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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036501
Receipt No. R000041486
Scientific Title Examination of the influence of blood BDNF changes by contrast bath in healthy people
Date of disclosure of the study information 2019/05/01
Last modified on 2019/04/13

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Basic information
Public title Examination of the influence of blood BDNF changes by contrast bath in healthy people
Acronym Examination of the influence of blood BDNF changes by contrast bath in healthy people
Scientific Title Examination of the influence of blood BDNF changes by contrast bath in healthy people
Scientific Title:Acronym Examination of the influence of blood BDNF changes by contrast bath in healthy people
Region
Japan

Condition
Condition healthy people
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the influence of contrast bath on blood BDNF changes in healthy adult men.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concentration of Blood BDNF
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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
Other
Interventions/Control_1 contrast bath
Interventions/Control_2 bathing in 30 degree
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
65 years-old >=
Gender Male
Key inclusion criteria 1 Men aged 20 to 65
2 People who want to participate by oneself
Key exclusion criteria People who has a history of cardiovascular, lung, liver, kidney disease
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Fumihiro
Middle name
Last name Tajima
Organization Wakayama medical university
Division name Department of rehabilitaion medicine
Zip code 641-8509
Address 811-1 Kimiidera,Wakayama City,Wakayama Prefecture
TEL 073-441-0664
Email fumi@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Kota
Middle name
Last name Murai
Organization Wakayama medical university
Division name Department of rehabilitaion medicine
Zip code 641-8509
Address 811-1 Kimiidera,Wakayama City,Wakayama Prefecture
TEL 073-441-0664
Homepage URL
Email med811km@gmail.com

Sponsor
Institute Wakayama medical university Department of rehabilitaion medicine
Institute
Department

Funding Source
Organization Wakayama medical university Department of rehabilitaion medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Wakayama Prefectural University of Medicine Ethics Review Committee
Address 811-1 Kimiidera,Wakayama City,Wakayama Prefecture
Tel 073-441-0897
Email 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
2019 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2024 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 13 Day
Last modified on
2019 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041486

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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