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Diastasis Recti and Weakness of the Linea AlbaNCT04049487

Impact of Exercise on Diastasis Rectus Abdominus

A study testing Exercise in people with Diastasis Recti and Weakness of the Linea Alba, run by University of Missouri-Columbia at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
14 Oct 2019to 1 May 2020
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 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Cardiovascular problems precluding exercise
  • Exercise-induced asthma
  • History of stroke
  • History of abdominal surgery other than a cesarean section
  • Current pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • MU Healthcare

    Columbia, Missouri, 65202

Other trials in United States

About this study

Official title: Targeted Exercise in a Group Setting Compared to General Group Fitness Class: Impact on Diastasis Recti in Postpartum Women

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.

Read the 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.

Being tested
Exercise
Keywords
postpartum, diastasis recti, diastasis rectus
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.

  • ExerciseOther

    Both groups will participate in group exercise as previously described

Study groups in NCT04049487
Study groupRoleWhat they receive
Generalized ExerciseActive comparatorGeneral 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.
Receives: Other: Exercise
Diastasis Specific ExerciseExperimentalDiastasis 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.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diastasis width comparison

    Measured by the same outcomes assessor, reported in centimeters

    Measured: At enrollment (prior to intervention), within 1 week following end of intervention

  2. Diastasis depth comparison

    Measured by the same outcomes assessor, reported in centimeters

    Measured: At enrollment (prior to intervention), within 1 week following end of intervention

Secondary outcomes (3)
  1. Back pain comparison

    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.

    Measured: At enrollment (prior to intervention), within 1 week following end of intervention

  2. Incontinence comparison

    Measured by presence or absence, frequency of leaking, need for pads

    Measured: At enrollment (prior to intervention), within 1 week following end of intervention

  3. Dyspareunia comparison

    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).

    Measured: At enrollment (prior to intervention), within 1 week following end of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start14 Oct 2019
  3. Primary completion1 May 2020
  4. Study completion1 May 2020

Why it stopped: Covid

Resources

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
Model description
Participants will be matched and randomly assigned to two groups: a general exercise group and a diastasis specific group. Each group will participate in a 4 week long exercise program.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04049487
Sponsor's protocol ID
2016673
Status last verified
Dec 2020
First submitted
6 Aug 2019
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only the person who is doing data input will have access to IPD.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Diastasis Recti and Weakness of the Linea Alba, run by University of Missouri-Columbia at 1 site in United States.

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 5 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: stopped early, as of the sponsor's last update on 17 Dec 2020. 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 United States. 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 was stopped early (reason given: Covid). Results are not available in the source record.

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?

Diastasis width comparison (time frame: At enrollment (prior to intervention), within 1 week following end of intervention). The study lists 2 primary outcomes in all. 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 17 Dec 2020.

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