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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008103
Receipt No. R000009537
Scientific Title The beneficial effect of a short term combination exercise training on cognitive functions and mental health in the healthy middle and older women
Date of disclosure of the study information 2012/06/05
Last modified on 2015/12/05

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Basic information
Public title The beneficial effect of a short term combination exercise training on cognitive functions and mental health in the healthy middle and older women
Acronym The beneficial effect of combination exercise training on cognitive functions and mental health in the healthy middle and older women
Scientific Title The beneficial effect of a short term combination exercise training on cognitive functions and mental health in the healthy middle and older women
Scientific Title:Acronym The beneficial effect of combination exercise training on cognitive functions and mental health in the healthy middle and older women
Region
Japan

Condition
Condition healthy middle and older women
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 a short term combination exercise training on cognitive functions and mental health in women.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stroop Test (ST)
Key secondary outcomes Verbal fluency task (VFT)
Logical Memory (LM)
First and Second Names (FS-N)
Digit Span Forward (DS-F)
Digit span Backward (DS-B)
Japanese Reading Test (JART)
Digit Cancellation Task (D-CAT)
Digit Symbol Coding (Cd)
Symbol Search (SS)
WHO-QOL26
SUBI
GHQ12

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The intervention group participate in a combination exersice intervention in 4 weeks.
Interventions/Control_2 The wait listed group does not participate in the intervention.
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
40 years-old <=
Age-upper limit
75 years-old >
Gender 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 We exclude participants who will have IQ less than 85 derived from JART. Participants who will participate in another execise-related training.
Target sample size 64

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 022-717-7988
Email rnouchi@idac.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nouchi Rui
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 Tohoku University
Institute
Department

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
2012 Year 06 Month 05 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
2012 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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
2012 Year 06 Month 05 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=R000009537

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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