UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022678 |
|---|---|
| Receipt number | R000026102 |
| Scientific Title | Effect of change in ocular blood flow on viual function at exercise. |
| Date of disclosure of the study information | 2016/06/09 |
| Last modified on | 2016/12/12 16:11:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of change in ocular blood flow on viual function at exercise.
Acronym
Effect of change in ocular blood flow on viual function at exercise.
Scientific Title
Effect of change in ocular blood flow on viual function at exercise.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Isao MURAOKA |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima Tokorozawa Saitama
TEL
04-2947-6725
imuraoka@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukasa IKEMURA |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima Tokorozawa Saitama
TEL
04-2947-7128
Homepage URL
ikemura-t@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 07 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026102
