UMIN-CTR Clinical Trial

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
Email	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
Email	yoon.jieun.fu@u.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038842