UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038995 |
|---|---|
| Receipt number | R000044468 |
| Scientific Title | An experiment to verify the effectiveness of pneumatic whole-body exercise training device |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2019/12/25 16:27:50 |
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Basic information
Public title
An experiment to verify the effectiveness of pneumatic whole-body exercise training device
Acronym
An experiment to verify the effectiveness of pneumatic whole-body exercise training device
Scientific Title
An experiment to verify the effectiveness of pneumatic whole-body exercise training device
Scientific Title:Acronym
An experiment to verify the effectiveness of pneumatic whole-body exercise training device
Region
| Japan |
Condition
Condition
training of the muscular system and nervous system
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A proposition of a novel training device to enhance the muscular system and nervous system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The trajectory of the center of pressure in footprint, electromyogram of the leg, and trainee's posture are measured in the evaluation experiment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
One leg squat posture without load (20s 3sets)
Interventions/Control_2
One leg squat posture with cyclic load (20s 3sets)
Interventions/Control_3
One leg squat posture with random load (20s 3sets)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male more than 20 years old
Key exclusion criteria
Excludes persons without exercise habits and persons with disabilities who have a history of trauma that has impaired standing or walking ability, or who have undergone surgery on the trunk or lower limbs.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Miyazaki |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
101-0062
Address
2-3-10 Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
09034368175
tmiyazaki.bmc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Miyazaki |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
101-0062
Address
2-3-10 Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
09034368175
Homepage URL
tmiyazaki.bmc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Bridgestone corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
2-3-10 Kanda Surugadai, Chiyoda-ku, Tokyo
Tel
0352808163
tmiyazaki.bmc@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 | 01 | 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
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 12 | Month | 25 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044468
