UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018547 |
|---|---|
| Receipt number | 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 09:07:56 |
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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
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
makizako@ncgg.go.jp
Sponsor or person
Institute
Department of Preventive Gerontology, National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021462
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| Registered date | File name |
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| Registered date | File name |
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