UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of exercise on brain activity during walking in older adults
Title of the study (Brief title)	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

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
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

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	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	Hiroyuki Shimada
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Promoting Independence of the Elderly
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	Hiroyuki Shimada
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Preventive Gerontology
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

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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000025164