UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017690 |
|---|---|
| Receipt number | R000020501 |
| Scientific Title | Physiological anthropological for human bipedal locomotion |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2023/04/19 21:29:20 |
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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
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
abed@ip.kyusan-u.ac.jp
Sponsor or person
Institute
Kyushu Sangyo University
Institute
Department
Personal name
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
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
4) doi: 10.1186/s40101-018-0177-7
5) doi: 10.1186/s40101-019-0211-4
6) doi: 10.7717/peerj.8290
7) doi: 10.1186/s13102-021-00336-7
8) doi: 10.1186/s40101-022-00298-w
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 and elderly adults
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
| 2015 | Year | 07 | Month | 17 | Day |
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
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020501
