UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048795 |
|---|---|
| Receipt number | R000055595 |
| Scientific Title | Effect on leg edema and stress reduction of thermal equipment using far-infrared rays |
| Date of disclosure of the study information | 2022/08/30 |
| Last modified on | 2022/08/30 16:53:57 |
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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
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
yuko.matsui@komatsu-u.ac.jp
Sponsor or person
Institute
Komatsu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055595
