UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044406 |
|---|---|
| Receipt number | 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 | 2022/12/03 12:20:38 |
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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
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
pseudolefty811@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
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
| 2022 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
