UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033183 |
|---|---|
| Receipt number | R000037838 |
| Scientific Title | preventive effect of exercise therapy for age-related macular degeneration |
| Date of disclosure of the study information | 2018/06/29 |
| Last modified on | 2018/06/28 16:49:09 |
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Basic information
Public title
preventive effect of exercise therapy for age-related macular degeneration
Acronym
preventive effect of exercise therapy for age-related macular degeneration
Scientific Title
preventive effect of exercise therapy for age-related macular degeneration
Scientific Title:Acronym
preventive effect of exercise therapy for age-related macular degeneration
Region
| Japan |
Condition
Condition
age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether endothelial function improvement by exercise therapy reduces frequency of antivascular endothelial growth factor (anti-VEGF) treatment for neovascular age-related macular degeneration (nAMD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of anti-VEGF treatments for two years
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
At least 4 times a week for two years of interval walking training as exercise therapy. Interval walking training takes 15 minutes a day.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who has been underwent anti-VEGF monotherapy
patients whose visual acuity of one eye is better than 0.4
Key exclusion criteria
patients with a history of photodynamic therapy
patients who have difficulty in walking
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Hayashi |
Organization
Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name
Department of Ophthalmology
Zip code
Address
2630 Sugitani, Toyama 930-0194, Japan
TEL
0764347363
ganka@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Ueda-Consolvo |
Organization
Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name
Department of Ophthalmology
Zip code
Address
2630 Sugitani, Toyama 930-0194, Japan
TEL
0764347363
Homepage URL
ganka@med.u-toyama.ac.jp
Sponsor or person
Institute
Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
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
| 2018 | Year | 06 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | 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
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037838
