UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the effect of high-intensity interval walking for the retinal vessel narrowing
Title of the study (Brief title)	The effct of high-intensity interval walking for the retinal vessels
Region	Japan

Condition
Condition	healthy adult lifestyle-related disease
Classification by specialty	Medicine in general Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of high-intensity interval walking for the retinal vessel diameters.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of retinal vessel diameters
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	High-intensity interval walking (over 6 months)
Interventions/Control_2	Without high-intensity interval walking
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	50 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Older person who attends newly high-intensity interval walking. 2)Those who have no difficulty in the walking. 3)Those who have no retinal disease.
Key exclusion criteria	None
Target sample size	30

Research contact person
Name of lead principal investigator	Kouichi Ohta
Organization	Matsumoto Dental University
Division name	Ophthalmology
Address	1780 Gobara, Hirooka, Shiojiri
TEL	0263-51-2210
Email	ohta@po.mdu.ac.jp

Public contact
Name of contact person	Kouichi Ohta
Organization	Matsumoto Dental University
Division name	Ophthalmology
Address	1780 Gobara, Hirooka, Shiojiri
TEL	0263-51-2210
Homepage URL
Email	ohta@po.mdu.ac.jp

Sponsor
Institute	Matsumoto Dental University
Institute
Department

Funding Source
Organization	Matsumoto Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 05 Month 01 Day
Anticipated trial start date	2014 Year 05 Month 19 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 16 Day
Last modified on	2016 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016125