UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049109 |
|---|---|
| Receipt number | R000055387 |
| Scientific Title | Effects of active video games (Nintendo Ring Fit Adventure) on physical and cognitive functions among community-dwelling older people |
| Date of disclosure of the study information | 2022/10/06 |
| Last modified on | 2024/03/25 09:46:21 |
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Basic information
Public title
Effects of active video games on health parameters among community-dwelling older people
Acronym
Effects of active video games on health parameters among community-dwelling older people
Scientific Title
Effects of active video games (Nintendo Ring Fit Adventure) on physical and cognitive functions among community-dwelling older people
Scientific Title:Acronym
Effects of active video games (Nintendo Ring Fit Adventure) on physical and cognitive functions among community-dwelling older people
Region
| Japan |
Condition
Condition
Long-term care
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effect of active video games (Nintendo Ring Fit Adventure) on physical fitness and cognitive functions among community-dwelling older people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
fitness
Key secondary outcomes
fitness (aerobic capacity, muscle strength, balance, and walking ability), anthropometrics (height and weight), resting blood pressure, cognitive functions (Trail Making Test), objective measured sleep parameters, physical activity levels, subjectively measured sleep, loneliness, exercise enjoyment, positive & negative affect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participating in exercise classes using video games (2 times/week, for 6 weeks)
Interventions/Control_2
The control group are asked to maintain their normal lifestyle.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged 60 or older
(2) Those who can participate in exercise classes twice a week.
Key exclusion criteria
(1) Those who have difficulty in knee extension and flexion during standing exercise.
(2) Those whose resting systolic blood pressure is 180 mmHg or higher
(3) Those who are prohibited from exercising by their family physician.
(4) Those who have participated in other programs (exercise programs, weight loss and other dietary guidance) in the last 6 months.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Miyazaki |
Organization
Shimane University
Division name
Faculty of Human Sciences
Zip code
690-8504
Address
1060 Nishikawatsu, Matsue City, Shimane
TEL
0852-32-9059
miyazaki@hmn.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Miyazaki |
Organization
Shimane University
Division name
Faculty of Human Sciences
Zip code
690-8504
Address
1060 Nishikawatsu, Matsue City, Shimane
TEL
0852-32-9059
Homepage URL
miyazaki@hmn.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of Faculty of Human Sciences of Shimane University
Address
gak-somubun@office.shimane-u.ac.jp
Tel
0852-32-6251
gak-somubun@office.shimane-u.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
| 2022 | Year | 10 | Month | 06 | 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
32
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
| 2022 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055387
