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 | 2025/04/02 17:13:28 |
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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
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
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
The heart rate after outdoor and treadmill running was 132.7_12.5 bpm outdoor and 123.8_9.0 bpm treadmill, and the mean modified Borg index was 8.7_1.4 outdoor and 7.5_1.4 treadmill, both significantly higher for outdoor running compared to treadmill. Maximal oxygen uptake estimates were 47.5_5.3 ml/kg/min outdoors and 49.8_5.0 ml/kg/min on the treadmill, significantly higher for treadmill running compared to outdoors.
Results date posted
| 2025 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifteen healthy males aged 18-22 years with exercise habits, mean age: 20.4_0.8 years, mean height: 172.5_7.0 cm, mean weight: 65.1_8.2 kg, mean BMI: 21.8_2.1 kg/m2.
Participant flow
Adverse events
Outcome measures
12-minute run test, heart rate, modified Borg index
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2025 | Year | 04 | Month | 02 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 08 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061435
