UMIN-CTR Clinical Trial

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
Email	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
Email	yukmy@clg.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041877