UMIN-CTR Clinical Trial

Basic information
Public title	Verify the effects of Hammerobics exercise
Acronym	Verify the effects of Hammerobics exercise
Scientific Title	Verify the effects of Hammerobics exercise
Scientific Title:Acronym	Verify the effects of Hammerobics exercise
Region	Japan

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

Objectives
Narrative objectives1	Hammerobics exercise is the concept of parametric oscillation, responding to an ever-changing stimulus with rhythm and timing.This study validating from intervention, whether the nature of the movement of oscillation will enhance postural, core stability and foot intrinsic muscle. Different types of swinging motion(synchronized, alternative, side-ways) will provide stimulus to various parts of the muscle that potentially can avoid repetitive and same motion from daily movement patterns.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The test will be occur using 3 different motions using different hammer conditions. Essentially, subjects are required to squat down so that 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 will test has to have 3 successful tests.Two month of intervention is going to be execute and compare before after. We will use surface EMG, force plate, 3D motion capture analysis system, ultrasound to measure foot muscle: 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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Those who: - are healthy and have no problems with daily activities - are aged over 18 and under 50 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	24

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.tmdu.ssc@gmail.com

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	2020 Year 10 Month 15 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	2020 Year 07 Month 15 Day
Date of IRB	2020 Year 07 Month 07 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2020 Year 08 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 06 Month 22 Day
Last modified on	2020 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046650