UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037781
Receipt No. 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 (Ver. 3)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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
Email 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
Email ohko-h@seijoh-u.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043087