UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025665 |
|---|---|
| Receipt number | R000029524 |
| Scientific Title | Microgravity inspection study by the plane experiment using the hybrid training system device attached to the sitting position type bicycle ergometer |
| Date of disclosure of the study information | 2017/01/16 |
| Last modified on | 2018/07/17 05:34:27 |
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Basic information
Public title
Microgravity inspection study by the plane experiment using the hybrid training system device attached to the sitting position type bicycle ergometer
Acronym
Microgravity inspection study using the hybrid training system device attached to the sitting position type bicycle ergometer
Scientific Title
Microgravity inspection study by the plane experiment using the hybrid training system device attached to the sitting position type bicycle ergometer
Scientific Title:Acronym
Microgravity inspection study using the hybrid training system device attached to the sitting position type bicycle ergometer
Region
| Japan |
Condition
Condition
disuse syndrome
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A locus type bicycle ergometer attached to the hybrid training system tests whether even (microgravity bottom) is available in a track.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
electrical potential, crank angle, oxygen uptake, arterial oxygen saturation, heart rate
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Subjects drive sitting position type ergometer while doing the hybrid training of lower limbs for three minutes.
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
| 25 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
The subject who does not have disease in a circulatory system and a locomotor system in 20-30 years old.
Key exclusion criteria
The subject with the disease in a circulatory system and a locomotor system.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Shiba |
Organization
Kurume university
Division name
Orthopedics
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka 830-0011
TEL
0942-31-7568
nshiba@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Omoto |
Organization
Kurume university
Division name
Orthopedics
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka 830-0011
TEL
0942-31-7568
Homepage URL
omoto_masayuki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
県営名古屋空港 Nagoya Airport
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 16 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 13 | Day |
Last modified on
| 2018 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029524
