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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03595696
Other study ID # 2017-1999
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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