Core Strengthening for DRA in Postpartum Women

NCT03595696 | Completed

• 1 other identifier: 2017-1999
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastasis Recti; Postpartum; Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in inter-recti distance (IRD)

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

  Up to 24 weeks

Secondary Outcomes (5)

• Abdominal wall muscle function

  Up to 24 weeks

• Low back pain

  Up to 24 weeks

• Pelvic function

  Up to 24 weeks

• Stress urinary incontinence

  Up to 24 weeks

• Body image

  Up to 24 weeks

Study Arms (2)

Core Strengthening Exercise Intervention

EXPERIMENTAL

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

Control+Core Strengthening Exercise

ACTIVE COMPARATOR

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

Interventions

Core Muscle Strength Training 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; Core Strengthening Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 11361, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ellen Casey, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: October 1, 2018
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

US (1)