UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of long-term use of massage roller on arterial reactivity
Title of the study (Brief title)	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	HAYASHI, Naoyuki
Organization	Tokyo Institute of Technology
Division name	Institute for Liberal Arts
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	HAYASHI, Naoyuki
Organization	Tokyo Institute of Technology
Division name	Institute for Liberal Arts
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032352