Diastasis Recti AbdominisNCT04122924
Postpartum Exercise and Diastasis Recti Abdominis
A study testing Abdominal muscle training in people with Diastasis Recti Abdominis and Diastasis Recti, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
Prevalence rates of diastasis recti abdominis (DRA) among postpartum women vary between 30% - 68%. It has been postulated that DRA, in addition to being a cosmetic concern for many women, may reduce low- back and pelvic stability causing low back- and pelvic girdle pain and be related to pelvic floor dysfunctions such… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diastasis Recti Abdominis, Diastasis Recti
- What is being tested?
- Abdominal muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- 9 Jan 2020to 21 Dec 2022
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primi- and multiparous women 6-12 months postpartum
- Understand instructions given in Norwegian language
- Willing/available to participate in a 3 months intervention period
Who cannot join
- Pregnant women
- Women < 6 months or > 12 months postpartum
- Women with children with illnesses and mothers with neurological, systemic musculoskeletal diseases or psychiatric diagnoses will be excluded from participation
- Women with adherence < 70 % of the home-based program will be excluded for the per protocol analyzes
- Women with specific need for pelvic floor muscle training during the 3 months intervention period will be excluded
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian School of Sport Sciences, Department of Sports Medicine
Oslo, 0863
About this study
Official title: Effect of Abdominal Muscle Training on Inter-recti Distance and Prevalence of Diastasis Recti Abdominis in Postpartum Primi- and Multiparous Women: A Randomized Controlled Trial
Prevalence rates of diastasis recti abdominis (DRA) among postpartum women vary between 30% - 68%. It has been postulated that DRA, in addition to being a cosmetic concern for many women, may reduce low- back and pelvic stability causing low back- and pelvic girdle pain and be related to pelvic floor dysfunctions such as urinary incontinence, anal incontinence and pelvic organ prolapse. Given the limited research data, there is currently no consensus on which abdominal exercises to recommend to narrow the diastasis.
The purpose of this assessor blinded parallel group randomized controlled trial (RCT) is to evaluate the effect of abdominal muscle training on inter-recti distance (IRD) and prevalence of DRA.
Read the detailed description
BACKGROUND:
DRA is defined as an impairment with midline separation of the two rectus abdominis muscles along the linea alba. The condition affects a significant number of women during the antenatal- and postnatal period. Today there is a strong focus on the pregnant woman's appearance, especially through social media. Webpages and apps recommend how women should stay thin and get back into shape with "a flat tummy" at an early stage of the postpartum period. There are easily available advices on how to get rid of what is named "the mum's belly" (e.g.mammamage.se, breakingmuscle.com, befitmom.com, babybellybelt.com, tummyzip.com). A systematic review of the scientific literature has found none or very weak evidence behind any of these advices. DRA is diagnosed by measuring the distance between the median borders of the two rectus abdominis; IRD, and ultrasound has been found to have the best intra- and inter-tester reliability with Intraclass Correlation Coefficient (ICC) > 0.9.
In a systematic review by Benjamin et al. (2014), 8 studies in treatment of DRA using abdominal exercises were found: four case studies, two retrospective observational studies, one quasi-experimental post-test study and one small RCT of a brief training intervention. A new search on Pubmed of July 2019 found six additional RCTs using abdominal exercises in treatment of DRA. The studies differ in methodological and interventional quality and results differ between studies. Given the limited research data, use of different outcome measures and cut-off point for diastasis in published studies, there is currently no consensus on which abdominal exercises to recommend to narrow the diastasis.
AIMS:
The aim of this study is to assess the effect of abdominal muscle training on IRD and prevalence of DRA in postpartum primi- and multiparous women.
STUDY DESIGN AND METHODS:
Before starting this RCT, an experimental cross-sectional study investigating the acute effect of different abdominal- and pelvic floor exercises on IRD in women with DRA will be conducted. Based on findings from the experimental cross-sectional study, we will choose exercises that narrow the IRD for the RCT's exercise program.
Women will respond to an electronic questionnaire sent by email before they meet for the clinical assessments, before and after the intervention period. Women diagnosed with DRA giving informed consent are assessed at baseline with 2D ultrasound measurements of IRD, abdominal muscle strength tests and the Oswestry Low Back Disability Index (ODI), Pelvic Girdle Questionnaire (PGQ) and (Pelvic Floor Disability Index) PFDI-20. After baseline testing the participants are randomly allocated to either an exercise or control group. Randomization will be computer-generated, in blocks of 4 with concealed allocation. Randomization will be provided by a person not involved in assessments of outcome. The outcome assessor will be blinded for group allocation. After the 3 month training period, both the exercise and control group will be reassessed with 2D ultrasound, abdominal muscle strength and endurance tests and the ODI, PGQ and PFDI-20.
- Conditions
- Diastasis Recti Abdominis, Diastasis Recti
- Being tested
- Abdominal muscle training
- Keywords
- Postpartum, Abdominal Muscle Training, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal muscle trainingOther
The intervention starts 6-12 months postpartum and will last for three months with weekly follow-up through an exercise app. Before commencing the home-based program, women in the intervention group will have an individual session in how to perform the program with a physiotherapist. The intervention consists of a 10 min 5 days a week exercise program, including the following exercises; headlift, crunch and twisted crunch. General principles for strength training are followed: 3 sets of 8-12 contractions close to maximum. The participants will be provided with a smartphone app (Athlete Monitoring) to be reminded to exercise and to register adherence.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | A three months home-based abdominal muscle training program. Receives: Other: Abdominal muscle training |
| Control Group | No intervention | The control group will have no intervention, and will be asked not to attend any specific supervised abdominal muscle training program during the 3 months intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IRD assessed by 2D ultrasonography
A portable 2D ultrasound (GE Healthcare -Logiq e R7) will be used to assess IRD inn mm at 2 cm above and 2 cm below (P. G. Mota et al., 2015a) the umbilicus during rest and crunch.
Measured: Change from baseline IRD at 3 months
Secondary outcomes (7)
Change in abdominal endurance
Abdominal endurance will be assessed as number of repetitions of one standardized abdominal crunch to exhaustion (ACSM, 2006).
Measured: Change from baseline abdominal endurance at 3 months
Change in abdominal strength
Maximal abdominal strength will be measured in a trunk dynamometer (HUMAC NORM).
Measured: Change from baseline abdominal strength at 3 months
Change in cross-sectional area of m. rectus abdominis
Cross-sectional area of m. rectus abdominis will be measured by 2D ultrasonography, above and below the umbilicus.
Measured: Change from baseline cross-sectional area at 3 months
Change in symptoms of low back pain
The electronic questionnaires include the following instrument: Oswestry Low Back Disability Index (ODI).
Measured: Change from baseline symptoms of low back pain at 3 months
Change in symptoms of pelvic girdle pain
The electronic questionnaire include the following instrument: Pelvic Girdle Questionnaire (PGQ).
Measured: Change from baseline symptoms of pelvic girdle pain at 3 months
Change in symptoms of pelvic floor dysfunctions
The electronic questionnaire include the following instrument: Pelvic Floor Disability Index (PFDI-20).
Measured: Change from baseline symptoms of pelvic floor dysfunctions at 3 months
Global rating of change (GRC)
Perceived change of the condition will be assessed by a numerical 11-point scale. A 11-point scale with response choices ranging from "completely recovered" to "very much worse".
Measured: Post-test after a 3-months intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start9 Jan 2020
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Diastasis Recti AbdominisStudies 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
- Model description
- An assessor blinded parallel group RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association
- Responsible party
- Principal investigator, Kari Bø, Norwegian School of Sport Sciences
- Investigators
- Kari Bø, PhD, Study chair, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122924
- Sponsor's protocol ID
- SLG89
- Status last verified
- Mar 2023
- First submitted
- 4 Oct 2019
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rett, M. T., Braga, M., Bernardes, N., & Andrade, S. (2009). Prevalence of diastasis of the rectus abdominis muscles immediately postpartum: comparison between primiparae and multiparae. Revista Brasileira De Fisioterapia, 13(4), 275-280. doi:10.1590/s1413-35552009005000037
Turan V, Colluoglu C, Turkyilmaz E, Korucuoglu U. Prevalence of diastasis recti abdominis in the population of young multiparous adults in Turkey. Ginekol Pol. 2011 Nov;82(11):817-21.
PubMed 22384613Lee DG, Lee LJ, McLaughlin L. Stability, continence and breathing: the role of fascia following pregnancy and delivery. J Bodyw Mov Ther. 2008 Oct;12(4):333-48. doi: 10.1016/j.jbmt.2008.05.003. Epub 2008 Jul 1.
PubMed 19083692Spitznagle TM, Leong FC, Van Dillen LR. Prevalence of diastasis recti abdominis in a urogynecological patient population. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):321-8. doi: 10.1007/s00192-006-0143-5. Epub 2006 Jul 26.
PubMed 16868659Venes, D., & Taber, C. (2013). Taber's cyclopedic medical dictionary (22. ed.). Philadelphia: FA Davis Co
Benjamin DR, van de Water AT, Peiris CL. Effects of exercise on diastasis of the rectus abdominis muscle in the antenatal and postnatal periods: a systematic review. Physiotherapy. 2014 Mar;100(1):1-8. doi: 10.1016/j.physio.2013.08.005. Epub 2013 Oct 5.
PubMed 24268942Mota P, Pascoal AG, Sancho F, Bo K. Test-retest and intrarater reliability of 2-dimensional ultrasound measurements of distance between rectus abdominis in women. J Orthop Sports Phys Ther. 2012 Nov;42(11):940-6. doi: 10.2519/jospt.2012.4115. Epub 2012 Jul 18.
PubMed 22810966Mesquita, L. A., Machado, A. V., & Andrade, A. V. (1999). Physiotherapy for reduction of diastasis of the recti adbominis muscles in the postpartum period. Rev Brasil Ginecol Obstet 21, 267-272.
Emanuelsson P, Gunnarsson U, Dahlstrand U, Strigard K, Stark B. Operative correction of abdominal rectus diastasis (ARD) reduces pain and improves abdominal wall muscle strength: A randomized, prospective trial comparing retromuscular mesh repair to double-row, self-retaining sutures. Surgery. 2016 Nov;160(5):1367-1375. doi: 10.1016/j.surg.2016.05.035. Epub 2016 Jul 27.
PubMed 27475817Gluppe SL, Hilde G, Tennfjord MK, Engh ME, Bo K. Effect of a Postpartum Training Program on the Prevalence of Diastasis Recti Abdominis in Postpartum Primiparous Women: A Randomized Controlled Trial. Phys Ther. 2018 Apr 1;98(4):260-268. doi: 10.1093/ptj/pzy008.
PubMed 29351646Kamel DM, Yousif AM. Neuromuscular Electrical Stimulation and Strength Recovery of Postnatal Diastasis Recti Abdominis Muscles. Ann Rehabil Med. 2017 Jun;41(3):465-474. doi: 10.5535/arm.2017.41.3.465. Epub 2017 Jun 29.
PubMed 28758085Tuttle, L. J., Fasching, J., Keller, A., Patel, M., Saville, C., Schlaff, R., . . . Gombatto, S. P. (2018). Noninvasive Treatment of Postpartum Diastasis Recti Abdominis: A Pilot Study. Journal of Women's Health Physical Therapy, 42(2), 65-75. doi:10.1097/jwh.0000000000000101
Walton, L. M., Costa, A., LaVanture, D., McIlrath, S., & Stebbins, B. (2016). The effects of a 6 week dynamic core stability plank exercise program compared to a traditional supine core stability strengthening program on diastasis recti abdominis closure, pain, oswestry disability index (ODI) and pelvic floor disability index scores (PFDI). Physical Therapy and Rehabilitation, 3(1), 3. doi:10.7243/2055-2386-3-3
Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.
PubMed 30839304Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A; American College of Sports Medicine; American Heart Association. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1081-93. doi: 10.1161/CIRCULATIONAHA.107.185649. Epub 2007 Aug 1.
PubMed 17671237
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Muscle Training on Inter-recti Distance and Prevalence of Diastasis Recti Abdominis in Postpartum Primi- and Multiparous Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04122924
- Acronym / sponsor ID
- SLG89
- Conditions
- Diastasis Recti Abdominis, Diastasis Recti
- Keywords
- Postpartum, Abdominal Muscle Training, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 10 Oct 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.
Prevalence rates of diastasis recti abdominis (DRA) among postpartum women vary between 30% - 68%. It has been postulated that DRA, in addition to being a cosmetic concern for many women, may reduce low- back and pelvic stability causing low back- and pelvic girdle pain and be related to pelvic floor dysfunctions such as urinary incontinence, anal incontinence and pelvic organ prolapse. Given the limited research data, there is currently no consensus on which abdominal exercises to recommend to narrow the diastasis.
The purpose of this assessor blinded parallel group randomized controlled trial (RCT) is to evaluate the effect of abdominal muscle training on inter-recti distance (IRD) and prevalence of DRA.
Detailed description
BACKGROUND:
DRA is defined as an impairment with midline separation of the two rectus abdominis muscles along the linea alba. The condition affects a significant number of women during the antenatal- and postnatal period. Today there is a strong focus on the pregnant woman's appearance, especially through social media. Webpages and apps recommend how women should stay thin and get back into shape with "a flat tummy" at an early stage of the postpartum period. There are easily available advices on how to get rid of what is named "the mum's belly" (e.g.mammamage.se, breakingmuscle.com, befitmom.com, babybellybelt.com, tummyzip.com). A systematic review of the scientific literature has found none or very weak evidence behind any of these advices. DRA is diagnosed by measuring the distance between the median borders of the two rectus abdominis; IRD, and ultrasound has been found to have the best intra- and inter-tester reliability with Intraclass Correlation Coefficient (ICC) > 0.9.
In a systematic review by Benjamin et al. (2014), 8 studies in treatment of DRA using abdominal exercises were found: four case studies, two retrospective observational studies, one quasi-experimental post-test study and one small RCT of a brief training intervention. A new search on Pubmed of July 2019 found six additional RCTs using abdominal exercises in treatment of DRA. The studies differ in methodological and interventional quality and results differ between studies. Given the limited research data, use of different outcome measures and cut-off point for diastasis in published studies, there is currently no consensus on which abdominal exercises to recommend to narrow the diastasis.
AIMS:
The aim of this study is to assess the effect of abdominal muscle training on IRD and prevalence of DRA in postpartum primi- and multiparous women.
STUDY DESIGN AND METHODS:
Before starting this RCT, an experimental cross-sectional study investigating the acute effect of different abdominal- and pelvic floor exercises on IRD in women with DRA will be conducted. Based on findings from the experimental cross-sectional study, we will choose exercises that narrow the IRD for the RCT's exercise program.
Women will respond to an electronic questionnaire sent by email before they meet for the clinical assessments, before and after the intervention period. Women diagnosed with DRA giving informed consent are assessed at baseline with 2D ultrasound measurements of IRD, abdominal muscle strength tests and the Oswestry Low Back Disability Index (ODI), Pelvic Girdle Questionnaire (PGQ) and (Pelvic Floor Disability Index) PFDI-20. After baseline testing the participants are randomly allocated to either an exercise or control group. Randomization will be computer-generated, in blocks of 4 with concealed allocation. Randomization will be provided by a person not involved in assessments of outcome. The outcome assessor will be blinded for group allocation. After the 3 month training period, both the exercise and control group will be reassessed with 2D ultrasound, abdominal muscle strength and endurance tests and the ODI, PGQ and PFDI-20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An assessor blinded parallel group RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Abdominal muscle trainingA three months home-based abdominal muscle training program. |
| Control Group | No intervention | –The control group will have no intervention, and will be asked not to attend any specific supervised abdominal muscle training program during the 3 months intervention period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primi- and multiparous women 6-12 months postpartum
- Understand instructions given in Norwegian language
- Willing/available to participate in a 3 months intervention period
Key exclusion criteria (5 listed)
- Pregnant women
- Women < 6 months or > 12 months postpartum
- Women with children with illnesses and mothers with neurological, systemic musculoskeletal diseases or psychiatric diagnoses will be excluded from participation
- Women with adherence < 70 % of the home-based program will be excluded for the per protocol analyzes
- Women with specific need for pelvic floor muscle training during the 3 months intervention period will be excluded
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 |
|---|---|---|
| Abdominal muscle trainingThe intervention starts 6-12 months postpartum and will last for three months with weekly follow-up through an exercise app. Before commencing the home-based program, women in the intervention group will have an individual session in how to perform the program with a physiotherapist. The intervention consists of a 10 min 5 days a week exercise program, including the following exercises; headlift, crunch and twisted crunch. General principles for strength training are followed: 3 sets of 8-12 contractions close to maximum. The participants will be provided with a smartphone app (Athlete Monitoring) to be reminded to exercise and to register adherence. | Other | Intervention Group |
Primary outcome
Change in IRD assessed by 2D ultrasonography
Time frame: Change from baseline IRD at 3 months
A portable 2D ultrasound (GE Healthcare -Logiq e R7) will be used to assess IRD inn mm at 2 cm above and 2 cm below (P. G. Mota et al., 2015a) the umbilicus during rest and crunch.
7 secondary outcomes
Change in abdominal endurance
Time frame: Change from baseline abdominal endurance at 3 months
Change in abdominal strength
Time frame: Change from baseline abdominal strength at 3 months
Change in cross-sectional area of m. rectus abdominis
Time frame: Change from baseline cross-sectional area at 3 months
Change in symptoms of low back pain
Time frame: Change from baseline symptoms of low back pain at 3 months
Change in symptoms of pelvic girdle pain
Time frame: Change from baseline symptoms of pelvic girdle pain at 3 months
Change in symptoms of pelvic floor dysfunctions
Time frame: Change from baseline symptoms of pelvic floor dysfunctions at 3 months
Global rating of change (GRC)
Time frame: Post-test after a 3-months intervention period
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 2 Mar 2023.
- BackgroundRett, M. T., Braga, M., Bernardes, N., & Andrade, S. (2009). Prevalence of diastasis of the rectus abdominis muscles immediately postpartum: comparison between primiparae and multiparae. Revista Brasileira De Fisioterapia, 13(4), 275-280. doi:10.1590/s1413-35552009005000037
- Background: PubMed 22384613Turan V, Colluoglu C, Turkyilmaz E, Korucuoglu U. Prevalence of diastasis recti abdominis in the population of young multiparous adults in Turkey. Ginekol Pol. 2011 Nov;82(11):817-21.
- Background: PubMed 19083692Lee DG, Lee LJ, McLaughlin L. Stability, continence and breathing: the role of fascia following pregnancy and delivery. J Bodyw Mov Ther. 2008 Oct;12(4):333-48. doi: 10.1016/j.jbmt.2008.05.003. Epub 2008 Jul 1.
- Background: PubMed 16868659Spitznagle TM, Leong FC, Van Dillen LR. Prevalence of diastasis recti abdominis in a urogynecological patient population. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):321-8. doi: 10.1007/s00192-006-0143-5. Epub 2006 Jul 26.
- BackgroundVenes, D., & Taber, C. (2013). Taber's cyclopedic medical dictionary (22. ed.). Philadelphia: FA Davis Co
- Background: PubMed 24268942Benjamin DR, van de Water AT, Peiris CL. Effects of exercise on diastasis of the rectus abdominis muscle in the antenatal and postnatal periods: a systematic review. Physiotherapy. 2014 Mar;100(1):1-8. doi: 10.1016/j.physio.2013.08.005. Epub 2013 Oct 5.
- Background: PubMed 22810966Mota P, Pascoal AG, Sancho F, Bo K. Test-retest and intrarater reliability of 2-dimensional ultrasound measurements of distance between rectus abdominis in women. J Orthop Sports Phys Ther. 2012 Nov;42(11):940-6. doi: 10.2519/jospt.2012.4115. Epub 2012 Jul 18.
- BackgroundMesquita, L. A., Machado, A. V., & Andrade, A. V. (1999). Physiotherapy for reduction of diastasis of the recti adbominis muscles in the postpartum period. Rev Brasil Ginecol Obstet 21, 267-272.
- Background: PubMed 27475817Emanuelsson P, Gunnarsson U, Dahlstrand U, Strigard K, Stark B. Operative correction of abdominal rectus diastasis (ARD) reduces pain and improves abdominal wall muscle strength: A randomized, prospective trial comparing retromuscular mesh repair to double-row, self-retaining sutures. Surgery. 2016 Nov;160(5):1367-1375. doi: 10.1016/j.surg.2016.05.035. Epub 2016 Jul 27.
- Background: PubMed 29351646Gluppe SL, Hilde G, Tennfjord MK, Engh ME, Bo K. Effect of a Postpartum Training Program on the Prevalence of Diastasis Recti Abdominis in Postpartum Primiparous Women: A Randomized Controlled Trial. Phys Ther. 2018 Apr 1;98(4):260-268. doi: 10.1093/ptj/pzy008.
- Background: PubMed 28758085Kamel DM, Yousif AM. Neuromuscular Electrical Stimulation and Strength Recovery of Postnatal Diastasis Recti Abdominis Muscles. Ann Rehabil Med. 2017 Jun;41(3):465-474. doi: 10.5535/arm.2017.41.3.465. Epub 2017 Jun 29.
- BackgroundTuttle, L. J., Fasching, J., Keller, A., Patel, M., Saville, C., Schlaff, R., . . . Gombatto, S. P. (2018). Noninvasive Treatment of Postpartum Diastasis Recti Abdominis: A Pilot Study. Journal of Women's Health Physical Therapy, 42(2), 65-75. doi:10.1097/jwh.0000000000000101
- 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.
Kari Bø, PhD study chair
Norwegian School of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal muscle training in people with Diastasis Recti Abdominis and Diastasis Recti, run by Norwegian School of Sport Sciences at 1 site in Norway.
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: finished, as of the sponsor's last update on 2 Mar 2023. 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 Norway. 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 IRD assessed by 2D ultrasonography (time frame: Change from baseline IRD at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122924, which also lists 21 linked publications.
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 2 Mar 2023.