Core Strengthening for DRA in Postpartum Women

NCT ID: NCT03595696

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-07-16

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.

Conditions

Diastasis Recti; Postpartum; Low Back Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Core Muscle Strength Training

Intervention Type: OTHER

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.

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).

Group Type: ACTIVE_COMPARATOR

Core Muscle Strength Training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen Casey, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2017-1999

Identifier Type: -

Identifier Source: org_study_id