UMIN-CTR Clinical Trial

Basic information
Public title	Effective bathing for recovery from fatigue
Acronym	Effective bathing for recovery from fatigue
Scientific Title	Effective bathing for recovery from fatigue
Scientific Title:Acronym	Effective bathing for recovery from fatigue
Region	Japan

Condition
Condition	fatigue
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clearly effective bathing for recovery from fatigue
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	fatigue, blood lactic acid
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	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	bathing after just exercise, 42 degrees C
Interventions/Control_2	bathing after one hour of exercise, 42 degrees C
Interventions/Control_3	bathing after just exercise, 38 degrees C
Interventions/Control_4	bathing after one hour of exercise, 38 degrees C
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 and Female
Key inclusion criteria	healthy
Key exclusion criteria	inability to exercise
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Shinya Middle name Last name Hayasaka
Organization	Daito Bunka University
Division name	Department of Health Science
Zip code	355-8501
Address	560 Iwadono Higashimatsuyama Saitama Japan
TEL	0493-31-1558
Email	hayasaka@ic.daito.ac.jp

Public contact
Name of contact person	1st name Shinya Middle name Last name Hayasaka
Organization	Daito Bunka University
Division name	Department of Health Science
Zip code	355-8501
Address	560 Iwadono Higashimatsuyama Saitama Japan
TEL	0493-31-1558
Homepage URL
Email	hayasaka@ic.daito.ac.jp

Sponsor
Institute	Daito Bunka University
Institute
Department

Funding Source
Organization	Daito Bunka University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Daito Bunka University
Address	560 Iwadono Higashimatsuyama Saitama Japan
Tel	0493-31-1552
Email	nyushi@ic.daito.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	2014 Year 08 Month 01 Day

Related information
URL releasing protocol	https://doi.org/10.11390/onki.78.138
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.11390/onki.78.138
Number of participants that the trial has enrolled	10
Results	Blood lactate concentration. Blood lactate concentration: The blood lactate concentration before the start of the experiment was significantly higher in experiment A (6.6+-4.7 mmol/L) than in experiment B (2.0+-1.4 mmol/L) (p = 0.02), but there was no difference after the exercise load and at the end of the experiment. There was no difference in the amount of blood lactate lowered and the rate of blood lactate lowering between experiments A and B.
Results date posted	2021 Year 03 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy 10 men
Participant flow	After 10 healthy adult males were given written explanations and signed written consent, the following experiments A and B were conducted after increasing the blood lactate concentration by the Bruce method using a treadmill exercise load. (A) After 60 minutes of rest after the exercise load, the subjects took a full-body bath in warm tap water at 38C for 10 minutes. (B) Immediately after the exercise, the subjects took a full-body bath in warm tap water at 38C for 10 minutes and rested for 60 minutes. Body temperature, blood pressure, heart rate, and blood lactate concentration were measured (1) before the start of the experiment, (2) after the exercise load, and (3) at the end of the experiment. In addition, the amount and rate of decrease in blood lactate concentration from after the exercise to the end of the experiment were calculated.
Adverse events	nothing
Outcome measures	Body temperature, blood pressure, heart rate, and blood lactate concentration were measured (1) before the start of the experiment, (2) after the exercise load, and (3) at the end of the experiment. In addition, we calculated the amount and rate of decrease in blood lactate concentration from the time of exercise to the end of the experiment.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 13 Day
Date of IRB	2014 Year 05 Month 19 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2015 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	2014 Year 07 Month 11 Day
Last modified on	2021 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016905