UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024716
Receipt number 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 08:21:37

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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 or person

Institute

Nagoya University
Research Center of Health Physical Fitness and Sports

Institute

Department

Personal name



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

Value
https://center6.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