UMIN-CTR Clinical Trial

Basic information
Public title	A biomechanical analysis of hammerobics exercise
Acronym	A biomechanical analysis of hammerobics exercise
Scientific Title	A biomechanical analysis of hammerobics exercise
Scientific Title:Acronym	A biomechanical analysis of hammerobics exercise
Region	Japan

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

Objectives
Narrative objectives1	We will use surface EMG, 3D motion capture system and force plate to analyze subjects' motion while they are doing hammerobics exercise. Hammerobics exercise is the exercise that Koji Murofushi, the Japanese olympic gold medalist hammer thrower used to train with. The purpose of this study is to find characteristics of this exercise and test its effectiveness for athletes' injury prevention and performance enhancement.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The test is done using 3 different motions using different hammer conditions. Essentially, subjects are required to squat down so that the both right and left femurs are parallel to the floor, and when the position is achieved, we count the test as a fail. Each subject has to have 3 successful tests. We will use surface EMG, force plate and 3D motion capture analysis system: 1. Motion condition: 10 seconds isometric squat, 10 second "Hammer Sync", 10 seconds "Hammer Alternate". 2. Training condition: "Hammerobics" (7.26kg hammer, 50cm wire), "Rigid Body" (1m pipe x 2.5kg barbell plate x2) 3. Barbell condition: the sum of the weight of hammer and barbell (20kg) is always 55kg. Same is applied to both rigid body and isometric squat.
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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	1. Motion condition: 10 seconds isometric squat, 10 second "Hammer Sync", 10 seconds "Hammer Alternate". 2. Training condition: "Hammerobics" (7.26kg hammer, 50cm wire), "Rigid Body" (1m pipe x 2.5kg barbell plate x2) 3. Barbell condition: the sum of the weight of hammer and barbell (20kg) is always 55kg. Same is applied to both rigid body and isometric squat.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who: - are healthy and have no problems with daily activities - are aged over 18 and under 80 when signing the participation consent form or when attending the exam.
Key exclusion criteria	Those who: - have pain - have problems with daily activities - are prohibited from exercising by a doctor - have history of injuries which prevented the person from exercising over a month
Target sample size	50

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, Japan
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	2018 Year 09 Month 20 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	Enrolling by invitation
Date of protocol fixation	2018 Year 07 Month 20 Day
Date of IRB	2020 Year 08 Month 13 Day
Anticipated trial start date	2018 Year 07 Month 20 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 18 Day
Last modified on	2020 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038928