UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037781 |
|---|---|
| Receipt number | R000043087 |
| Scientific Title | Effect of exercise therapy combined with hyperthermia on blood BDNF concentration in healthy young men |
| Date of disclosure of the study information | 2019/08/23 |
| Last modified on | 2020/08/24 13:49:23 |
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Basic information
Public title
Effect of exercise therapy combined with hyperthermia on blood BDNF concentration in healthy young men
Acronym
Development of exercise therapy to increase BDNF
Scientific Title
Effect of exercise therapy combined with hyperthermia on blood BDNF concentration in healthy young men
Scientific Title:Acronym
Effect of exercise therapy combined with hyperthermia on blood BDNF concentration in healthy young men
Region
| Japan |
Condition
Condition
young healthy men
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the immediate effect of exercise therapy combined with hyperthermia on blood BDNF concentration in healthy young men.
Basic objectives2
Others
Basic objectives -Others
It has been reported that long-term exercise (10 weeks or longer) increases blood BDNF at rest with certainty, and a consensus has been reached. However, the exercise method and exercise load which surely increase blood BDNF by the execution of one time exercise have not been clarified, and it is unclear. In the healthy subject, the time over 30 minutes is required at the load over about 70% of the maximum oxygen intake, but the clinical application is difficult for the elderly and the person with the disability after the disease because the load is high. In order to enable clinical application, it is necessary to establish a single exercise method in which blood BDNF increases surely while exercise load quantity and exercise time are decreased.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum and plasma brain-derived neurotrophic factor (BDNF; brain-derived neurotrophic factor) immediately after 15 minutes of warm bath exercise therapy
Key secondary outcomes
Plasma cortisol, lactic acid, Serum S 100 .BETA., neuron-specific enolase (NSE; neuron-specificenolase), Irisin, P selectin (CD 62 P), CBC (CBC; complete blood count), central temperature (esophageal temperature), blood pressure, heart rate, perceived exertion (Borg Scale), water temperature
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
| Maneuver |
Interventions/Control_1
Bicycle ergometer (60% of maximal oxygen uptake) 15 minutes in subjugated water at 40'C
Interventions/Control_2
40'C, subjugated water 15 minutes
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1.20-30age
2.a person able to communicate (No cognitive or higher brain dysfunction)
3.Those who wish to participate voluntarily
Key exclusion criteria
Persons with diabetes mellitus, heart disease, chronic inflammatory disease, or skin disease.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Umemoto |
| Middle name | |
| Last name | Yasunori |
Organization
Wakayama Medical University
Division name
rehabilitation medicine
Zip code
6418509
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0664
yumemoto@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ohko |
| Middle name | |
| Last name | Hiroshi |
Organization
Wakayama Medical University
Division name
rehabilitation medicine
Zip code
6418509
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0664
Homepage URL
ohko-h@seijoh-u.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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 Medical University Ethics Review Committee
Address
811-1 Kimiidera, Wakayama City
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
| 2019 | Year | 08 | Month | 23 | 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
10
Results
The serum BDNF concentration significantly increased immediately after the HOI-ex task and remained significantly increased 15 min after the task.
No changes in serum BDNF concentration were observed during the HOI experiment.
Comparison of the serum BDNF concentration HOI and HOI-ex tasks showed higher concentrations after the HOI-ex task than after the HOI task, and the difference was statistically significant.
Results date posted
| 2020 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None.
Outcome measures
Plasma cortisol, lactic acid, Serum S 100 .BETA., neuron-specific enolase (NSE; neuron-specificenolase), Irisin, P selectin (CD 62 P), CBC (CBC; complete blood count), central temperature (esophageal temperature), blood pressure, heart rate, perceived exertion (Borg Scale), water temperature
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2019 | Year | 08 | Month | 23 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043087
