UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036751 |
|---|---|
| Receipt number | R000041877 |
| Scientific Title | Effects of static stretching on arteriosclerosis related index and blood pressure in hypertensive patients |
| Date of disclosure of the study information | 2019/05/20 |
| Last modified on | 2022/05/16 14:24:36 |
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Basic information
Public title
Effects of static stretching on arteriosclerosis related index and blood pressure in hypertensive patients
Acronym
Effects of static stretching on arteriosclerosis related index and blood pressure in hypertensive patients
Scientific Title
Effects of static stretching on arteriosclerosis related index and blood pressure in hypertensive patients
Scientific Title:Acronym
Effects of static stretching on arteriosclerosis related index and blood pressure in hypertensive patients
Region
| Japan |
Condition
Condition
Hypertention
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In hypertensive patients, stretching recommended as locomotive syndrome prevention is continued for 10 months, and changes in vascular endothelial function, arteriosclerosis related index, and blood pressure are examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The main outcome item is the vascular endothelial function of arteriosclerosis related index. The measurements are taken 1, 3, 6, 7, 10 months before the intervention starts.
Key secondary outcomes
The secondary outcome endpoints are CAVI and blood pressure. The measurements are taken 1, 3, 6, 7, 10 months before the intervention starts.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention is for the subject to perform daily static stretching recommended as locomotive syndrome prevention.After 6 months of stretching, stop for 1 month and perform from 7 months to 10 months.Stretching consists of 10 types, and one operation takes about 30 seconds. One implementation time is about 15 minutes.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Key inclusion criteria are men and women aged 30 to 60 years of age who have been diagnosed with essential hypertension.
Key exclusion criteria
Key exclusion criteria are persons under the age of 30 and 60 years of age, persons with secondary hypertension and heart disease, persons with systolic blood pressure 180 mmHg, diastolic blood pressure 100 mmHg or more, and persons judged by the doctor as inappropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Koyama |
Organization
Niigata University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
9518518
Address
Asahimachidori 2nd Town 746 Chuo Ward Niigata City Niigata Prefecture
TEL
025-227-2361
yukmy@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Koyama |
Organization
Niigata University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
9518518
Address
Asahimachidori 2nd Town 746 Chuo Ward Niigata City Niigata Prefecture
TEL
025-227-2361
Homepage URL
yukmy@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
None
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
Asahimachidori 2nd Town 746 Chuo Ward Niigata City Niigata Prefecture
Tel
025-227-2361
yukmy@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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 20 | 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
10
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 | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 15 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041877
