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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027379
Receipt No. R000031370
Scientific Title Influence on blood vessels of flexible exercise intervention which is one element of physical strength.
Date of disclosure of the study information 2017/05/18
Last modified on 2019/07/06

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Basic information
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
Condition Not applicable(Adult)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization Self-procurement
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 Kansai Medical University
Address 2-5-1 Shinmachi, Hirakata, Osaka,
Tel 072-804-0101
Email hi-kota@soleil.ocn.ne.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
2017 Year 05 Month 18 Day

Related information
URL releasing protocol Japan Association of Exercise Therapy and Prevention Journal 19(2),27-31,2018
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2017 Year 05 Month 17 Day
Last modified on
2019 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031370

Research Plan
Registered date File name
2019/06/19 研究計画書.docx

Research case data specifications
Registered date File name
2019/06/19 スタティックストレッチング介入による動脈スティフネス及び血管内皮機能への効果の検討.docx

Research case data
Registered date File name
2019/06/19 スタティックストレッチング介入による動脈スティフネス及び血管内皮機能への効果の検討.docx


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