- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04049487
Impact of Exercise on Diastasis Rectus Abdominus
Targeted Exercise in a Group Setting Compared to General Group Fitness Class: Impact on Diastasis Recti in Postpartum Women
Study Overview
Status
Intervention / Treatment
Detailed Description
Diastasis recti, is a condition where the linea alba becomes stretched, sometimes lax, and creates distance between the rectus abdominis muscle bellies. It occurs most often during and after pregnancy, abdominal weight gain, and sometimes due to straining while performing heavy lifting. If the linea alba becomes thin enough to tear, the person may experience a hernia. Inter-rectus distance >25mm (~2 finger widths) at one or more locations is considered to be clinically significant for diastasis recti. Pathological diastasis recti is an inter rectus distance widening more than 10mm (~1 finger width) above the umbilicus, 27mm (~2.5 finger widths) at the umbilicus, and 9mm (~1 finger width) below the umbilicus. Normal width of the linea alba in nulliparous women should be less than 15mm at the xiphoid process, 22 mm at 3cm above the umbilicus, and 16mm at 2 cm below umbilicus.
The prevalence of diastasis recti is significant in the postpartum population. Clinically significant diastasis recti is currently thought to be best assessed at 2cm above the umbilicus and 5cm above the umbilicus between 25-41 weeks of pregnancy, and at 6 months postpartum. At 6 months postpartum, the average values for diastasis recti using these measurements were 23mm average at 2cm above the umbilicus (~2.5 finger widths), and 18mm average at 5cm above the umbilicus (~2 finger widths). The measures below the umbilicus were clinically insignificant at 6 months postpartum.
Thed abdominal drawing-in maneuver (transverse abdominis activation) and curl up (rectus abdominis activation) are both exercise maneuvers that have been traditionally taught for diastasis resolution. It was found that curl ups alone narrow the inter-rectus distance but don't achieve tension through the linea alba. Transverse abdominis activation alone tensions the linea alba but doesn't achieve narrowing of the inter-rectus distance. Combined transverse abdominis activation and curl up achieves both narrowing and tension through the linea alba.
The positive correlation between diastasis recti and lumbopelvic pain, incontinence, and pelvic organ prolapse has been shown in recent studies as well. 52% of urogynecological patients had a diastasis recti in one study, and that 66% of those women had a support-related pelvic floor dysfunction (i.e. stress urinary incontinence (UI), fecal incontinence (FI), and/or pelvic organ prolapse (POP)). 45% of women in pregnancy have pelvic girdle pain (PGP), and 25% in the early postpartum period still have PGP. 5-7% of women continue to experience PGP at 12 wks postpartum. 45% of women have urinary incontinence at 7 years postpartum; 27% of those who were initially incontinent in the early postpartum period regained continence, but 31% who were initially continent became incontinent by 7 years postpartum, thus highlighting the need for early intervention of postpartum rehab.
In recent years, research on diastasis recti has become more prevalent. However, the research on diastasis recti recovery and physical therapy treatment programs is limited. Most of the studies thus far have looked at transverse abdominis activation, curl ups, and planks. Effects of strengthening abdominal obliques, hips, pelvic floor, and heavier strengthening of the rectus abdominis done at the same time have not yet been included in these studies.
The aim with this research project is to evaluate the success of diastasis recti closure after a 4-week group exercise class that includes: strengthening of each abdominal muscle group, hip strengthening and stabilization, and pelvic floor activation and cueing during exercises. Success will be evaluated by measuring width and depth of linea alba laxity before and after completion of the 4 sessions as well as other outcome measures such as lumbopelvic pain, pain with intercourse, and incontinence. Intervention will be compared to a control group that participates in an exercise program geared toward general health and wellness.
The goal is to evaluate whether a program incorporating hip, core, and pelvic floor strengthening specifically designed to address the weaknesses common in individuals with diastasis recti is superior to a generalized wellness program in addressing lumbopelvic pain, incontinence, and other pelvic health conditions. If so, this will lay the foundation for a protocol to guide the clinician on safe, yet effective, methods of core strengthening so women are able to transition back into community fitness classes safely and without fear of worsening their diastasis recti.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
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Columbia, Missouri, United States, 65202
- MU Healthcare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18 and 60
- Has had a vaginal or cesarean delivery between 12 weeks and 2 years ago
- Has a diastasis measured at least 2 cm wide
Exclusion Criteria:
- Cardiovascular problems precluding exercise
- Exercise-induced asthma
- History of stroke
- History of abdominal surgery other than a cesarean section
- Current pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Generalized Exercise
General wellness/exercise program designed to replicate a generic wellness program that one would find in a gym setting.
Will be led by an exercise instructor.
|
Both groups will participate in group exercise as previously described
|
|
Experimental: Diastasis Specific Exercise
Diastasis specific exercise program incorporating multiple muscle groups and based on research findings of exercises that are shown to be effective for reducing size and impact of diastasis rectus.
|
Both groups will participate in group exercise as previously described
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diastasis width comparison
Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention
|
Measured by the same outcomes assessor, reported in centimeters
|
At enrollment (prior to intervention), within 1 week following end of intervention
|
|
Diastasis depth comparison
Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention
|
Measured by the same outcomes assessor, reported in centimeters
|
At enrollment (prior to intervention), within 1 week following end of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Back pain comparison
Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention
|
Measured using the Numeric Pain Rating scale.
This scale measures pain on a spectrum from 0 (no pain) to 10 (worst pain you can imagine) and is validated for use in comparison within an individual.
|
At enrollment (prior to intervention), within 1 week following end of intervention
|
|
Incontinence comparison
Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention
|
Measured by presence or absence, frequency of leaking, need for pads
|
At enrollment (prior to intervention), within 1 week following end of intervention
|
|
Dyspareunia comparison
Time Frame: At enrollment (prior to intervention), within 1 week following end of intervention
|
Using the Marinoff Dyspareunia Scale Score.
This scale measures level of dyspareunia (pain with sex) on a spectrum from 0 (no limitations to sex) to 3 (unable to participate in penetrative intercourse due to pain).
|
At enrollment (prior to intervention), within 1 week following end of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Y Stone, DPT, University of Missouri Health Care
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016673
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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