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

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 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

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
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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2023/04/19 PeerJ-8290.pdf