Clinical trial NCT04122924: Postpartum Exercise and Diastasis Recti Abdominis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastasis Recti Abdominis
Diastasis Recti
Keywords: Postpartum
Abdominal Muscle Training
Exercise
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: The Norwegian Women´s Public Health Association
First posted: 2019-10-10
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An assessor blinded parallel group RCT
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Primi- and multiparous women 6-12 months postpartum
* Understand instructions given in Norwegian language
* Willing/available to participate in a 3 months intervention period

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in IRD assessed by 2D ultrasonography
timeFrame: Change from baseline IRD at 3 months
Secondary outcomes:
measure: Change in abdominal endurance
timeFrame: Change from baseline abdominal endurance at 3 months
measure: Change in abdominal strength
timeFrame: Change from baseline abdominal strength at 3 months
measure: Change in cross-sectional area of m. rectus abdominis
timeFrame: Change from baseline cross-sectional area at 3 months
measure: Change in symptoms of low back pain
timeFrame: Change from baseline symptoms of low back pain at 3 months
measure: Change in symptoms of pelvic girdle pain
timeFrame: Change from baseline symptoms of pelvic girdle pain at 3 months
measure: Change in symptoms of pelvic floor dysfunctions
timeFrame: Change from baseline symptoms of pelvic floor dysfunctions at 3 months
measure: Global rating of change (GRC)
timeFrame: Post-test after a 3-months intervention period
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sport Sciences, Department of Sports Medicine
Study officials:
affiliation: Norwegian School of Sport Sciences
name: Kari Bø, PhD
role: STUDY_CHAIR
References:
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