UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037609 |
|---|---|
| Receipt number | R000042878 |
| Scientific Title | Relationship between pelvic alignment, pelvic floor muscle strength, and menstrual symptoms |
| Date of disclosure of the study information | 2019/08/06 |
| Last modified on | 2019/08/06 17:38:43 |
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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
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
y.kajiwara@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042878
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
