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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022306
Receipt No. R000025699
Scientific Title The effects of exercise on cognitive function in older adults with subjective cognitive impairment (SCI)
Date of disclosure of the study information 2016/08/28
Last modified on 2016/05/13

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Basic information
Public title The effects of exercise on cognitive function in older adults with subjective cognitive impairment (SCI)
Acronym The effects of exercise on cognitive function in older adults with subjective cognitive impairment (SCI)
Scientific Title The effects of exercise on cognitive function in older adults with subjective cognitive impairment (SCI)
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Madoka Yanagawa
Organization Nagoya University
Division name Department of Community Healthcare & Geriatrics, Graduate School of Medicine
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya
TEL 052-744-2364
Email mayaka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Madoka Yanagawa
Organization Nagoya University
Division name Healthcare & Geriatrics, Graduate School of Medicine
Zip code
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

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)

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 08 Month 28 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 28 Day
Date of IRB
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

Other
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

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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