UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028266
Receipt number R000032352
Scientific Title Effect of long-term use of massage roller on arterial reactivity
Date of disclosure of the study information 2017/07/19
Last modified on 2018/07/19 14:04:14

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Basic information

Public title

Effect of long-term use of massage roller on arterial reactivity

Acronym

Effect of long-term use of massage roller on arterial reactivity

Scientific Title

Effect of long-term use of massage roller on arterial reactivity

Scientific Title:Acronym

Effect of long-term use of massage roller on arterial reactivity

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We reported a 20-min increase in facial blood flow after massage roller application (2016). Also, massage is known to increases flow-mediated dilatation (Franklin et al. 2014). We aimed to examine the hypothesis that long-term use of massage roller on muscles increases flow mediated dilatation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Flow mediated dilatation (FMD) and an increase response to skin temperature after 2 month massage

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Everyday usage of massage roller for muscles on forearm for 10 min with ad lib rate of massage.

Interventions/Control_2

Everyday usage of massage roller for skin (face) on forearm for 10 min with ad lib rate of massage.

Interventions/Control_3

Control. No massage roller usage.

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

40 years-old >=

Gender

Male

Key inclusion criteria

Healthy males,

Key exclusion criteria

Those who have received hand or apparatus massage on arm more than one month.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name HAYASHI, Naoyuki

Organization

Tokyo Institute of Technology

Division name

Institute for Liberal Arts

Zip code


Address

2-12-1-W9-1, Ookayama, Meguro Tokyo 1528552, Japan

TEL

0357343434

Email

naohayashi@ila.titech.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name HAYASHI, Naoyuki

Organization

Tokyo Institute of Technology

Division name

Institute for Liberal Arts

Zip code


Address

2-12-1-W9-1, Ookayama, Meguro Tokyo 1528552, Japan

TEL

0357343434

Homepage URL


Email

naohayashi@ila.titech.ac.jp


Sponsor or person

Institute

Tokyo Institute of Technology

Institute

Department

Personal name



Funding Source

Organization

MTG Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

東京工業大学(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 19 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

Completed

Date of protocol fixation

2017 Year 02 Month 20 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 29 Day

Last follow-up date

2017 Year 09 Month 29 Day

Date of closure to data entry

2017 Year 11 Month 10 Day

Date trial data considered complete

2018 Year 03 Month 10 Day

Date analysis concluded

2018 Year 04 Month 15 Day


Other

Other related information



Management information

Registered date

2017 Year 07 Month 18 Day

Last modified on

2018 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032352


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name