The Effect of Conservative Interventions on the Signs and Symptoms of Diastasis Recti

September 24, 2018 updated by: Nadia Keshwani, Queen's University

The Effect of Exercise Therapy and/or Abdominal Binding on Inter-rectus Distance, Abdominal Muscle Strength, Lumbopelvic and Urogynecological Complaints, Perceived Function, and Body Image in Post-partum Women With Diastasis Recti

The purpose of this study is to determine the effect of two different physiotherapeutic interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of diastasis recti in post-partum women.

Study Overview

Detailed Description

This study is investigating the effect of exercise therapy and/or abdominal binding on inter-rectus distance, abdominal muscle strength and endurance, lumbopelvic dysfunction, urogynecological complaints, perceived function, and body image in post-partum women with diastasis recti

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada
        • Rehabilitation Sciences Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 to 35 years old
  • given birth to their first child, vaginally, in the last three to four weeks
  • inter-rectus distance of two finger widths of greater on palpation during head lift

Exclusion Criteria:

  • history of persistent pain with intercourse prior to pregnancy
  • diagnosed with neurological impairments affecting the central nervous system or sacral nerves
  • diagnosed with connective tissue disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised exercise therapy
Participants will receive 12 sessions with a physiotherapist where they will receive instructions on body mechanics, and be given a progressive abdominal exercise program
Supervised exercise therapy with a 12 week progressive abdominal exercise home program for
Experimental: Abdominal binding
Participants will be fitted for an abdominal binder and asked to wear it for a period of 12 weeks.
Wearing an abdominal binder for 12 weeks
Experimental: Exercise therapy and Abdominal Binding
Participants will attend 12 sessions with a physiotherapist, and receive an abdominal binder
Supervised exercise therapy with a 12 week progressive abdominal exercise home program for
Wearing an abdominal binder for 12 weeks
No Intervention: Control
Participants will not receive an intervention during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Inter-Rectus Distance
Time Frame: baseline, 12 weeks post intervention, 9 months post intervention
Measured using ultrasound imaging
baseline, 12 weeks post intervention, 9 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Abdominal Strength and Endurance
Time Frame: baseline, 12 weeks post intervention, 9 months post intervention
measured using clinical tests and hand-held dynamometry
baseline, 12 weeks post intervention, 9 months post intervention
Change in Body image
Time Frame: baseline, 12 weeks post intervention, 9 months post intervention
measured using the Multidimensional Body-Self Relations Questionnaire
baseline, 12 weeks post intervention, 9 months post intervention
Change in Lumbopelvic dysfunction
Time Frame: baseline, 12 weeks post intervention, 9 months post intervention
measured using Modified Oswestry Questionnaire
baseline, 12 weeks post intervention, 9 months post intervention
Change in Urogynecological Complaints
Time Frame: baseline, 12 weeks post intervention, 9 months post intervention
measured using the Pelvic Floor Distress Inventory
baseline, 12 weeks post intervention, 9 months post intervention
Change in Severity of Lumbopelvic and/or Abdominal Pain
Time Frame: baseline, 12 weeks post intervention, 9 months post intervention
Visual Analog Scale
baseline, 12 weeks post intervention, 9 months post intervention
Change in Perceived Function
Time Frame: baseline, 12 weeks post intervention, 9 months post intervention
Inventory of Functional Status After Childbirth Questionnaire
baseline, 12 weeks post intervention, 9 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: McLean Linda, PhD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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