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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041877


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name