UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032980 |
|---|---|
| Receipt number | R000037604 |
| Scientific Title | Effect of square stepping exercise on cognitive function and physical function |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2023/07/17 15:35:04 |
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Basic information
Public title
Effect of square stepping exercise on cognitive function and physical function
Acronym
Effect of square stepping exercise
Scientific Title
Effect of square stepping exercise on cognitive function and physical function
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
Amyloid beta
Key secondary outcomes
Brain-derived neutrophic factor, Five cog, Trail making peg test, 5 m habitual walk test, three-times-sit to stand movement test, timed up and go, 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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Square stepping exercise for 48 weeks
Interventions/Control_2
Walking for 48 weeks
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
(1) Participants is fully informed about the study and has signed the information consent form
(2) Participant who gets motivated to this study
(3) Age of 65 years of older
(4) Not have engaged in organized regular physical exercise and sport
Key exclusion criteria
(1) In the acute phase of a disease
(2) Unable to walk without support
(3) Unable to attend the study briefing or continuously attend the training
Target sample size
60
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
1-1-1, Tennodai
TEL
0298591593
yoon.jieun.fu@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Jieun |
| Middle name | |
| Last name | Yoon |
Organization
Univeristy of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8550
Address
Tennodai
TEL
0298591593
Homepage URL
yoon.jieun.fu@u.tsukuba.ac.jp
Sponsor or person
Institute
Univertity of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
University of Tsukuba
Address
1-1-1, TENODAI, TSUKUBA
Tel
+81-029-853-2571
hitorinri@un.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（茨城県，つくば市）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 01 | 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 | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037604
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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