UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033441 |
|---|---|
| Receipt number | R000038114 |
| Scientific Title | Relationship between urinary incontinence and physical activity in middle-aged and elderly women |
| Date of disclosure of the study information | 2018/07/20 |
| Last modified on | 2024/01/23 14:53:22 |
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Basic information
Public title
Relationship between urinary incontinence and physical activity in middle-aged and elderly women
Acronym
Relation between urinary incontinence and physical activity level
Scientific Title
Relationship between urinary incontinence and physical activity in middle-aged and elderly women
Scientific Title:Acronym
Relation between urinary incontinence and physical activity level
Region
| Japan |
Condition
Condition
Middle and order people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between urinary incontinence and physical activity and investigate and examine the basic data to develop a pelvic floor muscle training program considering the amount of physical activity.
Basic objectives2
Others
Basic objectives -Others
Investigation of basic data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary incontinence symptom evaluation items
Key secondary outcomes
physical activity, motor function
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
healthy female
Key exclusion criteria
Severe respiratory diseases,Severe cardiovascular diseases, Severe orthopedic diseases, Severe gynecological diseases, Severe urological diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Akiko |
Organization
Hyogo University of health sciences
Division name
Facalty of Rehabilitation
Zip code
6508530
Address
6-3-1 minatojima cyuo-ku kobe
TEL
0783043189
moakiko@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Mori |
Organization
Hyogo University of health sciences
Division name
Facalty of Rehabilitation
Zip code
6508530
Address
6-3-1 minatojima cyuo-ku kobe
TEL
0783043189
Homepage URL
moakiko@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo University of health sciences
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from Japan Society for the Promotion of Science
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
Hyogo Medical University Ethics Review Board
Address
1-3-6
Tel
0783043000
rinri-2@hyo-med.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
| 2018 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
For the spread of COVID-19 infection
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 | 07 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment through target company collaboration practice center
Management information
Registered date
| 2018 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038114
