- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02268110
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
Completed
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Diastasis Recti And Weakness Of The Linea Alba
-
Swissmed HospitalMedical University of Gdansk; Śmietański Hernia CenterNot yet recruitingAbdominal Wall Defect | Postpartum Complication | Diastasis Recti and Weakness of the Linea Alba | Abdominal Wall Anomaly
-
University of ValenciaUniversity Hospital, CaenRecruitingDiastasis Recti | Diastasis Recti and Weakness of the Linea AlbaSpain
-
Marta CavalliRecruitingDiastasis Recti and Weakness of the Linea AlbaItaly
-
University of Missouri-ColumbiaTerminatedDiastasis Recti and Weakness of the Linea AlbaUnited States
-
University of Castilla-La ManchaNot yet recruitingDiastasis Recti | Diastasis Recti and Weakness of the Linea Alba | Diastasis Recti Abdominis | Diastasis
-
Atlas UniversityCompletedDiastasis Recti Abdominis | Diastasis Recti And Weakness Of The Linea AlbaTurkey
-
University of PatrasCompletedTelerehabilitation | Diastasis Recti | Diastasis Recti And Weakness Of The Linea Alba | Diastasis Recti Abdominis (DRA)Greece
-
Atlas UniversityCompletedDiastasis Recti | Diastasis Recti and Weakness of the Linea AlbaTurkey
-
University of PatrasRecruitingDiastasis, Muscle | Diastasis Recti And Weakness Of The Linea AlbaGreece
-
South Valley UniversityCompletedDiastasis Recti and Weakness of the Linea AlbaEgypt
Clinical Trials on Exercise therapy
-
University Hospital, GhentCompletedInsertional Achilles TendinopathyBelgium
-
Norwegian University of Science and TechnologyCompletedPatellofemoral Pain Syndrome
-
Istanbul Physical Medicine Rehabilitation Training...Completedthe Effect of Virtual Reality on Stroke Rehabilitation
-
Proaxis TherapyVirginia Commonwealth University; Arcadia University; National Athletic Trainers...CompletedShoulder Impingement SyndromeUnited States
-
Taipei Medical UniversityNot yet recruiting
-
Royal College of Surgeons, IrelandUnknownHip OsteoarthritisIreland
-
University Hospital, GhentCompletedAchilles TendinopathyBelgium
-
Gazi UniversityCompletedTemporomandibular DisorderTurkey
-
George Washington UniversityCompletedPrematurityUnited States
-
Medipol UniversityCompletedHemiplegia | Gait, Hemiplegic | Motor Function | Balance; DistortedTurkey