UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multidirectional inspection of 1RM in the knee extension and the isometric peak torque estimate
Title of the study (Brief title)	Multidirectional inspection of 1RM in the knee extension and the isometric peak torque estimate
Region	Japan

Condition
Condition	Healthy subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A purpose of this study is to establish a method reliability and validity are high and to estimate 1RM for simpleness and easiness using relations of the force - velocity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1 Repetition maximum
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Inspection 1: Body composition ingredient measurement. Inspection 2: The isometric knee extension peak torque measurement by Hand-Held Dynamometer. Inspection 3: 1RM measurement before and after the improvement of the leg extension machine. Measurement of the isometric knee extension peak torque by Biodex.
Interventions/Control_2
Interventions/Control_3
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	40 years-old >=
Gender	Male
Key inclusion criteria	Has a normal (including corrected visual acuity) vision and hearing, nervous system disease, orthopedic disease, disorder with no healthy adults in cardiopulmonary function.
Key exclusion criteria	1. The one that is subject to exercise restrictions from family medicine. 2. The exercise whom explanation is hard to understand. 3. Sharp pain having outbreak canceling exercise. 4. The one that has an ongoing progressive disease, acute disease and an unstable chronic disease rapidly. 5. The high blood pressure, tachycardia which has the past.
Target sample size	100

Research contact person
Name of lead principal investigator	tamura ryosuke
Organization	Health Care Service Facility for The Aged Shimahouwaen
Division name	Department of Rehabilitation
Address	Shima, Mie Prefecture,Agochou,Koh 1061-152
TEL	0599-46-1122
Email	tamura@houwakai.or.jp

Public contact
Name of contact person	etsuko namikawa
Organization	Fujita Health University
Division name	Medical study ERB secretariat
Address	Toyoake,Aichi Prefecture,Kutsukakechou,Dengakugakubo 1-98
TEL	0562-93-2139
Homepage URL
Email	f-irb@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Other
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	2016 Year 04 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 02 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 04 Month 27 Day
Last modified on	2017 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025436