Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04049487 |
| Other study ID # |
2016673 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 14, 2019 |
| Est. completion date |
May 1, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
University of Missouri-Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
