UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019832 |
|---|---|
| Receipt number | R000022912 |
| Scientific Title | Effects of learning therapy on cognitive functions in the elderly after surgery |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2018/08/13 10:49:44 |
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Basic information
Public title
Effects of learning therapy on cognitive functions in the elderly after surgery
Acronym
learning therapy and the erlderly after surgery
Scientific Title
Effects of learning therapy on cognitive functions in the elderly after surgery
Scientific Title:Acronym
learning therapy and the erlderly after surgery
Region
| Japan |
Condition
Condition
elderly after surgery
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the beneficial effects of learning therapy on cognitive function in the elderly after surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cogstate Brief Battery(12 weeks after intervention)
Key secondary outcomes
FAB
MMSE
Cd
SS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
simple calculation and reading aloud intervention(2-5 times 20 minutes training per a week for 12 weeks)
Interventions/Control_2
No intervention groups
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese elderly who have pneumoresection (general anesthesia 2-8 hours) and is right handed
Key exclusion criteria
over 8 hours general anesthesia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Kawashima |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
Address
Seicyo-cho 4-1, Aob-ku, Sendai city
TEL
022-717-7988
rnouchi@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rui Nouchi |
Organization
Frontier Research Institute for Interdisciplinary Science (FRIS), Tohoku University
Division name
Institute of Development, Aging and Cancer, Tohoku University
Zip code
Address
Seiryo-machi 4-1, Aoba-ku Sendai city
TEL
022-717-7988
Homepage URL
rnouchi@idac.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
Tohoku university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2018 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022912
