UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038708 |
|---|---|
| Receipt number | R000038842 |
| Scientific Title | Effect of Square Stepping Exercise on cognitive function and physical function -Randomized controlled trial |
| Date of disclosure of the study information | 2019/11/28 |
| Last modified on | 2019/11/28 16:45:52 |
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Basic information
Public title
Effect of Square Stepping Exercise on cognitive function and physical function -Randomized controlled trial
Acronym
Effect of Square Stepping Exercise
Scientific Title
Effect of Square Stepping Exercise on cognitive function and physical function -Randomized controlled trial
Scientific Title:Acronym
Effect of Square Stepping Exercise
Region
| Japan | Asia(except Japan) |
Condition
Condition
A healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of square stepping exercise on cognitive function and physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amyoiud beta
Key secondary outcomes
Brain-derived neutrophic factor, five-cog, Train making peg test, 5 m habitual walk test, Three-times-sit to stand movement test, Timed up and go test, Hand grip strength, One leg balance test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Square stepping exercise group
Interventions/Control_2
walking group
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Female
Key inclusion criteria
NOT ROUTINELY EXERCISE
Key exclusion criteria
NOT ROUTINELY EXERCISE
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | OKURA |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8550
Address
1-2, KASUGA
TEL
0298591593
yoon.jieun.fu@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Jieun |
| Middle name | |
| Last name | YOON |
Organization
Uiversity of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8550
Address
1-2, KASUGA
TEL
0298591593
Homepage URL
yoon.jieun.fu@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Uiversity of Tsukuba
Address
1-2, KASUGA, TSUKUBA
Tel
0298591593
yoon.jieun.fu@u.tsukuba.ac.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
筑波大学 高細精医療イノベーション棟
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 28 | 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
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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 28 | Day |
Last modified on
| 2019 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038842
