UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of exercise on structure and blood flow of choroid in normal subjects
Title of the study (Brief title)	Effect of exercise on structure and blood flow of choroid
Region	Japan

Condition
Condition	retinal and choroidal disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To obtain information on the structure and blood flow of the choroid
Basic objectives2	Others
Basic objectives -Others	Exercise-induced changes in the choroidal sturucture on EDI-OCT images and the choroidal blood flow evaluated with laser speckle flow graphy (LSFG)
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Choroidal structure on EDI-OCT images with image processing
Key secondary outcomes	Choroidal blood flow evaluated with Laser speckle flow graphy

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	For each subject, optical coherence tomography and laser speckle flowgraphy are performed before, immediatly after, and 10 minutes after 90 seconds of isometric excecise using Master two-step test.
Interventions/Control_2
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects without ocular and systemic diseases
Key exclusion criteria	Subjects with any ocular or systemic diseases
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroko Imaizumi
Organization	Sappro City General Hospital
Division name	Department of ophthalmology
Address	1-1, North 11, West 13, Chuoku, Sapporo, 060-8604, Japan
TEL	+81-11-726-2211
Email	hiroko.imaizumi@doc.city.sapporo.jp

Public contact
Name of contact person	Takamasa Kinoshita
Organization	Sappro City General Hospital
Division name	Department of ophthalmology
Address	1-1, North 11, West 13, Chuoku, Sapporo, 060-8604, Japan
TEL	+81-11-726-2211
Homepage URL
Email	knst129@gmail.com

Sponsor
Institute	Sappro City General Hospital
Institute
Department

Funding Source
Organization	Sappro City General Hospital
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	2016 Year 03 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 10 Day
Anticipated trial start date	2016 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Cross-sectional, interventional study. Enrolling by invitation (outpatients are not recruited publicly). Examination: EDI-OCT,Laser speckle Flow Graphy, Intraocular pressure, Blood pressure, Heart rate, Axial length and refractive error of the eye

Management information
Registered date	2016 Year 03 Month 11 Day
Last modified on	2017 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024716