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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028266
Receipt No. 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

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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
Institute Tokyo Institute of Technology
Institute
Department

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
URL(English) https://upload.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


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