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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024716
Receipt No. R000028434
Scientific Title A study on the validity to the fatigue after an endurance performance for athlete by physiotherapy
Date of disclosure of the study information 2016/11/04
Last modified on 2017/11/07

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Basic information
Public title A study on the validity to the fatigue after an endurance performance for athlete by physiotherapy
Acronym Efficacy test of physiological therapy for fatigue after an endurance performance
Scientific Title A study on the validity to the fatigue after an endurance performance for athlete by physiotherapy
Scientific Title:Acronym Efficacy test of physiological therapy for fatigue after an endurance performance
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the validity to the fatigue after an endurance performance by physiotherapy for athlete
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the blood lactate concentration, oxidative stress, muscular power, electromyogram, kinetic property of a muscle and clinical validation of fatigue feeling in the vicinity physical therapy treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Make to exercise -> Apply the physical therapy 1 for 15minutis once a day -> rest for 1week -> Make to exercise -> Apply the physical therapy 2 for 15minutis once a day -> rest for 1week -> Apply the physical therapy 3 for 15minutis once a day
Interventions/Control_2 Make to exercise -> Apply the physical therapy 1 for 15minutis once a day -> rest for 1week -> Make to exercise -> Apply the physical therapy 3 for 15minutis once a day -> rest for 1week -> Apply the physical therapy 2 for 15minutis once a day
Interventions/Control_3 Make to exercise -> Apply the physical therapy 2 for 15minutis once a day -> rest for 1week -> Make to exercise -> Apply the physical therapy 1 for 15minutis once a day -> rest for 1week -> Apply the physical therapy 3 for 15minutis once a day
Interventions/Control_4 Make to exercise -> Apply the physical therapy 2 for 15minutis once a day -> rest for 1week -> Make to exercise -> Apply the physical therapy 3 for 15minutis once a day -> rest for 1week -> Apply the physical therapy 1 for 15minutis once a day
Interventions/Control_5 Make to exercise -> Apply the physical therapy 3 for 15minutis once a day -> rest for 1week -> Make to exercise -> Apply the physical therapy 1 for 15minutis once a day -> rest for 1week -> Apply the physical therapy 2 for 15minutis once a day
Interventions/Control_6 Make to exercise -> Apply the physical therapy 3 for 15minutis once a day -> rest for 1week -> Make to exercise -> Apply the physical therapy 2 for 15minutis once a day -> rest for 1week -> Apply the physical therapy 1 for 15minutis once a day
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
60 years-old >
Gender Male
Key inclusion criteria Healthy males
Key exclusion criteria -Subjects with atopic dermatitis, eczema and pollen allergy.
-Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takamasa Mizuno
Organization Nagoya University
Division name Research Center of Health Physical Fitness and Sports
Zip code
Address Furo-cho, Chikusa-ku, Nagoya 464-8601, Japan
TEL 052-789-3959
Email mizuno@htc.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamasa Mizuno
Organization Nagoya University
Division name Research Center of Health Physical Fitness and Sports
Zip code
Address Furo-cho, Chikusa-ku, Nagoya 464-8601, Japan
TEL 052-789-3959
Homepage URL
Email mizuno@htc.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Research Center of Health Physical Fitness and Sports
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋大学総合保健体育科学センター・体育科学部(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 04 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
2016 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 04 Day
Last modified on
2017 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028434

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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