UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of exercise on cognitive function in older adults with subjective cognitive impairment (SCI)
Title of the study (Brief title)	The effects of exercise on cognitive function in older adults with subjective cognitive impairment (SCI)
Region	Japan

Condition
Condition	subjective cognitive impairment (SCI)
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether physical exercise can help to prevent dementia caused by deposition of amyloid or not
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Examination of cerebrospinal fluid (amiloid beta TNFalfa IL6 IL10) Blood exam (TNFalfa WBC RBC PLT) Image Inspection (MRI SPECT) Mini Mental State Examination
Key secondary outcomes	*Clinical end-point

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	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Exercise-intervention group: aerobic exercise and resistance training 4 or more times a week for 6 months
Interventions/Control_2	Control Group:spend daily life for 6months
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	65 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	subjective cognitive impairment (SCI)patients MMSE score above 24
Key exclusion criteria	*A previous history of cerebral infarction or paralysis. The patients with cranial nerve problem *Having cardiovascular, respiratory or ophthalmologic disease *Insulin self-injection *Take Metformin or Biguanide
Target sample size	40

Research contact person
Name of lead principal investigator	Madoka Yanagawa
Organization	Nagoya University
Division name	Department of Community Healthcare & Geriatrics, Graduate School of Medicine
Address	65 Tsuruma-cho, Showa-ku, Nagoya
TEL	052-744-2364
Email	mayaka@med.nagoya-u.ac.jp

Public contact
Name of contact person	Madoka Yanagawa
Organization	Nagoya University
Division name	Healthcare & Geriatrics, Graduate School of Medicine
Address	65 Tsuruma-cho, Showa-ku, Nagoya
TEL	052-744-2364
Homepage URL
Email	mayaka@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Community Healthcare & Geriatrics, Nagoya University Graduate School of Medicine
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, Culture, Sports, Science and Technology
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 08 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 28 Day
Anticipated trial start date	2016 Year 09 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 05 Month 13 Day
Last modified on	2016 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025699