UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031456 |
|---|---|
| Receipt number | 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 | 2024/02/28 17:03:38 |
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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, Cost of Transport, Planar covariation law
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
7
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, Sinusoidal speed change
Interventions/Control_4
aging
Interventions/Control_5
obesity, BMI
Interventions/Control_6
body weight support
Interventions/Control_7
visual illusion
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
60
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
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
abed@ip.kyusan-u.ac.jp
Sponsor or person
Institute
Center for Health and Sports Science,
Kyushu Sangyo University
Institute
Department
Personal name
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
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
100
Results
1. doi: 10.1186/s40101-018-0177-7
2. doi: 10.1186/s40101-019-0208-z
3. doi: 10.7717/peerj.8290
4. doi: 10.1186/s13102-021-00336-7
5. doi: 10.1186/s40101-022-00298-w
6. doi: 10.1016/j.gaitpost.2023.08.029
7. doi: 10.1186/s13104-023-06545-2
Results date posted
| 2019 | Year | 03 | Month | 25 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Further research progress is expected to be conducted.
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, body-weight-support, gait stability
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
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 23 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.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 |
| 2023/04/19 | JPA-2022.pdf |
