UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050551
Receipt number R000057567
Scientific Title The immediate hemodynamic effects of different stretching durations on hemodynamics
Date of disclosure of the study information 2023/03/09
Last modified on 2024/03/13 10:22:41

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Basic information

Public title

The effect of different stretching methods on hemodynamics

Acronym

The effect of stretching on hemodynamics

Scientific Title

The immediate hemodynamic effects of different stretching durations on hemodynamics

Scientific Title:Acronym

The effect of stretching of different durations on hemodynamics

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the hemodynamic effects of different stretching durations in healthy young men.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hemodynamics of conduit arteries (measured from pre-stretch to 10 min post-stretch)

Key secondary outcomes

Microvascular hemodynamics (measured from pre-stretch to 10 min post-stretch)
Systemic hemodynamics (measured from pre-stretch to 10 min post-stretch)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Repeat 3 sets of stretching for 60 seconds

Interventions/Control_2

Repeat 6 sets of stretching for 30 seconds

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

18 years-old <=

Age-upper limit

30 years-old >=

Gender

Male

Key inclusion criteria

No history of cardiovascular disease
Patients who are not on any drug therapy
No regular exercise habits.

Key exclusion criteria

Patients with a history of cardiovascular disease or on drug therapy.
Those who have a regular exercise routine (less than 150 minutes of moderate aerobic exercise or less than 75 minutes of high intensity aerobic exercise per week).
Other persons deemed inappropriate as research subjects by the principal investigator.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Hajime
Middle name
Last name Tamiya

Organization

Niigata University of Health and Welfare

Division name

Department of Physical Therapy

Zip code

9503198

Address

1398 Shimami-cho, Kita-ku, Niigata City, Niigata

TEL

0252574723

Email

tamiya@nuhw.ac.jp


Public contact

Name of contact person

1st name Hajime
Middle name
Last name Tamiya

Organization

Niigata University of Health and Welfare

Division name

Department of Physical Therapy

Zip code

9503198

Address

1398 Shimami-cho, Kita-ku, Niigata City, Niigata

TEL

0252574723

Homepage URL


Email

tamiya@nuhw.ac.jp


Sponsor or person

Institute

Niigata University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Other

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee, Niigata University of Health and Welfare

Address

1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata

Tel

0252574455

Email

rinri@nuhw.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

2023 Year 03 Month 09 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


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

No longer recruiting

Date of protocol fixation

2023 Year 02 Month 01 Day

Date of IRB

2023 Year 03 Month 10 Day

Anticipated trial start date

2023 Year 03 Month 13 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 03 Month 09 Day

Last modified on

2024 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057567