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Recruitment status Completed
Unique ID issued by UMIN UMIN000011858
Receipt No. R000013863
Scientific Title Effects of the working memory training combined with aerobic exercise
Date of disclosure of the study information 2013/09/25
Last modified on 2015/12/05

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Basic information
Public title Effects of the working memory training combined with aerobic exercise
Acronym Effects of the working memory training combined with aerobic exercise
Scientific Title Effects of the working memory training combined with aerobic exercise
Scientific Title:Acronym Effects of the working memory training combined with aerobic exercise
Region
Japan

Condition
Condition The healthy elderly
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the beneficial effects of the working memory training combined with aerobic exercise on cognitive functions and brain structure and functions in the elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical measures, Raven matrix test, digit span, story memory, Digit Symbol Coding (Cd) , Symbol Search(SS), digit cancellation test, S-A creativity test, MMSE, FAB, Locus of control,self self efficasy, sence of selg, self hadicapping, QOL, Falls efficacy scale-international FES-I, Groningen activity restriction scale SGARS, MRI
Key secondary outcomes

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 -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Behavior,custom Other
Interventions/Control_1 aerobic exercise using recumbent bike
Interventions/Control_2 working memory training
Interventions/Control_3 working memory training during aerobic exercise using recumbent bike
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
65 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria We include participants who will report to be right-handed, native Japanese speakers, not concerned about their own memory functions, not using medications known to interfere with cognitive functions (including benzodiazepines, antidepressants or other central nervous agents), and having no diseases known to affect the central nervous system, including thyroid disease, multiple sclerosis, Parkinson's disease, stroke, severe hypertension or diabetes.
Key exclusion criteria 1.Person who has metal in the body(ex. a pacemaker, an aneurysm clip)
2.Person without medical history of the cerebral nerve disease
3.Person without medical history such as high blood pressure, the diabetes
4.Person who is participating in another cognitive-related training
5.Person who can not walk without walking aid
6.Person who has a smoke
7.Person who has claustrophobia
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rui Nouchi
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Smart Aging International Research Center
Zip code
Address Seiryo-machi 4-1, Aoba-ku Sendai
TEL 022-717-8585
Email rnouchi@idac.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rui Nouchi
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Smart Aging International Research Center
Zip code
Address Seiryo-machi 4-1, Aoba-ku Sendai
TEL 022-717-7988
Homepage URL
Email rnouchi@idac.tohoku.ac.jp

Sponsor
Institute Institute of Development, Aging and Cancer, 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
2013 Year 09 Month 25 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
2013 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 25 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
2013 Year 09 Month 25 Day
Last modified on
2015 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013863


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