UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039004
Receipt number R000044461
Scientific Title Verifying the immediate effect of core activation and timing from the novel isometric method.
Date of disclosure of the study information 2020/03/01
Last modified on 2019/12/26 14:34:19

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Basic information

Public title

Verifying the immediate effect of core activation and timing from the novel isometric method.

Acronym

Verifying the immediate effect of core activation and timing from the novel isometric method.

Scientific Title

Verifying the immediate effect of core activation and timing from the novel isometric method.

Scientific Title:Acronym

Verifying the immediate effect of core activation and timing from the novel isometric method.

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verifying the immediate effect of core activation and timing from the novel isometric method which has the potential to improve performance and rehabilitation. This method is proposed by Professor Koji Murofushi Tokyo Medical and Dental University.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Assess efficacy of novel designed isometric method by
comparing with existing isometric method, verifying immediate effect by pre and post-exercise intervention.

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Trunk activation and timing are key to improve performance, injury prevention, and rehabilitation. Verifying the novel isometrics method by comparing the existing isometrics method by measuring the movement and muscle activation patterns can find an effective way improve trunk stability muscle activation sequencing for sports performance and rehabilitation.

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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who:
- are healthy and have no problems with daily activities
-are aged 18 and under 80 when singing the participation consent form or when attending the exam.

Key exclusion criteria

Those who:
-have pain
-have probelms with daily activities
-are prohibited from exercising by doctor
-have history of injuries which prevented the person from exercising over a month

Target sample size

32


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Murofushi

Organization

Tokyo Medical and Dental University

Division name

Sports Science Center

Zip code

1138510

Address

1-5-45 Yushima Bunkyo-ku Tokyo

TEL

03-5803-4364

Email

kmurssc@tmd.ac.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Yamaguchi

Organization

Tokyo Medical and Dental University

Division name

Sports Science Center

Zip code

1138510

Address

1-5-45 Yushima Bunkyo-ku Tokyo

TEL

03-5803-4364

Homepage URL


Email

diceyamaguchi.ssc@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Bioethics Research Center, Tokyo Medical and Dental University

Address

1-5-45 Yushima Bunkyo-ku Tokyo

Tel

03-5803-4724

Email

info.bec@tmd.ac.jp


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

2020 Year 03 Month 01 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

Preinitiation

Date of protocol fixation

2020 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2023 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 12 Month 26 Day

Last modified on

2019 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name