UMIN-CTR Clinical Trial

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
Email	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
Email	shimizu-tomomi@rehab.go.jp

Sponsor
Institute	National Rehabilitation Center for Persons with Disabilities(Research Institute)
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048933