Tokyo, June 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062057) titled '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' on June 25.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Osaka Metropolitan University
Condition:
Condition - Pelvic Floor Dysfunctions (Urinary or Fecal Incontinence, Pelvic Organ Prolapse, Pelvic Girdle Pain) and Low Back Pain
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 50
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071007
Disclaimer: Curated by HT Syndication.