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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017690
Receipt No. R000020501
Scientific Title Physiological anthropological for human bipedal locomotion
Date of disclosure of the study information 2018/03/31
Last modified on 2019/03/25

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Basic information
Public title Physiological anthropological for human bipedal locomotion
Acronym Physiological anthropology for human locomotion
Scientific Title Physiological anthropological for human bipedal locomotion
Scientific Title:Acronym Physiological anthropology for human locomotion
Region
Japan

Condition
Condition healthy people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is planning to investigate the cross-effects of inspired oxygen concentrations and gradient slope on economical walking speed and transition speed.
Basic objectives2 Others
Basic objectives -Others Experimental investigation for biological implications of economical walking speed and transition speed in healthy humans
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Cost of Transport (CoT; mL/kg/km)
Key secondary outcomes EMG (uV/step) and MPF (Hz)

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 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Inspired oxygen concentration
Interventions/Control_2 gradient (level, uphill, and downhill)
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

Not applicable
Gender Male
Key inclusion criteria No cardiovascular diseases and/or no current injuries for locomotive abilities.
Key exclusion criteria Cases other than above.
Target sample size 15

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 813-8503
Address 2-3-1 Matsukadai, Higashi-ku, Fukuoka 813-8503, Japan
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 813-8503
Address 2-3-1 Matsukadai, Higashi-ku, Fukuoka 813-8503, Japan
TEL +81-92-673-5887
Homepage URL
Email abed@ip.kyusan-u.ac.jp

Sponsor
Institute Kyushu Sangyo University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan
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 Kyushu Sangyo University
Address 2-3-1 Matsukadai, Higashi-ku, Fukuoka City, Fukuoka 813-8503, Japan
Tel +81926735887
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(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 31 Day

Related information
URL releasing protocol http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0138154
Publication of results Published

Result
URL related to results and publications http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0173816
Number of participants that the trial has enrolled 15
Results
Major findings can be found at following link:
1) doi: 10.1371/journal.pone.0173816.
2) doi: 10.1242/bio.019810.
3) doi: 10.1038/s41598-017-05068-8.
Results date posted
2019 Year 03 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2017 Year 03 Month 16 Day
Baseline Characteristics
Healthy young males
Participant flow
Normoxia, Hypoxia
Adverse events
None
Outcome measures
CoT
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 10 Day
Last follow-up date
2016 Year 04 Month 20 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information Exercise protocol has been determined based on our previous study (ref.1). This was determined until early 2015. With respect to the inspired oxygen fraction was referenced from our another recent study (ref.2).

1. Daijiro Abe, Yoshiyuki Fukuoka, Masahiro Horiuchi. Economical speed and energetically optimal transition speed evaluated by gross and net oxygen cost of transport at different gradients. PLoS ONE 10(9): e0138154.
2. Masahiro Horiuchi, Yoko Handa, Daijiro Abe, Yoshiyuki Fukuoka. Walking economy at simulated high altitude in human healthy young male lowlanders. Biology Open 5: 1408-1414, 2016.
(doi: 10.1242/bio.019810)

Management information
Registered date
2015 Year 05 Month 26 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020501

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/03/25 Sci Rep.pdf


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