UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053827
Receipt number R000061435
Scientific Title Comparison of characteristics in running outdoors and treadmill running, differences based on assessment of physiological and subjective measures
Date of disclosure of the study information 2024/03/12
Last modified on 2024/03/11 14:29:42

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Basic information

Public title

Comparison of characteristics in running outdoors and treadmill running, differences based on assessment of physiological and subjective measures

Acronym

Comparison of characteristics in running outdoors and treadmill running, differences based on assessment of physiological and subjective measures

Scientific Title

Comparison of characteristics in running outdoors and treadmill running, differences based on assessment of physiological and subjective measures

Scientific Title:Acronym

Comparison of characteristics in running outdoors and treadmill running, differences based on assessment of physiological and subjective measures

Region

Japan


Condition

Condition

healthy young people

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the usefulness of running on a treadmill and outdoors by comparing the characteristics of running on a treadmill with healthy young participants with exercise habits.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

modified Borg scale, 12-minute field performance test

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

12-minute field performance test in outdoor running, 12-minute field performance test in treadmill running

Interventions/Control_2


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

30 years-old >=

Gender

Male

Key inclusion criteria

At least twice a week and 30 minutes per session and have been exercising for more than one year.

Key exclusion criteria

History of psychiatric, neurological, and musculoskeletal disorders
Previous history that may affect the movement in the measurement.
Physical pain during running movements.

Target sample size

17


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Shimamura

Organization

Kumamoto Health Science University

Division name

Faculty of Health Science, Department of Rehabilitation

Zip code

861-5598

Address

325 Izumi-machi, Kita-ku, Kumamoto, Japan

TEL

096-275-2162

Email

shimamura@kumamoto-hsu.ac.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Shimamura

Organization

Kumamoto Health Science University

Division name

Faculty of Health Science, Department of Rehabilitation

Zip code

861-5598

Address

325 Izumi-machi, Kita-ku, Kumamoto, Japan

TEL

096-275-2162

Homepage URL


Email

shimamura@kumamoto-hsu.ac.jp


Sponsor or person

Institute

Kumamoto Health Science University

Institute

Department

Personal name



Funding Source

Organization

Kumamoto Health Science University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kumamoto Health Science University

Address

325 Izumi-machi, Kita-ku, Kumamoto, Japan

Tel

096-275-2112

Email

kikaku@kumamoto-hsu.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



Other administrative information

Date of disclosure of the study information

2024 Year 03 Month 12 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2024 Year 03 Month 11 Day

Date of IRB

2024 Year 03 Month 11 Day

Anticipated trial start date

2024 Year 03 Month 12 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 03 Month 11 Day

Last modified on

2024 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061435


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name