UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054066 |
|---|---|
| Receipt number | R000059734 |
| Scientific Title | plication of Draw in maneuver for the Prevention of Low Back Pain and Urinary Incontinence in the Elderly in the Community: A Preliminary Intervention Study |
| Date of disclosure of the study information | 2024/09/27 |
| Last modified on | 2024/08/18 15:19:27 |
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Basic information
Public title
Application of Draw in maneuver for the Prevention of Low Back Pain and Urinary Incontinence in the Elderly in the Community: A Preliminary Intervention Study
Acronym
Application of Draw in maneuver for the Prevention of Low Back Pain and Urinary Incontinence in the Elderly in the Community: A Preliminary Intervention Study
Scientific Title
plication of Draw in maneuver for the Prevention of Low Back Pain and Urinary Incontinence in the Elderly in the Community: A Preliminary Intervention Study
Scientific Title:Acronym
plication of Draw in maneuver for the Prevention of Low Back Pain and Urinary Incontinence in the Elderly in the Community: A Preliminary Intervention Study
Region
| Japan |
Condition
Condition
Low Back Pain and Urinary Incontinence
Classification by specialty
| Orthopedics | Urology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the intervention effects of applying draw in maneuver for the prevention of low back pain and urinary incontinence to daily exercise and daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale, Oswestry Disability Index,International Consultation on Incontinence Questionnaire-Short Form
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The intervention group will receive Draw in maneuver for 4 weeks in the day service and in their daily life and daily exercise.
Interventions/Control_2
The control group will perform the usual exercise at the day service.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those determined to have symptoms of back pain or urinary incontinence on the VAS, ODI, or ICIQ-SF for the main outcome.
Key exclusion criteria
Those with cognitive impairment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jin |
| Middle name | |
| Last name | Ishibashi |
Organization
Seijoh University Graduate School
Division name
Division of Health Care Studies, Graduate School of Health Care Studies
Zip code
4760014
Address
2-172 Fukinodai,Tokai-shi,Aichi-ken,Japan
TEL
052-601-6000
m2270015@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Jin |
| Middle name | |
| Last name | Ishibashi |
Organization
Seijoh University Graduate School
Division name
Division of Health Care Studies, Graduate School of Health Care Studies
Zip code
4890964
Address
2-171-260 Uenoyamacho, Seto-shi, Aichi-ken Japan
TEL
08036501484
Homepage URL
jin.saku0120@gmail.com
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
Seijoh University
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
Seijoh University Graduate School
Address
2-172 Fukinodai Tokai Aichi Japan
Tel
052-601-6000
m2270015@seijoh-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
| 2024 | Year | 09 | Month | 27 | 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
38
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
Terminated
Date of protocol fixation
| 2023 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059734
