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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031554
Receipt No. 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

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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
Email 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
Email yoshikmj@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036024

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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