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.
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
- Conditions the study is for
- Diastasis Recti and Weakness of the Linea Alba
- 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.
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 group | Role | What they receive |
|---|---|---|
| Generalized Exercise | Active comparator | 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. Receives: Other: Exercise |
| Diastasis Specific Exercise | Experimental | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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.
- First posted8 Aug 2019
- Study start14 Oct 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Why it stopped: Covid
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.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Y Stone, University of Missouri-Columbia
- Investigators
- Jennifer Y Stone, DPT, Principal investigator, University of Missouri Health Care
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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Exercise in a Group Setting Compared to General Group Fitness Class: Impact on Diastasis Recti in Postpartum Women
- ClinicalTrials.gov ID
- NCT04049487
- Acronym / sponsor ID
- 2016673
- Keywords
- postpartum, diastasis recti, diastasis rectus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 8 Aug 2019 (actual)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Generalized Exercise | Active comparator | Other: ExerciseGeneral 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. |
| Diastasis Specific Exercise | Experimental | Other: ExerciseDiastasis 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Cardiovascular problems precluding exercise
- Exercise-induced asthma
- History of stroke
- History of abdominal surgery other than a cesarean section
- Current pregnancy
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 |
|---|---|---|
| ExerciseBoth groups will participate in group exercise as previously described | Other | Diastasis Specific Exercise, Generalized Exercise |
Primary outcome
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
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
3 secondary outcomes
Back pain comparison
Time frame: 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
Dyspareunia comparison
Time frame: At enrollment (prior to intervention), within 1 week following end of intervention
Results and safety
The study was stopped early (reason given: Covid). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No. Only the person who is doing data input will have access to IPD.
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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.
Jennifer Y Stone, DPT principal investigator
University of Missouri Health Care
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 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.