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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031426
Receipt No. 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 2019/02/20

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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
Middle name
Last name Yoshi-ichiro Kamijo
Organization Wakayama Medical University
Division name Dept. of Rehabilitation Med.
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
Institute Wakayama Medical University
Institute
Department

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
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 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
Anticipated trial start date
2018 Year 02 Month 22 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 22 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035881

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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