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

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 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


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

Value
https://center6.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