UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036501 |
|---|---|
| Receipt number | 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 | 2026/03/08 12:29:19 |
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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
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
med811km@gmail.com
Sponsor or person
Institute
Wakayama medical university Department of rehabilitaion medicine
Institute
Department
Personal name
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
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
https://www.jstage.jst.go.jp/article/jjrmc/57/Autumn/57_S308/_pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjrmc/57/Autumn/57_S308/_pdf
Number of participants that the trial has enrolled
10
Results
Serum BDNF levels did not show a significant increase within the alternating bath group.
Results date posted
| 2026 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Selection Criteria
Males aged 20 years or older and 65 years or younger
Individuals who voluntarily wish to participate
Exclusion Criteria
Individuals with a history of cardiovascular, pulmonary, hepatic, or renal disease
Participant flow
Study Population: Healthy individuals
Study Design: Randomized crossover comparative trial
Target Enrollment: 10 participants
Ten participants completed measurements in each group, and outcome analysis utilized data from all 10 participants.
Adverse events
An increase in core body temperature may cause symptoms resembling heatstroke, including dizziness and headache.
If excessive core body temperature elevation is observed, take measures to normalize body temperature. If intolerable discomfort or pain occurs during measurement, immediately stop the experiment.
No adverse events were observed in this study.
Outcome measures
Primary Endpoint: Serum BDNF concentration at each blood sampling point
Secondary Endpoints: CBC, heart rate, blood pressure, core body temperature, cortisol, catecholamines
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 24 | Day |
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
| 2026 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041486
