Diaphragm and Breathing Muscle Characteristics in Women With and Without Diastasis Recti Abdominis After Childbirth

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorUniversity of Patras

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female sex

Aged 18 to 50 years

Parous women (at least one previous childbirth)

At least 6 months postpartum at the time of assessment (and within 5 years postpartum)

Disqualifiers

Current pregnancy

Delivery within the previous 6 months

History of severe chronic respiratory disease (e.g., chronic obstructive pulmonary disease, chronic bronchitis, pulmonary emphysema, pulmonary fibrosis)

Presence of connective tissue disorders

Trial population

Parous adult women from the local community (broader Achaia region) recruited through invitations and referrals and assessed in a clinical research setting.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Ultrasonographic assessment of the diaphragm

    Diagnostic test

    Rehabilitative ultrasound imaging (RUSI) to assess diaphragm thickness and excursion under specific respiratory maneuvers.

  • Inspiratory muscle testing

    Diagnostic test

    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).

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Women with diastasis recti abdominis2 interventions
Group B: Women without diastasis recti abdominis2 interventions

Trial outcomes

Primary outcomes

1

Inspiratory diaphragm thickness

Diaphragm thickness measured via ultrasound in cm at the end of a full inspiration at a standardized anatomical location.

Time frame
Baseline
2

Expiratory diaphragm thickness

Diaphragm thickness measured via ultrasound in cm at the end of a full expiration at a standardized anatomical location.

Time frame
Baseline
3

Diaphragm excursion

Diaphragm excursion measured via ultrasound in cm during quiet respiration at 60% of inspiratory capacity (IC).

Time frame
Baseline

Secondary outcomes

1

Maximal Inspiratory Pressure (MIP)

Maximal Inspiratory Pressure (MIP) measured during a forceful inspiratory effort in cmΗ2Ο, using the POWERbreathe KH2 device.

Time frame
Baseline
2

S-Index

S-Index, a strength estimate measured in cmH2O during a forceful inspiration performed using the POWERbreathe KH2 device.

Time frame
Baseline
3

Peak Inspiratory Flow (PIF)

Peak Inspiratory Flow (PIF) measured in L/sec, during the same forceful inspiratory maneuver as SIndex, using the POWERbreathe KH2 device.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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