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Core Strengthening for DRA in Postpartum Women

Primary Purpose

Diastasis Recti, Postpartum, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Core Muscle Strength Training
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diastasis Recti

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Core Strengthening Exercise Intervention

Control+Core Strengthening Exercise

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in inter-recti distance (IRD)
Change in IRD will be measured using palpation and musculoskeletal ultrasound.

Secondary Outcome Measures

Abdominal wall muscle function
Measured using musculoskeletal ultrasound at rest and during contraction (abdominal draw-in maneuver).
Low back pain
Measured using the Quebec Back Pain Disability Scale. Scores range from 0 to 100, with 100 representing higher disability.
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.
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.
Body image
Measured using the Body Shape Questionnaire. Scores range from 16 to 96, with a higher score representing impairment.

Full Information

First Posted
July 11, 2018
Last Updated
November 18, 2019
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT03595696
Brief Title
Core Strengthening for DRA in Postpartum Women
Official Title
Effect of a Core Strengthening Program on Diastasis Rectus Abdominus in Postpartum Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastasis Recti, Postpartum, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Core Strengthening Exercise Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control+Core Strengthening Exercise
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Core Muscle Strength Training
Intervention Description
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 Outcome Measure Information:
Title
Change in inter-recti distance (IRD)
Description
Change in IRD will be measured using palpation and musculoskeletal ultrasound.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Abdominal wall muscle function
Description
Measured using musculoskeletal ultrasound at rest and during contraction (abdominal draw-in maneuver).
Time Frame
Up to 24 weeks
Title
Low back pain
Description
Measured using the Quebec Back Pain Disability Scale. Scores range from 0 to 100, with 100 representing higher disability.
Time Frame
Up to 24 weeks
Title
Pelvic function
Description
Measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function. Scores range from 0 to 48, with a higher score representing greater impairment.
Time Frame
Up to 24 weeks
Title
Stress urinary incontinence
Description
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.
Time Frame
Up to 24 weeks
Title
Body image
Description
Measured using the Body Shape Questionnaire. Scores range from 16 to 96, with a higher score representing impairment.
Time Frame
Up to 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Casey, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
11361
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Core Strengthening for DRA in Postpartum Women

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