UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031426 |
|---|---|
| Receipt number | R000035881 |
| Scientific Title | An intervention study for core temperature in persons with impairments during exercise and/or daily life |
| Date of disclosure of the study information | 2018/02/28 |
| Last modified on | 2020/03/18 16:14:40 |
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Basic information
Public title
An intervention study for core temperature in persons with impairments during exercise and/or daily life
Acronym
Core temperature in persons with impairments during daily activity
Scientific Title
An intervention study for core temperature in persons with impairments during exercise and/or daily life
Scientific Title:Acronym
Core temperature in persons with impairments during daily activity
Region
| Japan |
Condition
Condition
Persons with impairments
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our purpose is 1) assess a relationship between changes in body core temperature and exercise intensities or daily activities and 2) relation between heat or cold acclimation and blood volume in persons with impaired.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A relation between energy expenditure during exercise and/or daily life and core temperature
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom | Other |
Interventions/Control_1
persons with impairments
healthy control
Interventions/Control_2
a single, every 2 weeks, and every season
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person with over 20 y.o., who wish to participate in the free will, and who can communicates
Key exclusion criteria
Sever lower joint diseases, mental disorder, seizures, cardiovascular diseases, dysphagia, colon diverticulosis, inflammatory bowel diseases, esophageal diseases, ileus.
A persons with a pace maker, who will take a MRI scan while leaving a pill in the body, whose body weight is less than 36.3 kg, and who drank alcohol the day before the experiment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshi-ichiro |
| Middle name | |
| Last name | Kamijo |
Organization
Wakayama Medical University
Division name
Dept. of Rehabilitation Med.
Zip code
640-8341
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0664
yoshikmj@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshi-ichiro |
| Middle name | |
| Last name | Kamijo |
Organization
Wakayama Medical University
Division name
Dept. of Rehabilitation Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0664
Homepage URL
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1 Kimidera, Wakayama
Tel
073-447-2300
wa-rinri@wakayama-med.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 | 02 | Month | 28 | 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
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 01 | 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 | 22 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035881
