The effect of virtual reality exercise training on cognitive function for the elderly
Scientific Title:Acronym	The effect of virtual reality exercise training on cognitive function for the elderly
Region	Japan

Condition
Condition	healthy elderly
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	functional Near-Infrared Spectroscopy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	60 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects are 60 right-handed males and females, 60 and older, who are native speakers of Japanese.
Key exclusion criteria	Those with a history of motor and sensory organs. A history of motor organ disease. Those who have a history of disability in walking or posture. Those with a history of mental illness. Taking drugs that may affect cognitive or motor function (eg, benzodiazepines, antidepressants, central nervous drugs). Those with color blindness. Those that are easy to get motion sick. Elderly people treated for geriatric diseases such as hypertension and diabetes are not included in the exclusion criteria. However, people are checked on a case-by-case basis.
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	Tohoku University
Division name	Smart-Aging Research Organization
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	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	Tohoku University
Address	Institute of Development, Aging and cancer
Tel	022-717-7988
Email	burin.dalila.c3@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 03 Month 18 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 02 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2020 Year 08 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 03 Month 17 Day
Last modified on	2020 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045441