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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021829
Receipt No. R000025164
Scientific Title Effects of exercise on brain activity during walking in older adults
Date of disclosure of the study information 2016/04/10
Last modified on 2016/04/07

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Basic information
Public title Effects of exercise on brain activity during walking in older adults
Acronym Effects of exercise on brain activity
Scientific Title Effects of exercise on brain activity during walking in older adults
Scientific Title:Acronym Effects of exercise on brain activity
Region
Japan

Condition
Condition Healthy older adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study investigated the effects of physical exercise on brain activity during walk in the healthy older adults using positron emission tomography and [18F]fluorodeoxyglucose (FDG PET) for quantitative and objective evaluation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Regional cerebral glucose metabolism after 3 months.
Key secondary outcomes Walking speed, step length, and cadence

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
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise
Interventions/Control_2 Physical therapy
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
75 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Inclusion criteria was older women aged 75 years and over who were registered our database.
Key exclusion criteria Exclusion criteria were history of neurological or psychiatric disorders, cardiovascular disease, hypertension, heart failure, diabetes mellitus, head trauma, drug or alcohol abuse, or severe pain, low cognitive function (i.e., Mini Mental State Examination score < 27 points), multiple medications, drug allergy, gait disturbance, and presence of signal intensities or brain atrophy on MRI.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Shimada
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Promoting Independence of the Elderly
Zip code
Address 35-2 Sakae-cho,Itabashi-ku,Tokyo,173-0015,Japan
TEL 03-3964-3241
Email shimada@tmig.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Shimada
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
Address 7-430 Morioka-cho, Obu, Aichi, Japan, 484-8511
TEL 0562-44-5651
Homepage URL
Email shimada@ncgg.go.jp

Sponsor
Institute Ministry of Education and Culture of Japan
Institute
Department

Funding Source
Organization Ministry of Education and Culture of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 04 Month 10 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
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 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
2016 Year 04 Month 07 Day
Last modified on
2016 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025164

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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