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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032980
Receipt No. 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 2018/06/13

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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 Cluster
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

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
Last name of lead principal investigator
1st name
Middle name
Last name Tomohiro Okura
Organization University of Tsukuba
Division name Faculty of Health and sport science
Zip code
Address 1-1-1, Tennodai
TEL 0298591593
Email yoon.jieun.fu@u.tsukuba.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Jieun Yoon
Organization Univeristy of Tsukuba
Division name Faculty of Health and sport science
Zip code
Address Tennodai
TEL 0298591593
Homepage URL
Email yoon.jieun.fu@u.tsukuba.ac.jp

Sponsor
Institute Univertity of Tsukuba
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
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
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037604

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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