UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022306 |
|---|---|
| Receipt number | 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 21:21:05 |
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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
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
mayaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Community Healthcare & Geriatrics, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
