Diastasis Recti And Weakness Of The Linea AlbaNCT02268110
The Effect of Conservative Interventions on the Signs and Symptoms of Diastasis Recti
A study testing Exercise therapy and Abdominal binding in people with Diastasis Recti And Weakness Of The Linea Alba, run by Queen's University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Diastasis Recti And Weakness Of The Linea Alba
- What is being tested?
- Exercise therapy and Abdominal binding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Exercise therapy, Abdominal binding
- Keywords
- diastasis recti, physiotherapy, exercise therapy, abdominal binding
- Medical subject headings
- Diastasis Recti And Weakness Of The Linea Alba
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyOther
Supervised exercise therapy with a 12 week progressive abdominal exercise home program for
Abdominal bindingOther
Wearing an abdominal binder for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise therapy | Experimental | Participants will receive 12 sessions with a physiotherapist where they will receive instructions on body mechanics, and be given a progressive abdominal exercise program Receives: Other: Exercise therapy |
| Abdominal binding | Experimental | Participants will be fitted for an abdominal binder and asked to wear it for a period of 12 weeks. Receives: Other: Abdominal binding |
| Exercise therapy and Abdominal Binding | Experimental | Participants will attend 12 sessions with a physiotherapist, and receive an abdominal binder Receives: Other: Exercise therapy; Other: Abdominal binding |
| Control | No intervention | Participants will not receive an intervention during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inter-Rectus Distance
Measured using ultrasound imaging
Measured: baseline, 12 weeks post intervention, 9 months post intervention
Secondary outcomes (6)
Change in Abdominal Strength and Endurance
measured using clinical tests and hand-held dynamometry
Measured: baseline, 12 weeks post intervention, 9 months post intervention
Change in Body image
measured using the Multidimensional Body-Self Relations Questionnaire
Measured: baseline, 12 weeks post intervention, 9 months post intervention
Change in Lumbopelvic dysfunction
measured using Modified Oswestry Questionnaire
Measured: baseline, 12 weeks post intervention, 9 months post intervention
Change in Urogynecological Complaints
measured using the Pelvic Floor Distress Inventory
Measured: baseline, 12 weeks post intervention, 9 months post intervention
Change in Severity of Lumbopelvic and/or Abdominal Pain
Visual Analog Scale
Measured: baseline, 12 weeks post intervention, 9 months post intervention
Change in Perceived Function
Inventory of Functional Status After Childbirth Questionnaire
Measured: baseline, 12 weeks post intervention, 9 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis Recti And Weakness Of The Linea AlbaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Nadia Keshwani, Queen's University
- Investigators
- McLean Linda, PhD, Study director, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268110
- Sponsor's protocol ID
- REH-566-13
- Status last verified
- Sep 2018
- First submitted
- 10 Oct 2014
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02268110
- Acronym / sponsor ID
- REH-566-13
- Keywords
- diastasis recti, physiotherapy, exercise therapy, abdominal binding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Aug 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise therapy | Experimental | Other: Exercise therapyParticipants will receive 12 sessions with a physiotherapist where they will receive instructions on body mechanics, and be given a progressive abdominal exercise program |
| Abdominal binding | Experimental | Other: Abdominal bindingParticipants will be fitted for an abdominal binder and asked to wear it for a period of 12 weeks. |
| Exercise therapy and Abdominal Binding | Experimental | Other: Exercise therapy, Other: Abdominal bindingParticipants will attend 12 sessions with a physiotherapist, and receive an abdominal binder |
| Control | No intervention | –Participants will not receive an intervention during the study period |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise therapySupervised exercise therapy with a 12 week progressive abdominal exercise home program for | Other | Exercise therapy and Abdominal Binding, Supervised exercise therapy |
| Abdominal bindingWearing an abdominal binder for 12 weeks | Other | Abdominal binding, Exercise therapy and Abdominal Binding |
Primary outcome
Change in Inter-Rectus Distance
Time frame: baseline, 12 weeks post intervention, 9 months post intervention
Measured using ultrasound imaging
6 secondary outcomes
Change in Abdominal Strength and Endurance
Time frame: baseline, 12 weeks post intervention, 9 months post intervention
Change in Body image
Time frame: baseline, 12 weeks post intervention, 9 months post intervention
Change in Lumbopelvic dysfunction
Time frame: baseline, 12 weeks post intervention, 9 months post intervention
Change in Urogynecological Complaints
Time frame: 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
Change in Perceived Function
Time frame: baseline, 12 weeks post intervention, 9 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
McLean Linda, PhD study director
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy and Abdominal binding in people with Diastasis Recti And Weakness Of The Linea Alba, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inter-Rectus Distance (time frame: baseline, 12 weeks post intervention, 9 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.