UMIN-CTR Clinical Trial

Basic information
Public title	A Study to Determine the Effects of Repeated Hot and Cold Baths on Muscle Relaxation.
Acronym	A study on the effect of alternating baths on muscle relaxation.
Scientific Title	A study on the effects of hot and cold alternating stimulation on post-exercise muscle fatigue recovery and relaxation of resting muscle tone.
Scientific Title:Acronym	Study on the effect of alternating bathing on muscle fatigue recovery.
Region	Japan

Condition
Condition	Muscle fatigue and muscle tone
Classification by specialty	Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	With the increasing awareness of sports and exercise in modern society, the alternating bath is widely recognized as a method of recovering muscle fatigue after exercise. On the other hand, alternating baths require two bathtubs and the temperature of the water changes each time you take a bath. There are also hygiene issues when using a large number of people, and difficulties in adapting to people with disabilities. Therefore, a means of providing hot and cold stimulation that can more easily recover from fatigue is being sought. In this study, we will investigate whether thermoelectric devices and electric warmer and other simple hot and cold stimuli can be used for fatigue recovery.
Basic objectives2	Others
Basic objectives -Others	feasibility study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle stiffness, fatigue, and stiffness data that can be obtained with the muscle hardness tester/lower limb extension elevation test. Motor function/lifestyle data/fatigue/stiffness questionnaire.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	warm and cold stimulation
Interventions/Control_2
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	15 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Volunteers who gave informed consent and obtained consent before conducting the study. The target age is 15 years or older.
Key exclusion criteria	Volunteers who gave informed consent before conducting the study and were rejected. In addition, patients are excluded if they have a pacemaker that is not compatible with MRI, if they have metal in their body such as a pacemaker or a cerebral artery clip, or if they are claustrophobic or otherwise unable to undergo normal MRI.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takeo Middle name Last name Nagura
Organization	Keio University
Division name	School of medicine
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-5363-3812
Email	nagura@keio.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Nakashima
Organization	Keio University
Division name	School of medicine
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-5363-3812
Homepage URL
Email	nakashima@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio 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	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi, Shinjuku, Tokyo
Tel	0353633812
Email	med-rinri-jimu@adst.keio.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	2020 Year 05 Month 01 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 05 Month 01 Day
Date of IRB	2020 Year 08 Month 31 Day
Anticipated trial start date	2020 Year 08 Month 31 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	2020 Year 04 Month 07 Day
Last modified on	2021 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045710