UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018738 |
|---|---|
| Receipt number | R000021681 |
| Scientific Title | Factors that encourage physical activity associated with health-related indicators in the visually impaired elderly |
| Date of disclosure of the study information | 2015/08/20 |
| Last modified on | 2017/06/23 00:43:07 |
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Basic information
Public title
Factors that encourage physical activity associated with health-related indicators in the visually impaired elderly
Acronym
Health promotion blind challenge study
Scientific Title
Factors that encourage physical activity associated with health-related indicators in the visually impaired elderly
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kimura Akira |
Organization
Graduate School of Health Sciences, Gunma PAZ College,Japan
Division name
Department of Health Sciences
Zip code
Address
Tonyamachi 1-7-1 Takasaki Gunma Japan
TEL
81-27-388-0865
kimuaki@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimura Akira |
Organization
Graduate School of Health Sciences, Gunma PAZ College,Japan
Division name
Department of Health Sciences
Zip code
Address
Tonyamachi 1-7-1 Takasaki Gunma Japan
TEL
81-27-388-0865
Homepage URL
http://kimuakilabo.main.jp/Research/
kimuaki@nifty.com
Sponsor or person
Institute
Gunma PAZ College
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jpts/28/10/28_jpts-2016-489/_article
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 03 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021681
