UMIN-CTR Clinical Trial

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	9
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	2020 Year 04 Month 03 Day
Date of IRB	2020 Year 04 Month 03 Day
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	2021 Year 03 Month 17 Day

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