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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034903
Receipt No. R000039793
Scientific Title Physical activity, diet and genetic constitution on vascular function of the elderly with R90 in healthy longevity area in Okinawa Prefecture
Date of disclosure of the study information 2019/03/31
Last modified on 2018/11/15

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Basic information
Public title Physical activity, diet and genetic constitution on vascular function of the elderly with R90 in healthy longevity area in Okinawa Prefecture
Acronym R90 in healthy longevity area in Okinawa_study
Scientific Title Physical activity, diet and genetic constitution on vascular function of the elderly with R90 in healthy longevity area in Okinawa Prefecture
Scientific Title:Acronym 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
1st name
Middle name
Last name Akira Kimura
Organization GUNMA PAZ UNIVERSITY
Division name Graduate School of Health Sciences
Zip code
Address 1-7-1 Tonya-machi Takasaki Gunma Japan
TEL 0273653366
Email kimuaki@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kimura
Organization GUNMA PAZ UNIVERSITY
Division name Gunam Paz University
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol http://kimuakilabo.main.jp/kenkyu_ogimi
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 Completed
Date of protocol fixation
2018 Year 07 Month 06 Day
Date of IRB
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

Other
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

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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