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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033183
Receipt No. 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

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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
Email 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
Email ganka@med.u-toyama.ac.jp

Sponsor
Institute Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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