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Completed

NCT Number: NCT04122924

Postpartum Exercise and Diastasis Recti Abdominis

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian School of Sport Sciences, Department of Sports Medicine

Oslo, 0863, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal muscle training

Other

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.

Primary outcomes

  1. 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

  1. Change in abdominal endurance

    Time frame: Change from baseline abdominal endurance at 3 months

    Abdominal endurance will be assessed as number of repetitions of one standardized abdominal crunch to exhaustion (ACSM, 2006).

  2. Change in abdominal strength

    Time frame: Change from baseline abdominal strength at 3 months

    Maximal abdominal strength will be measured in a trunk dynamometer (HUMAC NORM).

  3. Change in cross-sectional area of m. rectus abdominis

    Time frame: Change from baseline cross-sectional area at 3 months

    Cross-sectional area of m. rectus abdominis will be measured by 2D ultrasonography, above and below the umbilicus.

  4. Change in symptoms of low back pain

    Time frame: Change from baseline symptoms of low back pain at 3 months

    The electronic questionnaires include the following instrument: Oswestry Low Back Disability Index (ODI).

  5. Change in symptoms of pelvic girdle pain

    Time frame: Change from baseline symptoms of pelvic girdle pain at 3 months

    The electronic questionnaire include the following instrument: Pelvic Girdle Questionnaire (PGQ).

  6. Change in symptoms of pelvic floor dysfunctions

    Time frame: Change from baseline symptoms of pelvic floor dysfunctions at 3 months

    The electronic questionnaire include the following instrument: Pelvic Floor Disability Index (PFDI-20).

  7. Global rating of change (GRC)

    Time frame: Post-test after a 3-months intervention period

    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".

Sponsors and collaborators

Lead sponsor

Norwegian School of Sport Sciences

Other

Collaborators

  • The Norwegian Women´s Public Health Association

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2019
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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