UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031441
Receipt number 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 2023/03/06 19:43:35

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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 HIROAKI
Middle name
Last name KIMURA

Organization

Hiroshima University Hospital

Division name

Department of Rehabilitation

Zip code

731-8554

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 KOUKI
Middle name
Last name FUKUHARA

Organization

Hiroshima University hospital

Division name

Division of Rehabilitation, Department of Clinical Practice and Support

Zip code

731-8554

Address

1-2-3 kasumi minami-ku Hiroshima

TEL

082-257-5566

Homepage URL


Email

kouki@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University Hospital

Institute

Department

Personal name



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

Hiroshima University hospital

Address

1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan

Tel

082-257-5596

Email

hugcp@hiroshima-u.ac.jp


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

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

18

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

2017 Year 12 Month 10 Day

Date of IRB

2018 Year 02 Month 14 Day

Anticipated trial start date

2018 Year 02 Month 15 Day

Last follow-up date

2022 Year 07 Month 31 Day

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

2023 Year 03 Month 06 Day



Link to view the page

Value
https://center6.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