UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022112
Receipt number R000025436
Scientific Title Multidirectional inspection of 1RM in the knee extension and the isometric peak torque estimate
Date of disclosure of the study information 2016/04/27
Last modified on 2017/10/03 17:34:36

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Basic information

Public title

Multidirectional inspection of 1RM in the knee extension and the isometric peak torque estimate

Acronym

Multidirectional inspection of 1RM in the knee extension and the isometric peak torque estimate

Scientific Title

Multidirectional inspection of 1RM in the knee extension and the isometric peak torque estimate

Scientific Title:Acronym

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

1st name
Middle name
Last name tamura ryosuke

Organization

Health Care Service Facility for The Aged Shimahouwaen

Division name

Department of Rehabilitation

Zip code


Address

Shima, Mie Prefecture,Agochou,Koh 1061-152

TEL

0599-46-1122

Email

tamura@houwakai.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name etsuko namikawa

Organization

Fujita Health University

Division name

Medical study ERB secretariat

Zip code


Address

Toyoake,Aichi Prefecture,Kutsukakechou,Dengakugakubo 1-98

TEL

0562-93-2139

Homepage URL


Email

f-irb@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 27 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 04 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025436


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name