UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for Decreasing Depressive Symptoms and Increasing Memory Performance in the Elderly
Title of the study (Brief title)	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	Hyuma Makizako
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Preventive Gerontology
Address	7-430 Morioka-cho, Obu, Aichi, Japan
TEL	0562-46-2311
Email	makizako@ncgg.go.jp

Public contact
Name of contact person	Hyuma Makizako
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Preventive Gerontology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 06 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021462