- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575490
Impact of Post-Cesarean Abdomino-Pelvic Training on Diastasis Recti and Sexual Function (APPT-S)
The Impact of Structured Postoperative Abdomino-Pelvic Power-Training on Diastasis Recti Abdominis, Pelvic Hemodynamics, and Sexual Function Following Cesarean Section: A Prospective, Randomized Controlled, Doppler Morphometric Analysis Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Background and Rationale:
Cesarean section (C-section) is a major surgical procedure that alters the integrity of the abdominal wall. Even if it avoids direct pelvic floor trauma associated with vaginal delivery, the combination of pregnancy-related mechanical stress and surgical incision often leads to Diastasis Recti Abdominis (DRA) and pelvic floor dysfunction. These conditions are frequently associated with reduced sexual function and lower quality of life in the postpartum period. While pelvic floor muscle training (PFMT) is well-studied, there is a lack of objective evidence regarding the impact of structured "Abdomino-Pelvic Power-Training" on tissue-level recovery and vascular perfusion. Study Objectives:
The primary objective of this prospective, randomized controlled study is to evaluate the efficacy of a 6-week structured rehabilitation program on inter-recti distance (IRD), pelvic hemodynamics, and sexual function in primiparous women following elective C-section. Methodology and Intervention:
A total of 160 participants will be recruited at their 6th-week postpartum visit at Harran University Hospital. Eligible participants will be randomized into two groups: Intervention Group: Participants will receive a 6-week structured abdomino-pelvic power-training protocol (including PFMT and core stabilization exercises). The program consists of weekly clinical visits and a prescribed home exercise regimen. Control Group: Participants will receive standard routine postpartum follow-up care without specific exercise training. Outcome Measures and Evaluation:
Assessments will be performed at baseline (6th week postpartum) and at the end of the intervention (3rd month postpartum). Morphometric Analysis: Inter-recti distance (IRD) will be measured using linear probe ultrasonography. Hemodynamic Assessment: Pelvic blood flow will be evaluated via Doppler ultrasonography, measuring Pulsatility Index (PI) and Resistance Index (RI) of the Uterine Artery and Vaginal Artery, as well as perfusion of the surgical scar tissue. Functional Assessment: Sexual function will be measured using the validated Female Sexual Function Index (FSFI) questionnaire. Statistical Analysis:
Data will be analyzed using SPSS software. Continuous variables will be compared using Independent Samples t-test or Mann-Whitney U test between groups, and Paired Samples t-test or Wilcoxon Signed-Rank test for within-group changes over time. Correlation between objective Doppler parameters and subjective FSFI scores will be evaluated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MEHMET İNCEBIYIK, MD, Asst. Prof.
- Phone Number: +905353374889
- Email: drmehmetincebiyik@gmail.com
Study Contact Backup
- Name: ismail palalı, PhD, Asst. Prof.
- Email: ismail.palali01@gmail.com
Study Locations
-
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HALİLİYE
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Sanliurfa, HALİLİYE, Turkey (Türkiye), 63300
- Harran University Research and Application Hospital
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Contact:
- MEHMET İNCEBIYIK, Assistant Professor, MD
- Phone Number: 05353374889
- Email: drmehmetincebiyik@gmail.com
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Contact:
- İsmail Palalı, PT, PhD
- Email: ismail.palali01@gmail.com
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Şanliurfa, HALİLİYE, Turkey (Türkiye), 63300
- Harran University Research and Application Hospital
-
Contact:
- MEHMET İNCEBIYIK
- Phone Number: 05353374889
- Email: drmehmetincebiyik@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Primiparous women (first-time mothers).
Women who have undergone an elective cesarean section.
Participants who are at their 6th week postpartum at the start of the study.
Aged between 18 and 45 years.
Volunteering to participate and capable of signing the informed consent form.
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Exclusion Criteria:
- Multiparous women (those with more than one delivery).
Women with a history of previous abdominal or pelvic surgery (other than the current C-section).
Presence of chronic diseases (e.g., uncontrolled diabetes, hypertension, or connective tissue disorders).
Any musculoskeletal or neurological condition that prevents participation in an exercise program.
History of pelvic organ prolapse or severe urinary incontinence prior to pregnancy.
Active pelvic or abdominal infection.
Participants who have already started a structured postpartum exercise program elsewhere.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group: Abdomino-Pelvic Power-Training
Participants in this arm will participate in a 6-week "Structured Abdomino-Pelvic Power-Training" program, starting at the 6th week postpartum. The intervention consists of: Clinical Sessions: Once-a-week supervised training sessions conducted at the hospital to ensure correct technique. Home Exercise Program: Prescribed daily exercises to be performed by the participant at home for the remaining 6 days of the week. Core Stabilization: Specific exercises targeting the rectus abdominis, obliques, and transversus abdominis muscles to reduce inter-recti distance (IRD). Pelvic Floor Muscle Training (PFMT): Structured contractions aimed at improving pelvic floor strength and hemodynamics. Monitoring: Progress will be monitored during weekly clinical visits, and the intensity will be adjusted based on participant tolerance. |
A 6-week structured exercise program including one weekly supervised clinical session and daily home exercises.
It focuses on core stabilization (rectus abdominis, obliques, transversus abdominis) to reduce inter-recti distance and Pelvic Floor Muscle Training (PFMT) to improve strength and hemodynamics.
|
|
Active Comparator: Control Group: Standard Postpartum Care
Participants in this arm will follow the standard routine postpartum care and follow-up protocol provided by the clinic.
They will not participate in the structured abdomino-pelvic or pelvic floor exercise program during the 6-week study period.
All clinical assessments, including ultrasound measurements for inter-recti distance, pelvic Doppler imaging, and the Female Sexual Function Index (FSFI) questionnaires, will be performed at the same time intervals as the intervention group (at the 6th week and 3rd month postpartum) to provide a comparative baseline for the study.
|
Participants will follow the routine clinical postpartum follow-up protocol.
This includes standard medical advice and assessments at the 6th week and 3rd month postpartum, without participation in the structured exercise program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Inter-recti Distance (IRD)
Time Frame: From baseline (6th week postpartum) to the completion of the exercise program (3rd month postpartum).
|
The distance between the medial borders of the two rectus abdominis muscles, measured in centimeters (cm) using linear probe ultrasonography to evaluate the severity of Diastasis Recti Abdominis (DRA).
|
From baseline (6th week postpartum) to the completion of the exercise program (3rd month postpartum).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HRÜ/26.04.16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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