Core Strengthening for DRA in Postpartum Women

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595696
• Other study ID #: 2017-1999
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 16, 2019

Study information

• Verified date: November 2019
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Diastasis Recti
• Low Back Pain
• Postpartum

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inter-recti distance (IRD)	Change in IRD will be measured using palpation and musculoskeletal ultrasound.	Up to 24 weeks
Secondary	Abdominal wall muscle function	Measured using musculoskeletal ultrasound at rest and during contraction (abdominal draw-in maneuver).	Up to 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Body image	Measured using the Body Shape Questionnaire. Scores range from 16 to 96, with a higher score representing impairment.	Up to 24 weeks