Core Strengthening for DRA in Postpartum Women

Effect of a Core Strengthening Program on Diastasis Rectus Abdominus 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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Postpartum; Diastasis Recti
• Intervention / Treatment: Other: Core Muscle Strength Training

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11361
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Core Strengthening Exercise Intervention; All subjects will participate in the study for a total of 24 consecutive weeks. During the first 12 weeks, subjects will participate in weekly online exercise classes for Core Muscle Strength training and will be asked to perform daily homework assignments. Following completion of the 12-week intervention, subjects will be asked to continue the exercises on their own.	Other: Core Muscle Strength Training; 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.
ACTIVE_COMPARATOR: Control+Core Strengthening Exercise; All subjects will participate in the study for a total of 24 weeks. During the first 12 weeks, subjects will serve as the control group, and they will be advised to continue their baseline level of exercise and lifestyle. During the subsequent 12 weeks, subjects will participate in the exact same program as Group A performed during the first 12 weeks (Core Muscle Strength Training).	Other: Core Muscle Strength Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inter-recti distance (IRD)	Change in IRD will be measured using palpation and musculoskeletal ultrasound.	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal wall muscle function	Measured using musculoskeletal ultrasound at rest and during contraction (abdominal draw-in maneuver).	Up to 24 weeks
Low back pain	Measured using the Quebec Back Pain Disability Scale. Scores range from 0 to 100, with 100 representing higher disability.	Up to 24 weeks
Pelvic function	Measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function. Scores range from 0 to 48, with a higher score representing greater impairment.	Up to 24 weeks
Stress urinary incontinence	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.	Up to 24 weeks
Body image	Measured using the Body Shape Questionnaire. Scores range from 16 to 96, with a higher score representing impairment.	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Ellen Casey, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): July 16, 2019
• Study Completion (ACTUAL): July 16, 2019

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (ACTUAL): July 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2017-1999

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No