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Recruitment status Completed
Unique ID issued by UMIN UMIN000019832
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email rnouchi@idac.tohoku.ac.jp

Sponsor
Institute Tohoku university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022912


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