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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Exercise therapy
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.
Other: Abdominal binding
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
Other: Exercise therapy
Supervised exercise therapy with a 12 week progressive abdominal exercise home program for
Other: Abdominal binding
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen's University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REH-566-13

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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