UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040995
Receipt No. 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 2020/07/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tibusuki-2020@umin.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Email 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
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
2020 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2021 Year 08 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
2020 Year 07 Month 03 Day
Last modified on
2020 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046797

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.