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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031441
Receipt No. R000035898
Scientific Title Prevention of heat stroke for athletes with lower limb amputation
Date of disclosure of the study information 2018/03/01
Last modified on 2018/08/29

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Basic information
Public title Prevention of heat stroke for athletes with lower limb amputation
Acronym Prevention of heat stroke for athletes with lower limb amputation
Scientific Title Prevention of heat stroke for athletes with lower limb amputation
Scientific Title:Acronym Prevention of heat stroke for athletes with lower limb amputation
Region
Japan

Condition
Condition lower limb amputation
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to elucidate the thermoregulation mechanism of the lower limb amputees during exercise under a hot environment and to propose preventive measures against heat stroke during sports of lower limb amputees.

In addition, we also clarify the effectiveness of body cooling using ice slurry which has been attracting attention as improving exercise capacity in recent years.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Body core temperture
Key secondary outcomes Body weight, urine specific gravity, heart rate, skin temperature, rating of perceived exertion, thermal sensation

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ice slurry is taken in an amount of 7.5 g * body weight (kg) 30 minutes before exercise.
Interventions/Control_2 The untreated control group ingests the same amount of water as the ice slurry 30 minutes before exercise.
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. Person who has more than half a year of competition history of either amputee football, triathlon, wheelchair basketball, wheelchair tennis, or wheelchair marathon
2. Person who obtains consent in writing on participation of this research
Key exclusion criteria 1. Persons who have severe upper limb or lower limb joint disease
2. Persons who have the following complications or past history
Mental disorders, convulsive seizures and seizure disorders, heart diseases, swallowing disorders, gastrointestinal obstructive diseases, colon diverticulosis, inflammatory bowel diseases, disorders of gag reflex, gastrointestinal surgical history, esophageal diseases, Gastrointestinal hypomotility disorder including ileus
* Including that family in case of Crohn's disease
3. Persons who are likely to undergo nuclear magnetic resonance (NMR) or MRI scanning while the pill sensor is in the body
4. Persons who have a cardiac pacemaker or other implantable electrical medical device
5. Persons whose weight is less than 80 pounds (36.3 kg)
6. Others who are deemed inappropriate for the research researcher or research sharing person to conduct this research
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Kimura
Organization Hiroshima University Hospital
Division name Department of Rehabilitation
Zip code
Address 1-2-3 kasumi minami-ku Hiroshima
TEL 082-257-5566
Email luna@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouki Fukuhara
Organization Hiroshima University Hospital
Division name Division of Rehabilitation, Department of Clinical Practice and Support
Zip code
Address 1-2-3 kasumi minami-ku Hiroshima
TEL 082-257-5566
Homepage URL
Email kouki@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization Hiroshima University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Wakayama Medical University
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 01 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 15 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 02 Month 23 Day
Last modified on
2018 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035898

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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