UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the validity to the fatigue after an endurance performance for athlete by physiotherapy
Title of the study (Brief title)	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	Takamasa Mizuno
Organization	Nagoya University
Division name	Research Center of Health Physical Fitness and Sports
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	Takamasa Mizuno
Organization	Nagoya University
Division name	Research Center of Health Physical Fitness and Sports
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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