UMIN-CTR Clinical Trial

Basic information
Public title	The effect of REIHO training on knee extension force
Acronym	REIHO and knee extension force
Scientific Title	The effect of REIHO training on knee extension force
Scientific Title:Acronym	REIHO and knee extension force
Region	Japan

Condition
Condition	healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Reiho of Ogasawara style is a traditional lifestyle of Samurai warriors. Reiho way of standing and sitting requires squatting. This study aims to investigate if the Ogasawara Reiho lifestyle is effective in muscle strengthening.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Isometric knee extension force 3months after the start of training
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	REIHO standing up from the floor, sitting on the floor, and half sitting on the floor following the pre-recorded instruction movie for 5 minutes. 4 times per week for 3 months.
Interventions/Control_2	Control group without REIHO training.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	No previous REIHO experience
Key exclusion criteria	Having disease or disability that impairs activities of daily living.
Target sample size	58

Research contact person
Name of lead principal investigator	1st name Ryoichi Middle name Last name Nagatomi
Organization	Tohoku University
Division name	Graduate School of Biomedical Engineering
Zip code	980-8575
Address	Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL	022-717-8586
Email	nagatomi@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Ryoichi Middle name Last name Nagatomi
Organization	Tohoku University
Division name	Graduate School of Biomedical Engineering
Zip code	980-8575
Address	Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL	022-717-8586
Homepage URL
Email	nagatomi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Biomedical Engineering
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Graduate School of Medicine
Address	Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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

Other administrative information
Date of disclosure of the study information	2020 Year 12 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	Enrolling by invitation
Date of protocol fixation	2020 Year 11 Month 05 Day
Date of IRB	2020 Year 12 Month 14 Day
Anticipated trial start date	2020 Year 12 Month 22 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 11 Day
Last modified on	2021 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048381

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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