Postpartum Exercise and Diastasis Recti Abdominis

Study Overview
=================
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.

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

Conditions
-----------------
Diastasis Recti Abdominis, Diastasis Recti

Intervention / Treatment
-----------------
* Other: Abdominal muscle training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An assessor blinded parallel group RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>A three months home-based abdominal muscle training program. | Other: Abdominal muscle training<br>* 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.<br>|
| No Intervention: Control Group<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline IRD at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal endurance | Abdominal endurance will be assessed as number of repetitions of one standardized abdominal crunch to exhaustion (ACSM, 2006). | Change from baseline abdominal endurance at 3 months | 
| Change in abdominal strength | Maximal abdominal strength will be measured in a trunk dynamometer (HUMAC NORM). | 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. | 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). | 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). | 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). | 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. | Post-test after a 3-months intervention period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum, Abdominal Muscle Training, Exercise