UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between pelvic alignment, pelvic floor muscle strength, and menstrual symptoms
Acronym	Relationship between pelvic alignment, pelvic floor muscle strength, and menstrual symptoms
Scientific Title	Relationship between pelvic alignment, pelvic floor muscle strength, and menstrual symptoms
Scientific Title:Acronym	Relationship between pelvic alignment, pelvic floor muscle strength, and menstrual symptoms
Region	Japan

Condition
Condition	healthy and young women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate that the relationship between pelvic floor muscle strength and asymmetry of pelvic tilt or difference in pelvic ring circumstance between standing position and supine position. To research the relationship between these pelvic alignment and menstrual symptoms.
Basic objectives2	Others
Basic objectives -Others	To evaluate that self-exercise improves the symmetry of pelvic tilt and menstrual symptoms.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	difference in degree of left-right innominatal bone tilt difference in circumstance between load position and non-load position pelvic floor muscle function menstrual syndrome muscle tightness
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	Self-exercise(stretching) 12 weeks 5 times/week
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	18 years-old <=
Age-upper limit	40 years-old >
Gender	Female
Key inclusion criteria	To have cyclic menstrual discharge
Key exclusion criteria	To do pelvic floor muscle training regularly
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yuu Middle name Last name Kajiwara
Organization	Kio University
Division name	Faculty of Health Science
Zip code	635-0832
Address	4-2-2 Umaminaka, Korho-cho, Kitakatsuragi-gun, Nara
TEL	0745-54-1601
Email	y.kajiwara@kio.ac.jp

Public contact
Name of contact person	1st name Yuu Middle name Last name Kajiwara
Organization	Kio University
Division name	Faculty of Health Science
Zip code	635-0832
Address	4-2-2 Umaminaka, Korho-cho, Kitakatsuragi-gun, Nara
TEL	0745-54-1601
Homepage URL
Email	y.kajiwara@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kio University
Address	4-2-2 Umaminaka, Korho-cho, Kitakatsuragi-gun, Nara
Tel	0745-54-1601
Email	soumu@kio.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	2019 Year 08 Month 06 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	2019 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 26 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	2019 Year 08 Month 06 Day
Last modified on	2019 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042878