Core Strengthening for DRA in Postpartum Women

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT03595696
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.5
• Patients Per Site Per Month: 5.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diastasis Recti; Postpartum; Low Back Pain	Other: Core Muscle Strength Training	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of a Core Strengthening Program on Diastasis Rectus Abdominus in Postpartum Women
• Actual Study Start Date: Oct 1, 2018
• Actual Primary Completion Date: Jul 16, 2019
• Actual Study Completion Date: Jul 16, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in inter-recti distance (IRD) [Up to 24 weeks]

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

Secondary Outcome Measures

1. Abdominal wall muscle function [Up to 24 weeks]

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

2. Low back pain [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 [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 [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 [Up to 24 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	11361

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT03595696
• Other Study ID Numbers: 2017-1999
• First Posted: Jul 23, 2018
• Last Update Posted: Nov 20, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Low Back Pain

Study Results

No Results Posted as of Nov 20, 2019