UMIN-CTR Clinical Trial

Basic information
Public title	Effect on leg edema and stress reduction of thermal equipment using far-infrared rays
Acronym	Effect on leg edema and stress reduction of thermal equipment using far-infrared rays
Scientific Title	Effect on leg edema and stress reduction of thermal equipment using far-infrared rays
Scientific Title:Acronym	Effect on leg edema and stress reduction of thermal equipment using far-infrared rays
Region	Japan

Condition
Condition	Healthy women
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects on leg edema and autonomic nervous activity and mood states of a far-infrared (FIR) heater that heats the feet with ceramic balls
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	low-frequency component (LF)/high-frequency component (HF) during experiment
Key secondary outcomes	leg circumference

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	Device,equipment
Interventions/Control_1	Participants undergo foot warming for 15 minutes in a seated position
Interventions/Control_2	Participants sit down for 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	65 years-old >
Gender	Female
Key inclusion criteria	Eligible persons who work for more than 8 hours and have swelling of the lower leg
Key exclusion criteria	Individuals on cardiovascular medications, receiving outpatient care, or with a sensory disorder or injury of the legs
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Matsui
Organization	Komatsu University
Division name	Fuculty of Health Sciences, Department of Nursing
Zip code	9230961
Address	14-1 Mukaimotoorimachi, Komatsu, Ishikawa
TEL	0761483177
Email	yuko.matsui@komatsu-u.ac.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name Matsui
Organization	Komatsu University
Division name	Fuculty of Health Sciences, Department of Nursing
Zip code	9230961
Address	14-1 Mukaimotoorimachi, Komatsu, Ishikawa
TEL	0761483177
Homepage URL
Email	yuko.matsui@komatsu-u.ac.jp

Sponsor
Institute	Komatsu University
Institute
Department

Funding Source
Organization	Yumeron Kurokawa Co
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Komatsu University
Address	14-1, Mukaimotorimachi, Komatsu, Ishikawa, Japan
Tel	0761483177
Email	yuko.matsui@komatsu-u.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	2022 Year 08 Month 30 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	24
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	Completed
Date of protocol fixation	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 09 Month 10 Day
Anticipated trial start date	2020 Year 03 Month 11 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	2022 Year 08 Month 30 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055595