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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031456
Receipt No. R000035911
Scientific Title A comprehensive study of physiological anthropology for human bipedal locomotion
Date of disclosure of the study information 2021/03/31
Last modified on 2019/11/25

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Basic information
Public title A comprehensive study of physiological anthropology for human bipedal locomotion
Acronym Physiological anthropology for human locomotion
Scientific Title A comprehensive study of physiological anthropology for human bipedal locomotion
Scientific Title:Acronym Physiological anthropology for human locomotion
Region
Japan North America

Condition
Condition Healthy populations
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of different inspired oxygen fraction (hypoxia or hyperoxia), reduced gravity, added mass, gradients (uphill/level/downhill), alterations of treadmill speed on the ES, EOTS, and CoT.
Basic objectives2 Others
Basic objectives -Others To examine muscle activity and motor unit recruitment patterns of the lower leg extremities under several conditions described above.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Economical Speed, Energetically optimal transition speed, and Cost of Transport
Key secondary outcomes Electromyography

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 6
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Moderate hypoxia (13-17% FiO2) and hyperoxia (40% FiO2)
Interventions/Control_2 Gradient (0%-Level and +5%-Uphill)
Interventions/Control_3 Treadmill speed
Interventions/Control_4 aging
Interventions/Control_5 obesity, BMI
Interventions/Control_6 body weight support
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria In accordance with the Declaration of Helsinki, all participants were provided all information about the purpose and experimental protocols, a written informed consent was obtained from all participants. An ethical committee established in Kyushu Sangyo University approved all procedures of this study (H28-0001).
Key exclusion criteria Without any candidates taking classes of testers' classes.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Daijiro
Middle name
Last name Abe
Organization Kyushu Sangyo University
Division name Center for Health and Sports Science
Zip code 813-0003
Address 2-3-1 Matsukadai, Higashi-ku, Fukuoka-shi
TEL +81-92-673-5887
Email abed@ip.kyusan-u.ac.jp

Public contact
Name of contact person
1st name Daijiro
Middle name
Last name Abe
Organization Kyushu Sangyo University
Division name Center for Health and Sports Science
Zip code 813-0003
Address 2-3-1 Matsukadai, Higashi-ku, Fukuoka-shi
TEL +81-92-673-5887
Homepage URL
Email abed@ip.kyusan-u.ac.jp

Sponsor
Institute Center for Health and Sports Science,
Kyushu Sangyo University
Institute
Department

Funding Source
Organization 1) Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science

2) Kyushu Sangyo University
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 Center for Health and Sports Science, Kyushu Sangyo University
Address 2-3-1 Matsukadai, Higashi-ku, Fukuoka-shi
Tel +81-92-673-5887
Email abed@ip.kyusan-u.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 九州産業大学健康スポーツ科学センター

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 20
Results 1. doi: 10.1186/s40101-018-0177-7
2. doi: 10.1186/s40101-019-0208-z
3.
Results date posted
2019 Year 03 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 06 Month 19 Day
Baseline Characteristics healthy young and elderly people
Participant flow Normoxia, Hyperopia
Adverse events None
Outcome measures CoT, phase shift
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
2017 Year 05 Month 12 Day
Anticipated trial start date
2018 Year 05 Month 20 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 23 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035911

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/12/18 PeerJ-8290.pdf


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