UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A research for the prevention from heat stroke in athlete with lower limb amputation
Title of the study (Brief title)	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	Yoshi-ichiro Kamijo
Organization	Wakayama Medical University
Division name	Department of Rehabilitation Medicine
Address	811-1 Kimiidera, Wakayama
TEL	073-441-0664
Email	yoshikmj@wakayama-med.ac.jp

Public contact
Name of contact person	Yoshi-ichiro Kamijo
Organization	Wakayama Medical University
Division name	Dept. of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000036024