UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039843 |
|---|---|
| Receipt number | R000045441 |
| Scientific Title | The effect of virtual reality exercise training on cognitive function for the elderly |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2020/03/17 10:36:33 |
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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
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
burin.dalila.c3@tohoku.ac.jp
Sponsor or person
Institute
Institue of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045441
