UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Physical activity, diet and genetic constitution on vascular function of the elderly with R90 in healthy longevity area in Okinawa Prefecture
Title of the study (Brief title)	R90 in healthy longevity area in Okinawa_study
Region	Japan

Condition
Condition	Arteriosclerosis
Classification by specialty	Cardiology Geriatrics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	IWe clarify the influence of the magnitude of the movement ability on the degree of hardening of the aorta - radial artery in stratified manner in elderly people who are self - supporting over 90 years of age living in Ogimi village for over 40 years.
Basic objectives2	Others
Basic objectives -Others	To clarify the effects of physical activity and the genetic predisposition in the same residents and to clarify the combined effect of health promotion related factors that helps to maintain optimal vascular function under each condition.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Aorta-Radial Pulse Wave Propagation Velocity (PWV)
Key secondary outcomes	It is regarded as superiority (frequency) of health literacy. Outcomes are PWV meal related factors: pre-war and post-war meal contents (3 foods eaten most in a week), spam intake frequency (average intake consumed in one week), non-spam protein sources Physical activity related factor: Measurement of one leg standing time, Grip strength, Body composition (body weight, body fat mass, muscle mass, bone mass rate), chair standing position (average body weight, average intakes consumed in one week) Obtain repeated test results. As a genetic constitution, an individual in the oral epithelial tissue piece was sampled with a cotton bud, and polymorphism (SNP) information of Actinin 3 (ACTN 3), ACE gene, PGC-1alfa protein (PPARGC 1 A) by the gene analysis company

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	88 years-old <
Age-upper limit	110 years-old >=
Gender	Male and Female
Key inclusion criteria	Walking is independent.
Key exclusion criteria	They have to be in and out of the hospital within one year.
Target sample size	20

Research contact person
Name of lead principal investigator	Akira Kimura
Organization	GUNMA PAZ UNIVERSITY
Division name	Graduate School of Health Sciences
Address	1-7-1 Tonya-machi Takasaki Gunma Japan
TEL	0273653366
Email	kimuaki@nifty.com

Public contact
Name of contact person	Akira Kimura
Organization	GUNMA PAZ UNIVERSITY
Division name	Gunam Paz University
Address	1-7-1 Tonya-machi Takasaki Gunma Japan
TEL	08051153631
Homepage URL	http://kimuakilabo.main.jp/kenkyu_ogimi
Email	akimura753@gmail.com

Sponsor
Institute	Graduate School of Health Sciences kimuraakira lab
Institute
Department

Funding Source
Organization	Gunma Paz University Reserch Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	GUNMA PAZ UNIVERSITY

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

Secondary IDs
Secondary IDs	YES
Study ID_1	18-29
Org. issuing International ID_1	PAZ18-23
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	沖縄県大宜味村社会福祉協議会（沖縄県）、群馬パ―ス大学（群馬県）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 06 Day
Anticipated trial start date	2018 Year 08 Month 06 Day
Last follow-up date	2018 Year 09 Month 15 Day
Date of closure to data entry	2018 Year 11 Month 30 Day
Date trial data considered complete	2018 Year 12 Month 20 Day
Date analysis concluded	2019 Year 01 Month 16 Day

Related information
URL releasing protocol	http://kimuakilabo.main.jp/kenkyu_ogimi
Publication of results	Unpublished
URL releasing results
Results
Other related information	Observation Study

Management information
Registered date	2018 Year 11 Month 15 Day
Last modified on	2018 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039793