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Clinical Trials/NCT04122924
NCT04122924CompletedNot Applicable

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

Norwegian School of Sport Sciences2 sites in 1 country70 target enrollmentStarted: January 9, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
Change in IRD assessed by 2D ultrasonography

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in abdominal endurance(Change from baseline abdominal endurance at 3 months)
  • Change in abdominal strength(Change from baseline abdominal strength at 3 months)
  • Change in cross-sectional area of m. rectus abdominis(Change from baseline cross-sectional area at 3 months)
  • Change in symptoms of low back pain(Change from baseline symptoms of low back pain at 3 months)
  • Change in symptoms of pelvic girdle pain(Change from baseline symptoms of pelvic girdle pain at 3 months)
  • Change in symptoms of pelvic floor dysfunctions(Change from baseline symptoms of pelvic floor dysfunctions at 3 months)
  • Global rating of change (GRC)(Post-test after a 3-months intervention period)

Investigators

Sponsor
Norwegian School of Sport Sciences
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kari Bø

Prof, PhD, PT, Exercise scientist

Norwegian School of Sport Sciences

Study Sites (2)

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