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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018547
Receipt No. R000021462
Scientific Title Study for Decreasing Depressive Symptoms and Increasing Memory Performance in the Elderly
Date of disclosure of the study information 2015/08/07
Last modified on 2016/08/05

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Basic information
Public title Study for Decreasing Depressive Symptoms and Increasing Memory Performance in the Elderly
Acronym Effects of exercise and horticultural intervention on the brain and mental health in older adults with mild memory problems and depressive symptoms
Scientific Title Study for Decreasing Depressive Symptoms and Increasing Memory Performance in the Elderly
Scientific Title:Acronym Effects of exercise and horticultural intervention on the brain and mental health in older adults with mild memory problems and depressive symptoms
Region
Japan

Condition
Condition depressive symptoms, mild memory problems
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to identify the effects of physical exercise and horticultural intervention on the brain and mental health in older adults with mild memory problems and depressive symptoms.
Basic objectives2 Others
Basic objectives -Others The mixed effect model and generalized linear model with intention-to-treat analysis are performed to examine the effects of intervention program
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes (1) depressive symptoms at post intervention (6 month)
(2) memory performance at post intervention (6 month)
Key secondary outcomes (1) cognitive function (attention, executive function, processing speed, etc.)
(2) neuroimaging data
(3) physical performance and physical activity
(4) psychological outcomes
(5) biomarker

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 exercise group: once-weekly exercise program for 20 weeks
Interventions/Control_2 horticultural group: once-weekly horticultural program for 20 weeks
Interventions/Control_3 Control group: educational class
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

Not applicable
Gender Male and Female
Key inclusion criteria Subject who fulfill the following all criteria
(1) Independent adults aged 65 years and older living within the community
(2) memory problems (a. or b.): a. objective mild memory decline (indicated by an age- and education-adjusted score at least 1.0 SDs below the reference threshold), b. subjective memory complaint
(3) depressive symptoms (Geriatric Depression Scale >=5)
Key exclusion criteria (1) dementia diagnosis
(2) serious neurological or musculoskeletal diagnoses, such as Parkinson's disease, depression, and others
(3) Mini-Mental State Examination score 18 and below
(4) incapable of taking cognitive performance tests
(5) contraindications of physical exercise
(6) Use of walking aids in daily life
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hyuma Makizako
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
Address 7-430 Morioka-cho, Obu, Aichi, Japan
TEL 0562-46-2311
Email makizako@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hyuma Makizako
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
Address 7-430 Morioka-cho, Obu, Aichi, Japan
TEL 0562-46-2311
Homepage URL
Email makizako@ncgg.go.jp

Sponsor
Institute Department of Preventive Gerontology, National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization a Grant-in-Aid for Young Scientists (A) (No. 26702033)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 国立長寿医療研究センター

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 07 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 Enrolling by invitation
Date of protocol fixation
2015 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 27 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 11 Month 30 Day
Date analysis concluded
2018 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 05 Day
Last modified on
2016 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021462

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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