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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032211
Receipt No. R000024604
Scientific Title The influence that body flexibility of the woman hypertensive gives to an arteriosclerosis degree, blood pressure and health related QOL.
Date of disclosure of the study information 2018/04/12
Last modified on 2019/08/16

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Basic information
Public title The influence that body flexibility of the woman hypertensive gives to an arteriosclerosis degree, blood pressure and health related QOL.
Acronym The influence that body flexibility of the woman hypertensive gives to an arteriosclerosis degree, blood pressure and health related QOL.
Scientific Title The influence that body flexibility of the woman hypertensive gives to an arteriosclerosis degree, blood pressure and health related QOL.
Scientific Title:Acronym The influence that body flexibility of the woman hypertensive gives to an arteriosclerosis degree, blood pressure and health related QOL.
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 I clarify an association between body flexibility and an arterial stiffness of the woman hypertensive.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Arterial Stiffness
I estimate in cardio ankle vascular index(CAVI).I want to measure twice before and 3 months after intervention.
Key secondary outcomes Blood pressure
To evaluate the home blood pressure before and 3 months after the intervention.

HRQOL
I evaluate the SF36.I want to measure twice before and 3 months after intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group
I think with the patient by using the brochure a method of enhancing the flexibility of the body.Patients will be three months practicing the movement and behavior to increase the flexibility.
Interventions/Control_2 Control group
Patients live as usual.
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
40 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria People who have been diagnosed with hypertension.The person who obtained the study participants permission from the doctor
Key exclusion criteria Secondary hypertension,Arteriosclerosis obliterans,arrhythmia,heart failure,Cancer,kidney failure,Cirrhosis of the liver,Myocardial infarction,Heart disease,Infection,People without the permission of the doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Etsuko
Middle name
Last name Yamada
Organization Niigata University(graduate school)
Division name hagiko Aoki laboratory
Zip code 950-2162
Address Niigata city west district Ikarashinakajima 3-13-5
TEL 090-2462-7029
Email b15n009b@mail.cc.niigata-u.ac.jp

Public contact
Name of contact person
1st name Etsuko
Middle name
Last name Yamada
Organization niigata uniersity
Division name hagiko Aoki labolatory
Zip code 951-8122
Address Niigata Chuo-ku Asahicho 2-746
TEL 025(227)2355
Homepage URL
Email b15n009b@mail.cc.niigata-u.ac.jp

Sponsor
Institute niigata university
Institute
Department

Funding Source
Organization niigata university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Niigata University
Address 746 Asahimachidori, Chuo-ku, Niigata
Tel 025-227-2355
Email hagi@clg.niigata-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 井上内科医院(新潟県)
前田内科医院(新潟県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 12 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
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
2016 Year 03 Month 01 Day
Date of IRB
2016 Year 03 Month 01 Day
Anticipated trial start date
2016 Year 03 Month 08 Day
Last follow-up date
2016 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 12 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024604

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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