protocolSection identificationModule nctId: NCT06286553, orgStudyIdInfo id: DRA Rehab TEG & IMT, briefTitle: Rehabilitation of Abdominal Diastasis After Childbirth: Trunk and Inspiratory Muscle Training, acronym: DR-TIME, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University of Patras, class: OTHER, descriptionModule briefSummary: Diastasis Recti Abdominis (DRA) is the separation of the rectus muscles caused by stretching and thinning of the linea alba during pregnancy and childbirth. It's a common condition, affecting 66-100% of women post-birth and can persist for many years, leading to abdominal protrusion, discomfort, and aesthetic concerns. It might also contribute to back pain, urinary issues, and reduced abdominal strength, impacting quality of life. Recent guidelines propose that conservative management, such as rehabilitation interventions, should be prioritized for DRA. However, there is a lack of consensus among researchers regarding the most effective exercise regimen, resulting in diverse rehabilitation programs. Recent evidence advocates not only for closing the gap but also for achieving optimal function. Current studies often neglect to address functional rehabilitation, underscoring the necessity for robust clinical trials, which is the primary focus of this study.Additionally, although breathing exercises are commonly prescribed for DRA, the precise role of the diaphragm, the primary respiratory muscle, in rehabilitation hasn't been fully examined. The diaphragm forms the upper boundary of the abdominal cavity and plays a key role in the stability of the trunk, working together with the abdominal and pelvic floor muscles. A recent study found reduced diaphragm excursion in postpartum women with lumbopelvic pain during a low postural demanding task, while previous studies suggest that diaphragm training could alleviate such symptoms influencing factors such as diaphragm thickness and excursion, which may be linked to improved trunk stability. Hence, training the diaphragm and accessory inspiratory muscles through Inspiratory Muscle Training (IMT) could potentially play a crucial role in managing DRA.In summary, the goal of this study is to develop and assess a comprehensive rehabilitation program aimed at effectively reducing DRA and addressing associated dysfunctions. The program will integrate evidence-based rehabilitation interventions, such as trunk stabilization exercises and IMT, targeting all related dysfunctions caused by DRA, and introducing a novel therapeutic protocol not previously implemented. The study will take the form of a prospective, randomized controlled trial (RCT)., conditionsModule conditions: Diastasis Recti And Weakness Of The Linea Alba, conditions: Diastasis, Muscle, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this interventional study, three distinct groups are included. The Trunk Exercise Group (TEG) will partake in a comprehensive 12-week therapeutic exercise program that involves progressive strengthening exercises specifically targeting the trunk and pelvic floor muscles, alongside functional retraining exercises. The Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG) will adhere to the same 12-week therapeutic exercise program as TEG, with additional exercises focusing on strengthening the inspiratory muscles using inspiratory resistance (IMT). The control group (CG) will not participate in the 12-week exercise program but will receive a single exercise session and general management information (oral and written) for DRA., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Trunk exercise, interventions name: Inspiratory Muscle Training (IMT), interventions name: Control Group, outcomesModule primaryOutcomes measure: Inter-recti distance (IRD), secondaryOutcomes measure: Diaphragmatic Thickness, secondaryOutcomes measure: Diaphragmatic Excursion, secondaryOutcomes measure: Maximum Inspiratory Pressure (MIP), secondaryOutcomes measure: Strength Index (S-Index), secondaryOutcomes measure: Peak Inspiratory Flow (PIF), secondaryOutcomes measure: Trunk flexion test, secondaryOutcomes measure: Plank test, secondaryOutcomes measure: Side plank test, secondaryOutcomes measure: McGill's trunk flexor endurance test, secondaryOutcomes measure: Body Image States Scale (BISS), secondaryOutcomes measure: Activities Assessment Scale (AAS), secondaryOutcomes measure: Hernia-Related Quality-of-Life Survey (HerQLes), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras, status: RECRUITING, city: Patras, state: Achaia, Greece, zip: 26504, country: Greece, contacts name: Evdokia Billis, PhD, role: CONTACT, phone: 00306973047170, email: billis@upatras.gr, contacts name: Anastasia Skoura, MSc, role: CONTACT, phone: 00306947784948, email: a.skoura@upatras.gr, geoPoint lat: 38.24444, lon: 21.73444, hasResults: False