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Completed

NCT Number: NCT03595696

Core Strengthening for DRA in Postpartum Women

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.

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Key information

Conditions

Diastasis Recti Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Postpartum Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 11361, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Core Muscle Strength Training

Other

Targeted weekly workouts consisting of low-impact aerobic exercises and resistance exercises designed to address muscle imbalance common in women who exhibit DRA and to prompt automatic core engagement while performing compound, multi-joint movements.

Primary outcomes

  1. Change in inter-recti distance (IRD)

    Time frame: Up to 24 weeks

    Change in IRD will be measured using palpation and musculoskeletal ultrasound.

Secondary outcomes

  1. Abdominal wall muscle function

    Time frame: Up to 24 weeks

    Measured using musculoskeletal ultrasound at rest and during contraction (abdominal draw-in maneuver).

  2. Low back pain

    Time frame: Up to 24 weeks

    Measured using the Quebec Back Pain Disability Scale. Scores range from 0 to 100, with 100 representing higher disability.

  3. Pelvic function

    Time frame: 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.

  4. Stress urinary incontinence

    Time frame: 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.

  5. Body image

    Time frame: Up to 24 weeks

    Measured using the Body Shape Questionnaire. Scores range from 16 to 96, with a higher score representing impairment.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Effect of a Core Strengthening Program on Diastasis Rectus Abdominus in Postpartum Women

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2018
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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