Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras
Pátrai, Achaia, 26504, Greece
Location status: Recruiting
Location contact
Anastasia Skoura, PhD
CONTACT
Katerina Afroditi Chalki, BSc
SUB_INVESTIGATOR
NCT Number: NCT07389993
Diastasis Recti Abdominis (DRA) is a common condition experienced postpartum, in which the abdominal muscles separate along the midline of the abdomen due to stretching and thinning of the linea alba. It's a common condition, affecting 66-100% of women post-birth and may be associated with changes in abdominal support, posture, breathing, and trunk function. Although DRA primarily affects the muscles of the abdominal wall, it is speculated that other muscles controlling and stabilizing the trunk, such as the pelvic floor muscles or the diaphragm, might be affected as well. Currently, several studies have investigated the possible negative effects of DRA on pelvic floor function. However, little is known about how it may be related to diaphragm function and accessory breathing muscles.
The purpose of this observational study is to compare diaphragm characteristics and function, and accessory breathing muscle strength in women who have given birth, with and without DRA.
To make this possible, adult parous women from the broader Achaia region are assessed and allocated into two predefined groups based on the presence or absence of DRA. Participants undergo a single assessment session including rehabilitative ultrasound imaging (RUSI) of the diaphragm and standardized tests of inspiratory muscle strength. Additional demographic and clinical information related to pregnancy and physical activity is also recorded. The main hypothesis of this study is that women with DRA demonstrate altered diaphragm function, as well as reduced inspiratory muscle strength, compared to women without DRA. The study aims to improve understanding of the possible relationship between DRA and breathing function after childbirth and to support future research and rehabilitation approaches for women with the condition.
Interested in participating?
Request Info18 year–50 year
Female
Observational
Pátrai, Achaia, 26504, Greece
Location status: Recruiting
Anastasia Skoura, PhD
CONTACT
Katerina Afroditi Chalki, BSc
SUB_INVESTIGATOR
Diastasis recti abdominis (DRA) is a common postpartum condition, characterized by stretching and thinning of the linea alba and separation of the two rectus abdominis muscles along the midline of the abdomen. Beyond cosmetic concerns, DRA has been associated with impaired abdominal wall function, altered trunk stability, and potential changes in respiratory mechanics due to the close anatomical and functional relationship between the abdominal muscles and the diaphragm.
The diaphragm plays a central role in respiration and trunk stabilization, working synergistically with the abdominal wall to regulate intra-abdominal pressure (IAP) and postural control. Alterations in abdominal wall integrity, such as those observed in DRA, may therefore influence diaphragm function and mobility, as well as overall respiratory muscle performance. However, evidence regarding the relationship between DRA and diaphragm function currently remains limited.
This observational, cross-sectional study aims to examine diaphragm characteristics and inspiratory muscle strength in parous women with and without DRA. Participants are allocated into two predefined groups according to the presence or absence of DRA, based on a standardized imaging assessment.
Diaphragm function is assessed using rehabilitative ultrasound imaging (RUSI) techniques, performed by a trained physiotherapist, following standardized procedures. Ultrasound images are obtained during specific breathing maneuvers to determine diaphragm thickness and excursion. Inspiratory muscle strength is assessed using a standardized procedure to test maximal inspiratory pressure (MIP), S-Index and Peak Inspiratory Pressure (PIF) using a POWERbreathe KH2 device. All measurements are conducted during a single assessment session, and are led by three experienced physiotherapists. Furthermore, demographic data and relevant obstetric and clinical characteristics, such as age, body mass index (BMI), parity, and time since last delivery, are recorded to describe the study population.
The study aims to explore whether women with DRA demonstrate differences in diaphragm-related parameters and inspiratory muscle strength compared with women without DRA. By improving understanding of the interaction between the abdominal wall and respiratory muscles after childbirth, this research may contribute to the development of more targeted assessment strategies and rehabilitation approaches in postpartum care.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rehabilitative ultrasound imaging (RUSI) to assess diaphragm thickness and excursion under specific respiratory maneuvers.
A standardized inspiratory muscle strength testing procedure using a POWERbreathe KH2 device to assess maximal inspiratory pressure (MIP), S-Index and peak inspiratory flow (PIF).
Time frame: Baseline
Diaphragm thickness measured via ultrasound in cm at the end of a full inspiration at a standardized anatomical location.
Time frame: Baseline
Diaphragm thickness measured via ultrasound in cm at the end of a full expiration at a standardized anatomical location.
Time frame: Baseline
Diaphragm excursion measured via ultrasound in cm during quiet respiration at 60% of inspiratory capacity (IC).
Time frame: Baseline
Maximal Inspiratory Pressure (MIP) measured during a forceful inspiratory effort in cmΗ2Ο, using the POWERbreathe KH2 device.
Time frame: Baseline
S-Index, a strength estimate measured in cmH2O during a forceful inspiration performed using the POWERbreathe KH2 device.
Time frame: Baseline
Peak Inspiratory Flow (PIF) measured in L/sec, during the same forceful inspiratory maneuver as SIndex, using the POWERbreathe KH2 device.
Contact information is provided by the study sponsor or research team.
Anastasia Skoura, PhD
CONTACT
Evdokia Billis, PhD
CONTACT
University of Patras
Other
Diaphragm Characteristics and Respiratory Muscle Function in Parous Women With and Without Diastasis Recti Abdominis
Acronym: DRA-BREATH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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