UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040995 |
|---|---|
| Receipt number | R000046797 |
| Scientific Title | Effects on the body of para athletes caused by the temperature changes of a prosthesis and a wheelchair under the summer heat environment |
| Date of disclosure of the study information | 2020/07/06 |
| Last modified on | 2022/06/14 16:24:50 |
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Basic information
Public title
The study of countermeasures against summer heat for para athletes
Acronym
Countermeasures against summer heat for para athletes
Scientific Title
Effects on the body of para athletes caused by the temperature changes of a prosthesis and a wheelchair under the summer heat environment
Scientific Title:Acronym
Changes of the temperature of a prosthesis, a wheelchair and the body of para athletes under the summer heat environment
Region
| Japan |
Condition
Condition
Spinal cord injury, Amputation, others
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We determine the following, and para athletes play sports safely under summer heat environment.
1. Does the temperature of a wheelchair or prosthetic change by a radiant heat?
2. Does a athlete body temperature change by a wheelchair or prosthetic temperature change?
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body temperature
wheelchair or prosthetic temperature
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
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
An insulation sheet covers a wheelchair or prosthesis and monitor its on exercise
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Para sports history being more than one year
2.Use a wheelchair or prosthesis in sports
3.Outdoor sports athlete
Key exclusion criteria
1.No hospitalized more than four weeks from before on an assay date
2.For less than one month, nothing any injury and disease to be absent from training more than one week
3.Without the following complications
Mental disorder, a convulsive seizure, heart disorder, dysphagia, stomach and intestines obstruction disease, large intestine diverticulosis, inflammatory enteric disease, the disorder of the faucial reflex, esophageal disease, gastrointestinal resistance motility disturbance involving the ileus
4.The following things which are applicable to 7) from 1)
1)In any subject whose weight is less than eighty (80) pounds
2)In the presence of any known or suspected obstructive disease of the gastrointestinal tract, including but not limited to diverticulitis and inflammatory bowel disease
3)In any subject with previous gastrointestinal surgery
4)In any subject having felinization of the esophagus
5)In any subject who might undergo NMR/MRI scanning during the period that a pill sensor is within the body
6)In any subject with hypomotility disorders of the gastrointestinal tract, including but not limited to ileus
7)In any subject having a cardiac pacemaker or other implanted electromedical device
8)Others,An athlete who judges that a researcher is inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tatsuru |
| Middle name | |
| Last name | IBUSUKI |
Organization
Wakayama Medical University
Division name
Medical Center for Health and sports Science
Zip code
640-8033
Address
2-1, Honmachi, Wakayama city WAKAYAMA 640-8033 JAPAN
TEL
0734881933
tibusuki-2020@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuru |
| Middle name | |
| Last name | IBUSUKI |
Organization
Wakayama Medical University
Division name
Medical Center for Health and sports Science
Zip code
640-8033
Address
2-1, Honmachi, Wakayama city WAKAYAMA 640-8033 JAPAN
TEL
0734881933
Homepage URL
tibusuki-2020@umin.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
The DESCENTE and Ishimoto Foundation for the Promotion of Sports Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
0734410896
wa-rinri@wakayama-med.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
| 2020 | Year | 07 | Month | 06 | 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
8
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Amputees and spinal cord injured
Participant flow
Adverse events
None
Outcome measures
Core temperature, surface temperature, humidity, heart rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 04 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 05 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 03 | Day |
Last modified on
| 2022 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046797
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