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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027740
Receipt No. R000031784
Scientific Title Effects of cognitive and physical training in older adults: A randomized control trial
Date of disclosure of the study information 2017/06/13
Last modified on 2018/12/14

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Basic information
Public title Effects of cognitive and physical training in older adults: A randomized control trial
Acronym Cognitive and physical training in older adults
Scientific Title Effects of cognitive and physical training in older adults: A randomized control trial
Scientific Title:Acronym Cognitive and physical training in older adults
Region
Japan

Condition
Condition Older adults
Classification by specialty
Neurology Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effect of cognitive and physical training in older adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Timed Up and Go test
Trail Making Test
Key secondary outcomes Physical function: Grip strength, Short Physical Performance Battery, Muscle mass
Cognitive function: Mini Mental State Examination, Rivermead Behavioral Memory Test story (immediate recall, delayed recall), Wechsler Memory Scale logical memory, Montreal Cognitive Assessment, Stroop test, Cognitive Assessment & Training Tool, Digit Symbol Substitution Test
QOL: Sort Form-36

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
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 physical and cognitive intervention
Interventions/Control_2 No treatment control
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) 70 years or older
2) Participants being able to come to Kobe university
Key exclusion criteria 1) Impairment in Basic Activity of daily living (Barthel Index<100)
2) Cognitive decline (Mini Mental State Examination<24)
3) Medically advised not to participate in exercise
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisatomo Kowa
Organization Kobe University
Division name Graduate School of Health Sciences
Zip code
Address 7-10-2, Tomogaoka, Suma-ku, Kobe, Hyogo
TEL 078-796-4561
Email kowa@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rei Ono
Organization Kobe University
Division name Graduate School of Health Sciences
Zip code
Address 7-10-2, Tomogaoka, Suma-ku, Kobe, Hyogo
TEL 078-796-4545
Homepage URL
Email ono@phoenix.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Life Science Institute, Inc
Total Brain Care Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 神戸大学 名谷キャンパス

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 13 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
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 14 Day
Last follow-up date
2016 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 13 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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