UMIN-CTR Clinical Trial

Public title

Influence on blood vessels of flexible exercise intervention which is one element of physical strength.

Acronym

Influence on blood vessels of flexible exercise.

Scientific Title

Influence on blood vessels of flexible exercise intervention which is one element of physical strength.

Scientific Title:Acronym

Influence on blood vessels of flexible exercise.

Region

Japan

Condition

Not applicable(Adult)

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In exercise intervention by static stretching alone, we examine the effect on blood vessels from vascular endothelial function and arteriosclerotic index. Visualize the extension state of the blood vessel at the time of stretching and verify the extension of the blood vessel from the image.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Three months and six months after the start of intervention.
sit-and-reach test, RH-PATindex, baPWV

Key secondary outcomes

2D Speckle tracking, Autonomic function, Body composition (height, weight, BMI, and body fat percentage), International Physical Activity Questionnaire short version

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

In the fullgroup, the intervention period was 6 months, with the women performing 15 minutes of static stretching at least once per day, every day. In the half group, the
women did not perform the intervention during the first 3 months (control period) but started doing the same thing as the full group did for the next 3 months.

Interventions/Control_2

In the half group, the women did not perform the intervention during the first 3 months (control period) but started doing the same thing as the full group did for the next 3 months.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

55

years-old

>=

Gender

Female

Key inclusion criteria

non-smoking, premenopausal, We defined healthy women as women with a body massindex (BMI) <25 kg/m2 and without neurological diseases,physical diseases, or lifestyle-related diseases(e.g. hypertension, hyperlipidaemia).

Key exclusion criteria

Smoking, postmenopausal, body mass index (BMI)> 25 kg / m2, with physical disorders or lifestyle diseases (eg hypertension, hyperlipidemia).

Target sample size

100

Name of lead principal investigator

1st name	Yutaka
Middle name
Last name	Kimura

Organization

Kansai Medical University Hospital

Division name

Health Science Center

Zip code

573-1010

Address

2-5-1 Shinmachi, Hirakata, Osaka,

TEL

072-804-0101

Email

kimuray@hirakata.kmu.ac.jp

Name of contact person

1st name	Hiromi
Middle name
Last name	Shinno

Organization

Kansai Medical University

Division name

Health Science

Zip code

573-1010

Address

2-5-1 Shinmachi, Hirakata, Osaka,

TEL

072-804-0101

Homepage URL

Email

hi-kota@soleil.ocn.ne.jp

Institute

Department of Health Science, Graduate School of Medicine, Kansai Medical University, Osaka, Japan

Institute

Department

Personal name

Organization

Self-procurement

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kansai Medical University

Address

2-5-1 Shinmachi, Hirakata, Osaka,

Tel

072-804-0101

Email

hi-kota@soleil.ocn.ne.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

05

Month

18

Day

URL releasing protocol

Japan Association of Exercise Therapy and Prevention Journal 19(2),27-31,2018

Publication of results

Published

URL related to results and publications

Japan Association of Exercise Therapy and Prevention Journal 19(2),27-31,2018

Number of participants that the trial has enrolled

22

Results

Flexibility evaluation did not show significant change in the waist angle of the stretch group, but long seat forward bending, SLR right, SLR left, upper back angle significantly improved recognized. The baPWV in the stretch group did not change significantly before and after the intervention. RH-PAT index, which is an index of vascular endothelial function, was significantly improved in the stretch group.

Results date posted

2019

Year

07

Month

06

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The subjects were 22 healthy women (mean age 47.4 years) who had menstruation over the age of 40 and had no smoking habit.

Participant flow

The subjects of this study, the contents of implementation and notes of the study were explained to all the subjects, and the consent was obtained in writing.
Static stretching of the following 15 sites were performed whilst standing, sitting, or lying down. The stretching duration was 20-30 seconds per site. The stretching was performed to a degree that the participant characterised as somewhat heavy to heavy on the Rating of Perceived Exertion (called Borg Scale). A calendar specifically designed to keep a record of the intervention was created, which the participants filled on their own. The rate of exercise completion was calculated by the number of interventions performed for the number of days in the intervention.

Adverse events

None.

Outcome measures

The body composition was measured. Flexibility was measured with straight leg raising and the sit-and-reach test. Straight leg raising was measured using a joint goniometer once on each side. Physical activity in a normal week was determined using the international physical activity questionnaire short version. Blood pressure was measured after urination, after 10 minutes of rest in the supine position and at two other times continuously. Brachial-ankle pulse wave velocity, an index of arterial stiffness, was measured using the vascular screening device BP-203RPE. The RH-PAT index, autonomic function and brachial-ankle pulse wave were measured in all subjects in that order on the same day. Autonomic function was evaluated by the heart rate variability of the R-R interval. Low frequency, high frequency and the LF to HF ratio were measured.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

07

Month

12

Day

Date of IRB

2017

Year

03

Month

01

Day

Anticipated trial start date

2017

Year

03

Month

09

Day

Last follow-up date

2018

Year

02

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

17

Day

Last modified on

2019

Year

07

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031370