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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048933


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name