UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of change in ocular blood flow on viual function at exercise.
Title of the study (Brief title)	Effect of change in ocular blood flow on viual function at exercise.
Region	Japan

Condition
Condition	healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the change in ocular blood flow influences visual function during exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ocular blood flow and visual function in control condition, hypoventilative condition, and hyperventilative condition during exercise.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	1) measuring the maximum oxygen uptake for determination of exercise intensity. 2) wash out period over 7 days. 3) cycling exercise at 50% VO2max or 60%HRreserve is peformed for 31 min, and breathing condition (control, hyperventilation which breathing rate is set to 1.5 time, hypoventilation which breathing rate is set to 0.5 time) is performed in the meantime.
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	20 years-old <
Age-upper limit	30 years-old >
Gender	Male
Key inclusion criteria	1) healthy males of 20-30 years old.
Key exclusion criteria	1) the person who experienced any disease which indicate on a screening sheet. 2) the person who refuse participation from experimenter, because lifstyle doesn't suit in this study (e.g., smoking) and/or can't obey experimental rules.
Target sample size	15

Research contact person
Name of lead principal investigator	Isao MURAOKA
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima Tokorozawa Saitama
TEL	04-2947-6725
Email	imuraoka@waseda.jp

Public contact
Name of contact person	Tsukasa IKEMURA
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima Tokorozawa Saitama
TEL	04-2947-7128
Homepage URL
Email	ikemura-t@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Waseda University
Organization
Division
Category of Funding Organization	Other
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 06 Month 09 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 12 Month 07 Day
Anticipated trial start date	2016 Year 06 Month 13 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 09 Day
Last modified on	2016 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026102