UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034903 |
|---|---|
| Receipt number | 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 18:17:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
akimura753@gmail.com
Sponsor or person
Institute
Graduate School of Health Sciences kimuraakira lab
Institute
Department
Personal name
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
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
Value
https://center6.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 |
