UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032211 |
|---|---|
| Receipt number | 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 05:07:45 |
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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
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
b15n009b@mail.cc.niigata-u.ac.jp
Sponsor or person
Institute
niigata university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024604
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