UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031440 |
|---|---|
| Receipt number | R000035891 |
| Scientific Title | Thermoregulation mechanism of able-bodied persons in upper limb exercise |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2023/03/06 19:40:43 |
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Basic information
Public title
Thermoregulation mechanism of able-bodied persons in upper limb exercise
Acronym
Thermoregulation mechanism of able-bodied persons in upper limb exercise
Scientific Title
Thermoregulation mechanism of able-bodied persons in upper limb exercise
Scientific Title:Acronym
Thermoregulation mechanism of able-bodied persons in upper limb exercise
Region
| Japan |
Condition
Condition
able-bodied persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the thermoregulation mechanism of the able-bodied persons during upper limb exercise under a hot environment.
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.
In the future, I want the athletes with disabilities to perform the same upper limb exercise, and I want to examine whether there is a difference in thermoregulatory mechanism compared to the able-bodied persons.
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. Persons with exercise history and exercise habits
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
734-8551
Address
1-2-3 kasumi minami-ku Hiroshima
TEL
082-257-5566
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
784-8551
Address
1-2-3 kasumi minami-ku Hiroshima
TEL
082-257-5566
Homepage URL
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
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=R000035891
