UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021283 |
|---|---|
| Receipt number | R000024548 |
| Scientific Title | Effect of exercise on ocular arterial function in healthy subjects. |
| Date of disclosure of the study information | 2016/03/02 |
| Last modified on | 2024/04/15 14:49:04 |
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Basic information
Public title
Effect of exercise on ocular arterial function in healthy subjects.
Acronym
Effect of exercise on ocular arterial function in healthy subjects.
Scientific Title
Effect of exercise on ocular arterial function in healthy subjects.
Scientific Title:Acronym
Effect of exercise on ocular arterial function in healthy subjects.
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To evaluate the ocular arterial function.
2) To investigate whether the aerobic exercise influences the ocular arterial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Index of pulse wave analysis from ocular blood flow velocity (BOT, BOS, Skew, rising rate, falling rate) at rest.
2) Index of pulse wave analysis from ocular blood flow velocity (BOT, BOS, Skew, rising rate, falling rate) before exercise and after exercise at 0, 15, 30, 45 and 60 min.
3) Index of pulse wave analysis from ocular blood flow velocity (BOT, BOS, Skew, rising rate, falling rate) before exercise training and after exercise training at 5 and 10 week.
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) A bout of cycling exercise at 60% HRreserve.
2) Cycling exercise at 60% HRreserve 3 times a week per 10 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The person who does not have chronic desease.
2) Agreement with this study after explanation.
3) The training situation does not change during experiment.
4) The eating situation does not during experiment.
Key exclusion criteria
1) The person who restricted exercise from a doctor.
2) The person who pointed out abnormal electrocardiogram and heart disease from a doctor.
3) A brain concussion and disturbance of consciousness have been experienced in the past.
4) The person who experienced kawasaki disease and rtheumatic fever in present or the past.
5) The person who experienced any ocular disease in present or the past.
6) The person who experienced chest pain during exercise.
7) The person who had medical examination or medical treatment of anemia from a doctor.
Target sample size
108
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Ikemura |
Organization
Kitasato University
Division name
College of Liberal Arts and Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8749
ikemura@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Ikemura |
Organization
Kitasato University
Division name
College of Liberal Arts and Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788749
Homepage URL
ikemura@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Grants-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Reserch Support Center
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8894
kenkyu@kitasato-u.ac.jp
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 | 02 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 02 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024548
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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