UMIN-CTR Clinical Trial

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
Institute	Tokyo Medical and Dental University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044461