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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042413
Receipt No. R000048381
Scientific Title The effect of REIHO training on knee extension force
Date of disclosure of the study information 2020/12/01
Last modified on 2021/02/09

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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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