UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040861 |
|---|---|
| Receipt number | R000046650 |
| Scientific Title | Verify the effects of Hammerobics exercise |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2020/06/23 09:28:07 |
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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
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
diceyamaguchi.tmdu.ssc@gmail.com
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, Japan
Tel
03-5803-4724
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046650
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