UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021434 |
|---|---|
| Receipt number | R000024716 |
| Scientific Title | Effect of exercise on structure and blood flow of choroid in normal subjects |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2017/01/25 13:37:15 |
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Basic information
Public title
Effect of exercise on structure and blood flow of choroid in normal subjects
Acronym
Effect of exercise on structure and blood flow of choroid
Scientific Title
Effect of exercise on structure and blood flow of choroid in normal subjects
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroko Imaizumi |
Organization
Sappro City General Hospital
Division name
Department of ophthalmology
Zip code
Address
1-1, North 11, West 13, Chuoku, Sapporo, 060-8604, Japan
TEL
+81-11-726-2211
hiroko.imaizumi@doc.city.sapporo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamasa Kinoshita |
Organization
Sappro City General Hospital
Division name
Department of ophthalmology
Zip code
Address
1-1, North 11, West 13, Chuoku, Sapporo, 060-8604, Japan
TEL
+81-11-726-2211
Homepage URL
knst129@gmail.com
Sponsor or person
Institute
Sappro City General Hospital
Institute
Department
Personal name
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)
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 | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024716
