[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640549":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":24,"studyPopulation":13,"armGroups":25,"interventions":38,"overallOfficials":13,"centralContacts":47,"locations":56,"responsibleParty":80,"collaborators":13,"id":84,"slug":13,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":13,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":112,"whyStopped":13,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Harran University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Inter-recti Distance (IRD)","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).",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Model Description This is a prospective, two-arm, parallel-group randomized controlled trial.\n\nRandomization: Participants who meet the inclusion criteria will be randomly assigned to either the Intervention Group or the Control Group with a 1:1 allocation ratio. Randomization will be performed using a computer-generated random sequence to ensure unbiased distribution.\n\nIntervention Arm: Participants in this group will undergo a 6-week \"Structured Abdomino-Pelvic Power-Training\" protocol. This includes core stabilization and pelvic floor muscle exercises, initiated at the 6th week postpartum.\n\nControl Arm: Participants in this group will receive standard postpartum care and follow-up without any structured exercise intervention.\n\nFollow-up: Both groups will be evaluated at baseline (6th week postpartum) and immediately following the 6-week study period (3rd month postpartum) to compare clinical, morphometric, and hemodynamic outcomes.","TREATMENT",{"masking":20,"maskingDescription":21,"whoMasked":22},"SINGLE","The primary investigator and the radiologist (outcomes assessor) performing the ultrasonographic measurements and Doppler evaluations will be blinded to the group assignments of the participants. To ensure effective masking, the participant will be instructed not to disclose their involvement in the exercise program to the assessor during the clinical follow-up and measurement sessions. Data analysis will be conducted by a statistician who is also masked to the allocation groups.",[23],"OUTCOMES_ASSESSOR","Background and Rationale:\n\nCesarean 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:\n\nThe 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:\n\nA 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:\n\nAssessments 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:\n\nData 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.",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"Intervention Group: Abdomino-Pelvic Power-Training","EXPERIMENTAL","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:\n\nClinical Sessions: Once-a-week supervised training sessions conducted at the hospital to ensure correct technique.\n\nHome Exercise Program: Prescribed daily exercises to be performed by the participant at home for the remaining 6 days of the week.\n\nCore Stabilization: Specific exercises targeting the rectus abdominis, obliques, and transversus abdominis muscles to reduce inter-recti distance (IRD).\n\nPelvic Floor Muscle Training (PFMT): Structured contractions aimed at improving pelvic floor strength and hemodynamics.\n\nMonitoring: Progress will be monitored during weekly clinical visits, and the intensity will be adjusted based on participant tolerance.",[31],"Other: Abdomino-Pelvic Power-Training Program",{"label":33,"type":34,"description":35,"interventionNames":36},"Control Group: Standard Postpartum Care","ACTIVE_COMPARATOR","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.",[37],"Other: Standard Postpartum Follow-up",[39,43],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"Abdomino-Pelvic Power-Training Program","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.",[27],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":13},"Standard Postpartum Follow-up","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.",[33],[48,53],{"name":49,"role":50,"phone":51,"phoneExt":13,"email":52},"MEHMET İNCEBIYIK, MD, Asst. Prof.","CONTACT","+905353374889","drmehmetincebiyik@gmail.com",{"name":54,"role":50,"phone":13,"phoneExt":13,"email":55},"ismail palalı, PhD, Asst. Prof.","ismail.palali01@gmail.com",[57,75],{"facility":58,"status":13,"city":59,"state":60,"zip":61,"country":62,"countryCode":13,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Harran University Research and Application Hospital","Sanliurfa","HALİLİYE","63300","Turkey (Türkiye)",{"type":64,"coordinates":65},"Point",[66,67],38.79392,37.16708,{"lat":67,"lon":66},[70,73],{"name":71,"role":50,"phone":72,"phoneExt":13,"email":52},"MEHMET İNCEBIYIK, Assistant Professor, MD","05353374889",{"name":74,"role":50,"phone":13,"phoneExt":13,"email":55},"İsmail Palalı, PT, PhD",{"facility":58,"status":13,"city":76,"state":60,"zip":61,"country":62,"countryCode":13,"cosmosGeoPoint":13,"geoPoint":13,"contacts":77},"Şanliurfa",[78],{"name":79,"role":50,"phone":72,"phoneExt":13,"email":52},"MEHMET İNCEBIYIK",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Mehmet Incebıyik","Assistant Professor, MD","100640549",false,"NCT07575490","Impact of Post-Cesarean Abdomino-Pelvic Training on Diastasis Recti and Sexual Function","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","APPT-S","Inclusion Criteria:Primiparous women (first-time mothers).\n\nWomen who have undergone an elective cesarean section.\n\nParticipants who are at their 6th week postpartum at the start of the study.\n\nAged between 18 and 45 years.\n\nVolunteering to participate and capable of signing the informed consent form.\n\n\\-\n\nExclusion Criteria:\n\n* Multiparous women (those with more than one delivery).\n\nWomen with a history of previous abdominal or pelvic surgery (other than the current C-section).\n\nPresence of chronic diseases (e.g., uncontrolled diabetes, hypertension, or connective tissue disorders).\n\nAny musculoskeletal or neurological condition that prevents participation in an exercise program.\n\nHistory of pelvic organ prolapse or severe urinary incontinence prior to pregnancy.\n\nActive pelvic or abdominal infection.\n\nParticipants who have already started a structured postpartum exercise program elsewhere.",true,"FEMALE","18 Years","45 Years",{"count":96,"type":97},120,"ESTIMATED","INTERVENTIONAL",[100],"NA","This study aims to investigate the effects of a specific exercise program on physical recovery and sexual health in women who have had a cesarean section. Pregnancy and abdominal surgery can lead to a separation of the abdominal muscles, known as Diastasis Recti Abdominis (DRA), and may affect pelvic health and sexual function. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in a 6-week \"Structured Abdomino-Pelvic Power-Training\" program starting at the 6th week after surgery. This program includes specific exercises to strengthen the core and pelvic floor muscles. The control group will follow the standard routine postpartum care. The researchers will use ultrasound and Doppler imaging to measure the distance between the abdominal muscles and the blood flow in the pelvic area at the beginning of the study and after 6 weeks of training. Participants will also complete a validated questionnaire (FSFI) to evaluate their sexual function. The goal of the research is to determine if this structured exercise program helps close the abdominal gap more effectively and improves pelvic blood flow and sexual well-being compared to standard care.",[103],"Diastasis Recti Abdominis Postpartum Period Cesarean Section Sexual Dysfunction, Physiological Pelvic Floor Muscle Training",[105,106,107,108,109,110,111],"Vaginal Doppler","Pelvic Hemodynamics","Abdomino-pelvic Training","FSFI (Female Sexual Function Index)","Post-cesarean Recovery","Core Stabilization","Uterine Artery Doppler","NOT_YET_RECRUITING","2026-05-02",{"date":115,"type":116},"2026-05-08","ACTUAL",{"date":118,"type":97},"2026-05",{"date":120,"type":97},"2026-12",{"name":5,"class":6},2]