Core Strengthening for DRA in Postpartum Women

Not Applicable

Completed

• Conditions: Diastasis Recti; Low Back Pain; Postpartum

• Registration Number: NCT03595696
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

This study will prospectively measure the effectiveness of a core strengthening program on reducing the inter-rectus distance (IRD) and abdominal wall muscle contraction in postpartum women with diastasis rectus abdominus (DRA). Additionally, this study will aim to investigate and clarify the association between IRD and low back pain.

Detailed Description

DRA is a separation of the abdominal wall muscles that commonly occurs during pregnancy and is caused by the stretching of the linea alba to accommodate a growing fetus. Separation of core muscles is thought to be factor in postpartum low back pain, stress urinary incontinence, and core strength, as well as being cosmetically undesirable. This study will evaluate the effect of a core strengthening program on shortening the IRD and improving the connectivity and strength of abdominal wall muscles in postpartum women with a DRA. It will also investigate the relationship between IRD and low back pain.

Study Timeline

• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-23
• Study Start: 2018-10-01
• Primary Completion: 2019-07-16
• Study Completion: 2019-07-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• Healthy women who have given birth within the last 36 months but are at least 12 weeks postpartum
• Not currently pregnant
• Current DRA diagnosed using ultrasound with an IRD of at least 2.0 cm

Exclusion Criteria

• History of ventral/umbilical hernia prior to pregnancy
• >36 months postpartum
• Currently pregnant
• Beighton's score >5/9
• Unable to participate in a regular core strengthening program
• Unable to attend the three data collection sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in inter-recti distance (IRD)	Up to 24 weeks	Change in IRD will be measured using palpation and musculoskeletal ultrasound.

Secondary Outcome Measures

Name	Time	Method
Stress urinary incontinence	Up to 24 weeks	Measured using the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form. Scores range from 0 to 21, with higher scores indicating increased severity.
Abdominal wall muscle function	Up to 24 weeks	Measured using musculoskeletal ultrasound at rest and during contraction (abdominal draw-in maneuver).
Body image	Up to 24 weeks	Measured using the Body Shape Questionnaire. Scores range from 16 to 96, with a higher score representing impairment.
Low back pain	Up to 24 weeks	Measured using the Quebec Back Pain Disability Scale. Scores range from 0 to 100, with 100 representing higher disability.
Pelvic function	Up to 24 weeks	Measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function. Scores range from 0 to 48, with a higher score representing greater impairment.

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States