UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014534
Receipt number R000016905
Scientific Title Effective bathing for recovery from fatigue
Date of disclosure of the study information 2014/08/01
Last modified on 2021/03/12 10:46:16

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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 or person

Institute

Daito Bunka University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016905


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name