UMIN-CTR Clinical Trial

Basic information
Public title	Community intervention research of health promotion for the elderly
Acronym	Community intervention research of health promotion for the elderly
Scientific Title	Community intervention research of health promotion for the elderly
Scientific Title:Acronym	Community intervention research of health promotion for the elderly
Region	Japan

Condition
Condition	elderly
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Search for biomarkers related to dementia, frailty syndrome, and age-related diseases in the elderly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Biomarker after 18 months
Key secondary outcomes	MMSE

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Weekly exercise, diet, cognitive training
Interventions/Control_2	Daily yogurt intake
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	75 years-old <=
Age-upper limit	83 years-old >
Gender	Male and Female
Key inclusion criteria	Residents living at home in the Ajisu area
Key exclusion criteria	MMSE Less than 23 Residents who are certified as requiring nursing care 2 or more
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Tanabe
Organization	Yamaguchi University Faculty of Medicine and Health Sciences
Division name	Public health
Zip code	755-8505
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL	0836-22-2231
Email	tanabe@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Ryosuke Middle name Last name Hase
Organization	Yamaguchi University Faculty of Medicine and Health Sciences
Division name	Public health
Zip code	755-8505
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL	0836-22-2231
Homepage URL
Email	ryosuke-hase@umin.ac.jp

Sponsor
Institute	Yamaguchi University
Institute
Department

Funding Source
Organization	Self-procurement
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center For Clinical Research, Yamaguchi University Hospital
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
Tel	0836-22-2428
Email	me223@yamaguchi-u.ac.jp

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	2021 Year 05 Month 20 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	101
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	No longer recruiting
Date of protocol fixation	2021 Year 01 Month 24 Day
Date of IRB	2021 Year 01 Month 24 Day
Anticipated trial start date	2021 Year 01 Month 24 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 20 Day
Last modified on	2021 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050541