UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027740 |
|---|---|
| Receipt number | 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 12:29:35 |
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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
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
ono@phoenix.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031784
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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