UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042869 |
|---|---|
| Receipt number | R000048933 |
| Scientific Title | Improvement of psychosocial function brought by exercise intervention on visually impaired persons and the development of exercise support program |
| Date of disclosure of the study information | 2020/12/29 |
| Last modified on | 2022/06/29 09:11:34 |
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Basic information
Public title
Improvement of psychosocial function brought by exercise intervention on visually impaired persons and the development of exercise support program
Acronym
Improvement of psychosocial function brought by exercise intervention on visually impaired persons and the development of exercise support program
Scientific Title
Improvement of psychosocial function brought by exercise intervention on visually impaired persons and the development of exercise support program
Scientific Title:Acronym
Improvement of psychosocial function brought by exercise intervention on visually impaired persons and the development of exercise support program
Region
| Japan |
Condition
Condition
Visually impaired
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of exercise intervention programs for the visually impaired on psychosocial functions and develop exercise support programs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 and VFQ-25
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
| Other |
Interventions/Control_1
Perform 8 weeks of exercise intervention.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Either "Corrected visual acuity of the better eye is less than 0.5" or
"Scotoma or defect in the visual field" is satisfied.
Key exclusion criteria
Mental disorders caused by mental illnesses such as intellectual disability, developmental disability, and schizophrenia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Nishida-Shimizu |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
Hospital, Dept of Medical Treatment(2), (Research Institute)
Zip code
3598555
Address
Namiki, 4-1, Tokorozawa, Saitama
TEL
0429953100
shimizu-tomomi@rehab.go.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Nishida-Shimizu |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
Hospital, Dept of Medical Treatment(2), (Research Institute)
Zip code
3598555
Address
Namiki, 4-1, Tokorozawa, Saitama
TEL
0429953100
Homepage URL
shimizu-tomomi@rehab.go.jp
Sponsor or person
Institute
National Rehabilitation Center for Persons with Disabilities(Research Institute)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Rehabilitation Center for Persons with Disabilities
Address
Namiki, 4-1, Tokorozawa, Saitama
Tel
0429953100
kikakurinnri@mhlw.go.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
| 2020 | Year | 12 | 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
30
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
| 2020 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 07 | 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
| 2020 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048933
