UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062057 |
|---|---|
| Receipt number | R000071007 |
| Scientific Title | Effect of a Physical Therapy Home-based Exercise Program on Pelvic Floor Dysfunction and Low Back Pain in Postpartum Women from the Brazilian Community in Japan |
| Date of disclosure of the study information | 2026/06/25 |
| Last modified on | 2026/06/25 17:40:39 |
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Basic information
Public title
Effect of a Physical Therapy Home-based Exercise Program on Pelvic Floor Dysfunction and Low Back Pain in Postpartum Women from the Brazilian Community in Japan
Acronym
BPPFDJ
Scientific Title
Effect of a Physical Therapy Home-based Exercise Program on Pelvic Floor Dysfunction and Low Back Pain in Postpartum Women from the Brazilian Community in Japan
Scientific Title:Acronym
BPPFDJ
Region
| Japan |
Condition
Condition
Pelvic Floor Dysfunctions (Urinary or Fecal Incontinence, Pelvic Organ Prolapse, Pelvic Girdle Pain) and Low Back Pain
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness and adherence to a structured home-based exercise program for the prevention and treatment of pelvic floor dysfunction and low back pain among Brazilian postpartum women living in Japan. The study also seeks to identify barriers and challenges related to access to pelvic floor rehabilitation services that those women may face in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Change in pelvic floor dysfunction symptoms will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) from baseline to 8 weeks after the start of the intervention period in both the intervention and control groups.
Key secondary outcomes
The following secondary outcomes will be assessed from baseline to 8 weeks after the start of the intervention period in both the intervention and control groups:
Pelvic Floor Impact Questionnaire-7 (PFIQ-7): to assess changes in pelvic floor-related quality of life; Oswestry Disability Index (ODI): to assess changes in low back pain-related disability; Numeric Pain Rating Scale (NPRS): to assess changes in pain intensity.
Exercise adherence will be assessed using a weekly adherence questionnaire throughout the 8-week intervention period among participants in the intervention group only.
Exploratory outcome:
In addition, potential barriers to accessing pelvic floor rehabilitation services among Brazilian postpartum women living in Japan will be explored using a self-developed questionnaire.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Intervention Group: Participants will perform an 8 week structured home-based exercise program delivered remotely, focusing on pelvic floor and core muscle strengthening, flexibility, mobility, posture, and breathing exercises. The program consists of three sessions per week, with each session lasting approximately 30 minutes.
Interventions/Control_2
Control Group: Participants will not receive the structured home-based exercise program during the study period and will continue their usual daily routines.
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
To be a Brazilian women living in Japan who experienced the postpartum period in Japan.
Aged between 18 and 45 years.
Within 12 months postpartum.
Having internet access and being able to use a smartphone, computer, or tablet device.
Presenting at least one symptom of pelvic floor dysfunction (e.g., urinary incontinence, pelvic organ prolapses, or sexual dysfunction) and/or low back pain or pelvic pain.
Providing voluntary informed consent to participate in the study.
Women are eligible to participate regardless of previous experience with pelvic floor rehabilitation before this study.
Key exclusion criteria
Women with medical contraindications to pelvic floor muscle training.
Pregnant women.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Morino |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
132-1 Morinomiya 2-chome, Joto-ku, Osaka-shi, Osaka
TEL
072-950-2111
saorim@omu.ac.jp
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Takahara Vasconcelos |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
132-1 Morinomiya 2-chome, Joto-ku, Osaka-shi, Osaka
TEL
070-8930-3033
Homepage URL
st25326r@st.omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee on Research Ethics, The Graduate School of Rehabilitation Sciences, Osaka Metropolitan Universtity
Address
3-7-30 Habikino, Habikino-City, Osaka, 583-8555, JAPAN
Tel
81-729-50-2111
iwata@omu.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
| 2026 | Year | 06 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 25 | Day |
Last modified on
| 2026 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071007
