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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041726
Receipt No. R000046164
Scientific Title Relationship between lower limb swelling and menstrual cycle in adult women
Date of disclosure of the study information 2020/09/10
Last modified on 2020/09/08

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Basic information
Public title Relationship between lower limb swelling and menstrual cycle in adult women
Acronym Relationship between lower limb swelling and menstrual cycle in adult women
Scientific Title Relationship between lower limb swelling and menstrual cycle in adult women
Scientific Title:Acronym Relationship between lower limb swelling and menstrual cycle in adult women
Region
Japan

Condition
Condition Swelling of the lower limbs
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to lead to the construction of appropriate preventive actions and care for swelling of the lower limbs, which is said to be one of the indefinite complaints of women, we objectively and subjectively evaluate the occurrence of swelling of the lower limbs in each period of the menstrual cycle.The purpose is to obtain basic data on the menstrual cycle and swelling of the lower limbs.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lower leg volume
Key secondary outcomes Lower leg circumference, leg muscle hardness, leg impedance value, leg swelling

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 For one subject, the follicular phase of the menstrual cycle, the luteal phase, the menstrual phase, in this study, we evaluate the occurrence of swelling of the lower limbs after sitting for 60 minutes (up to 120 minutes) in the 3rd period of (1) menstruation period. The experiment is conducted during the same time period (starting from 8:30 to 9:00) on each day of each menstrual cycle. On the experimental day, depending on the subject's menstrual cycle status, the follicular phase is a day from 10 days to 3 days before ovulation, the luteal phase is a day from 7 days to 5 days before the start of menstruation, and the menstrual cycle is a start of menstruation. Set from one day to the third day.
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
20 years-old <=
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria 1.Those who have no underlying illness
2.Those who have no history of gynecological diseases and have a stable menstrual cycle.
3. Women over 20 and under 40
4. Person who has obtained written consent
Key exclusion criteria 1. Those who are pregnant or may become pregnant
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Nobuko
Middle name
Last name Hashiguchi
Organization Department of Health Sciences, Kyushu University School of Medicine
Division name Department of Health Sciences, Kyushu University School of Medicine
Zip code 812-8582
Address 3-1-1, Madade, Higashi-ku, Fukuoka-shi
TEL 092-642-6714
Email n-hashi@hs.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Nobuko
Middle name
Last name Hashiguchi
Organization Department of Health Sciences, Kyushu University School of Medicine
Division name Department of Health Sciences, Kyushu University School of Medicine
Zip code 812-8582
Address 3-1-1, Madade, Higashi-ku, Fukuoka-shi
TEL 092-642-6714
Homepage URL
Email n-hashi@hs.med.kyushu-u.ac.jp

Sponsor
Institute Department of Health Sciences, Kyushu University School of Medicine
Institute
Department

Funding Source
Organization None
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 Department of Health Sciences, Kyushu University School of Medicine
Address 3-1-1, Madade, Higashi-ku, Fukuoka-shi
Tel 092-642-6714
Email n-hashi@hs.med.kyushu-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
2020 Year 09 Month 10 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2020 Year 05 Month 30 Day
Last follow-up date
2021 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 09 Month 08 Day
Last modified on
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046164

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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