UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028613 |
|---|---|
| Receipt number | R000032748 |
| Scientific Title | Research on the physiological responses during physical activity with fire-fighting gears |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2025/04/01 11:27:44 |
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Basic information
Public title
Research on the physiological responses during physical activity with fire-fighting gears
Acronym
Physiological responses during physical activity with fire-fighting gears
Scientific Title
Research on the physiological responses during physical activity with fire-fighting gears
Scientific Title:Acronym
Physiological responses during physical activity with fire-fighting gears
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the estimation of the increase in body core temperature from physical characteristics, environmental condition, inner-clothing temperature, and physical activity.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the responses in thermoregulatory, respiratory, and cardiovascular responses during physical activity with fire-fighting gears and to verify the estimation of the increase in body core temperature from physical characteristics, environmental condition, inner-clothing temperature, and physical activity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Esophageal temperature, skin temperature, inner-clothing temperature, physical activity, physical characteristics
The estimation of the increase in body core temperature is analyzed with multi-regression analysis and Bland-Altman plot method.
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Walking exercise on the treadmill (1.5km/h, 3.0km/h, 4.5km/h, 6.0km/h, 9 minutes each): 5% grade
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1) age <= 20 years old to > 65 years old at the time of informed consent
2) volunteers who are fully informed of and understand the objectives, procedures, and possible risks of the study and provide the written voluntary consent to participate in the study.
Key exclusion criteria
1) Diseases which need physical work restriction
2) Cardiovascular diseases, arrhythmia
3) Metabolic and endocrine disease
4) Hypertension (resting blood pressure, SBP > or = 160 mmHg, DBP > or = 100)
5) Ineligible by a medical interview
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kazunobu |
| Middle name | |
| Last name | Okazaki |
Organization
Osaka city university graduate school of medicine
Division name
Environmental physiology for exercise
Zip code
558-8585
Address
3-3-138 Sugimoto, Sumiyoshi, Osaka, 558-8585 Japan
TEL
06-6605-2950
okazaki@sports.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kazunobu |
| Middle name | |
| Last name | Okazaki |
Organization
Osaka city university graduate school of medicine
Division name
Environmental physiology for exercise
Zip code
558-8585
Address
1-4-3 Asahimachi, Abeno, Osaka, 558-8585 Japan
TEL
06-6645-2121
Homepage URL
okazaki@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka city university
Institute
Department
Personal name
Funding Source
Organization
Osaka city university graduate school of medicine, Environmental Physiology for Exercise
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
Osaka city university
Address
1-4-3 Asahi-machi, Abano, Osaka, Japan
Tel
06-6645-3457
okazaki@sports.osaka-cu.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
| 2017 | Year | 08 | 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
24
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
Main results already published
Date of protocol fixation
| 2017 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032748
