- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: MEHMET İNCEBIYIK, MD, Asst. Prof.
- Telefonnummer: +905353374889
- E-Mail: drmehmetincebiyik@gmail.com
Studieren Sie die Kontaktsicherung
- Name: ismail palalı, PhD, Asst. Prof.
- E-Mail: ismail.palali01@gmail.com
Studienorte
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HALİLİYE
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Sanliurfa, HALİLİYE, Türkei (türkiye), 63300
- Harran University Research and Application Hospital
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Kontakt:
- MEHMET İNCEBIYIK, Assistant Professor, MD
- Telefonnummer: 05353374889
- E-Mail: drmehmetincebiyik@gmail.com
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Kontakt:
- İsmail Palalı, PT, PhD
- E-Mail: ismail.palali01@gmail.com
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Şanliurfa, HALİLİYE, Türkei (türkiye), 63300
- Harran University Research and Application Hospital
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Kontakt:
- MEHMET İNCEBIYIK
- Telefonnummer: 05353374889
- E-Mail: drmehmetincebiyik@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
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Aktiver Komparator: 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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Inter-recti Distance (IRD)
Zeitfenster: From baseline (6th week postpartum) to the completion of the exercise program (3rd month postpartum).
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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).
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From baseline (6th week postpartum) to the completion of the exercise program (3rd month postpartum).
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- HRÜ/26.04.16
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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