UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031554 |
|---|---|
| Receipt number | R000036024 |
| Scientific Title | A research for the prevention from heat stroke in athlete with lower limb amputation |
| Date of disclosure of the study information | 2018/03/02 |
| Last modified on | 2019/02/19 21:11:42 |
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Basic information
Public title
A research for the prevention from heat stroke in athlete with lower limb amputation
Acronym
Prevention from heat stroke in lower-limb amputatees
Scientific Title
A research for the prevention from heat stroke in athlete with lower limb amputation
Scientific Title:Acronym
Prevention from heat stroke in lower-limb amputatees
Region
| Japan |
Condition
Condition
lower limb amputation
Classification by specialty
| Rehabilitation medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study changes in body core temperature and to assess effects of body cooling on core temperature, a decrease in body weight, urine specific gravity, and subjective thermal sensation during exercise in summer in athletes with lower limb amputation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body core temperature
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Cooling by ingesting ice slurry
Interventions/Control_2
no ingestion of ice slurry
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
1) athletes who do disciplines as followings over 6 months: amputee soccer,
triathlon, and wheelchair basketball, marathon, and tennis
2) athletes who consent is obtained with documents for participating hthe present study
Key exclusion criteria
1) severe lower limb joint disease
2) mental illness, seizures, cardiovascular diseases, dysphagia, obstructive disease of the gastrointestinal, colon diverticulum, inflammatory diseases, failure of the gag reflex, surgery history of gastrointestinal, disease of the esophagus, ileus and low motility disorders of the gastrointestinal
3) a person who is getting MRI scan before a pill sensor is excreted
4) a person who has a pacemaker
5) a person whose body weight is less than 36.3 kg
6) a person who is judged as unfit for the present study by medical doctors
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshi-ichiro Kamijo |
Organization
Wakayama Medical University
Division name
Department of Rehabilitation Medicine
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0664
yoshikmj@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshi-ichiro Kamijo |
Organization
Wakayama Medical University
Division name
Dept. of Rehabilitation Medicine
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0664
Homepage URL
yoshikmj@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroshima University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 03 | Month | 02 | 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
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036024
