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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044406
Receipt No. R000050687
Scientific Title Verification of Performance Improvement and Fatigue Reduction Effect by flossing for Athletes
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/02

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Basic information
Public title Verification of Performance Improvement and Fatigue Reduction Effect by flossing for Athletes
Acronym Verification of Performance Improvement and Fatigue Reduction Effect by flossing for Athletes
Scientific Title Verification of Performance Improvement and Fatigue Reduction Effect by flossing for Athletes
Scientific Title:Acronym Verification of Performance Improvement and Fatigue Reduction Effect by flossing for Athletes
Region
Japan

Condition
Condition locomotor disorders
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to assess whether the fatigue reduction effect of flossing during competition will improve performance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Record of pitching, short splint, and running.
Key secondary outcomes Muscle power

Base
Study type Interventional

Study design
Basic design Cross-over
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 Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Flossing
Interventions/Control_2 stretching
Interventions/Control_3 No treaatment
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
50 years-old >=
Gender Male
Key inclusion criteria 1) Athletes who regularly carry out pitching or 20m sprints, which is the evaluation event this time.
2) Athletes who have reached the adult age at the time of obtaining consent.
3) Athletes who received sufficient explanation before participating in this study, and after sufficient understanding, obtained the voluntary written consent of all the subjects.
Key exclusion criteria 1) All subjects with pain who need to take anti-inflammatory analgesics during evaluation exercise
2) All subjects who have a history of allergies to the materials of the test equipment
3) In addition, all the subjects who the principal investigator judged to be inappropriate as all the subjects
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Kenmoku
Organization Kitasato University School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 2520-374
Address Kitazato 1-15-1 Minami-ku, Sagamihara city, Kanagawa
TEL 042-778-8111
Email pseudolefty811@yahoo.co.jp

Public contact
Name of contact person
1st name Tomonori
Middle name
Last name Kenmoku
Organization Kitasato University School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 252-0374
Address Kitazato 1-15-1 Minami-ku, Sagamihara city, Kanagawa
TEL 042-778-8111
Homepage URL
Email pseudolefty811@yahoo.co.jp

Sponsor
Institute Department of Orthopaedic Surgery, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Sanct Japan Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kitasato University Department of Allied Health Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitasato University Medical Ethics Organization for Clinical Research
Address Kitazato 1-15-1 Minami-ku, Sagamihara city, Kanagawa
Tel 042-778-8111
Email rinrib@med.kitasato-u.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
2021 Year 07 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
2021 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 02 Day
Last modified on
2021 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050687

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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