UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Factors that encourage physical activity associated with health-related indicators in the visually impaired elderly
Title of the study (Brief title)	Health promotion blind challenge study
Region	Japan

Condition
Condition	visually impaired
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the factors of physical activity performance and health behaviour that allows easily in elderly visually impaired.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Primary outcomes are"VAS of the uneasy feeling" and force plate force,foot pressure distribution during half squatting,at six months time after the intervention.
Key secondary outcomes	Secondary outcomes are vascular stiffness,health screening items(QALYs,SF8),baPWV,venous oxygenation index value,at six months time after the intervention.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Treatment A:It gives the feedback (FB) during a half squat physical activity .FB are "Understanding cues used in operations performed" , the operation direction of the image, the influence of the speed of operation, the use of the sign of the recurring timing operating conditions. (1day) It will be washing out during 3 months. Treatment B:It gives no FB during a half squat physical activity . (1day).
Interventions/Control_2	Treatment B:It gives no FB during a half squat physical activity . FB are "Understanding cues used in operations performed" , the operation direction of the image, the influence of the speed of operation, the use of the sign of the recurring timing operating conditions. (1day). It will be washing out during 3 months. Treatment A:It gives the feedback (FB) during a half squat physical activity . (1day)
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	45 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion criteria is that it be performed by self-sitting position, standing in the spatial coordinates are obvious place and the environment that do not need a visual information. That the indication of the direction of the operation by the voice is audible.
Key exclusion criteria	If exclusion criteria that can not be stood without support 30 seconds or more, when the reaction with respect to the direction of the verbal instructions of operation is clearly ambiguous, the following persons for one year from the onset of cerebrovascular disease, musculoskeletal disease within a year in case of a history of the hospital, if there is that of a fall in one year prior to the study entry point. Severely requiring restriction of movement, if you have a disease that requires medication.
Target sample size	20

Research contact person
Name of lead principal investigator	Kimura Akira
Organization	Graduate School of Health Sciences, Gunma PAZ College,Japan
Division name	Department of Health Sciences
Address	Tonyamachi 1-7-1 Takasaki Gunma Japan
TEL	81-27-388-0865
Email	kimuaki@nifty.com

Public contact
Name of contact person	Kimura Akira
Organization	Graduate School of Health Sciences, Gunma PAZ College,Japan
Division name	Department of Health Sciences
Address	Tonyamachi 1-7-1 Takasaki Gunma Japan
TEL	81-27-388-0865
Homepage URL	http://kimuakilabo.main.jp/Research/
Email	kimuaki@nifty.com

Sponsor
Institute	Gunma PAZ College
Institute
Department

Funding Source
Organization	Gunma PAZ College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	草津町福祉センター（群馬県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 03 Day
Anticipated trial start date	2015 Year 08 Month 26 Day
Last follow-up date	2016 Year 03 Month 24 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 04 Month 15 Day
Date analysis concluded	2016 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/jpts/28/10/28_jpts-2016-489/_article
Results
Other related information

Management information
Registered date	2015 Year 08 Month 20 Day
Last modified on	2017 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021681