UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of eccentric cycle exercise training in healthy people
Title of the study (Brief title)	Effect of eccentric cycle exercise training in healthy people
Region	Japan

Condition
Condition	heart disease pulmonary disease
Classification by specialty	Cardiology Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of eccentric cycle exercise training in healthy people
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	isometric muscle strength of lower extremity
Key secondary outcomes	muscle thickness of quadriceps exercise tolerance

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	eccentric cycle training
Interventions/Control_2	concentric cycle training
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	35 years-old >
Gender	Male and Female
Key inclusion criteria	healthy people
Key exclusion criteria	He or she is not prohibited any exercise by their doctor in charge. He or she doesn't have any risks or disease which obstruct to take exercise, such as internal or orthopedic disease.
Target sample size	30

Research contact person
Name of lead principal investigator	Akira Tamaki
Organization	Graduate school of medicine Kyoto university
Division name	Department of motor function and development
Address	53, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person
Organization	Graduate school of medicine Kyoto university
Division name	Department of motor function and development
Address	sho-ch@manw0w0.mbox.media.kyoto-u.ac.jp
TEL
Homepage URL
Email

Sponsor
Institute	Graduate school of medicine Kyoto university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding 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

Other administrative information
Date of disclosure of the study information	2009 Year 06 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 24 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2009 Year 10 Month 01 Day
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	2009 Year 06 Month 24 Day
Last modified on	2016 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002580