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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025665
Receipt No. 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

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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
Email 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
Email omoto_masayuki@med.kurume-u.ac.jp

Sponsor
Institute Kurume university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029524

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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