RecruitingACTRN12621000613808

Investigating the effect of three contrasting interventions on recovery of abdominal muscle separation after childbirth

A feasibility randomised controlled trial of three contrasting interventions for recovery of persistant post-natal diastasis of the rectus abdominis muscle

Sponsor

Dr Tanja Miokovic

Enrollment

100 participants

Start Date

Jun 11, 2021

Study Type

Interventional

Conditions

Diastasis of the Rectus Abdominis Muscle

Summary

This aim of this pilot trial is to assess the best management approach to rehabilitation of postnatal Diastasis of the Rectus Abdominis Muscle (DRAM), commonly referred to as abdominal muscle separation, 100 first-time mothers will be recruited for this study. Participants with DRAM at 6-8 weeks postnatal will be allocated to one of three intervention groups: advice only; abdominal binder; back and abdominal muscle exercise. Ultrasound imaging will be used to collect images of the abdominal muscles for the linea alba distortion index (primary outcome measure) and inter-rectii distance. Additional outcome measures include- low back pain, pelvic girdle pain, stress urinary incontinence and body image. It is hypothesised that: 1) the linea alba tension rather than the inter-rectii distance will have more of an impact on functional outcomes of low back and pelvic girdle pain, body image and pelvic floor function; and 2) the exercise group will demonstrate significantly less linea alba distortion than the control or abdominal binder groups.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After giving birth for the first time, many women develop a condition called diastasis recti abdominis — a separation of the abdominal muscles along the midline of the belly. This is very common and can contribute to lower back pain, pelvic pain, and bladder leakage. This study is looking at the best way to help new mothers recover from this condition in the weeks after delivery. Researchers are comparing three different approaches: giving advice only, using an abdominal binder (a supportive wrap worn around the belly), or doing a targeted exercise program for the back and abdominal muscles. Ultrasound imaging will be used to measure the gap between the muscles and assess how the tissue is healing. The study will also track back pain, pelvic discomfort, and bladder control over time. You may be eligible if you are a first-time mother aged 18 or over, are within 2 weeks of giving birth, and had a vaginal delivery with no major complications. The study is looking for women who are willing to attend follow-up visits at the data collection site.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your Doctor Check Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Participants will be enrolled in the study prior to two weeks post-natal. The first baseline data (outcome measure) collection timepoint will take place at two weeks postnatal. Participants will be re-assessed at eight weeks post-natal and those that have persistent diastasis of the rectus abdominis muscle allocated to one of three groups for intervention (of 12 weeks duration): 1. Advice only 2. Abdominal support - these participants will be required to wear an abdominal support for 10-12 hours/day for 12 weeks. The abdominal support is an easily removable elasticised garment worn in a double layer extending from the pubic symphysis to the xiphoid process of the sternum. Instructions for wear and fitting will be provided by an experienced Women's Health Physiotherapist. Participants will be asked to complete a diary to monitor adherence to the intervention. 3. Abdominal exercise- these participants will be required to see a Physiotherapist for 7 sessions over 12 weeks for exercise prescription and progression and be asked to perform these exercises at home 5 times per week for 20 minutes. Exercises will commence with static activation of the transverses abdominis muscle in crook-lying, side-lying and 4-point-kneel position. These will be progressed to including arm and/or leg movements and further progressed to involve movement of the Thorax on the lumbar spine i.e. curl-up, Russian twist. Exercises are of a low-moderate intensity and will be performed until fatigue. This will be assessed via monitoring of posture, breathing and correct muscle activation patterns. Participants will be asked to complete an exercise diary to monitor adherence to the intervention. Outcome measures will be reassessed at the end of the intervention i.e. at 20 weeks post-natal, with the final outcome measure data collection to take place 3 months following the end of the intervention i.e. when participants are 32 weeks post-natal.

Locations(1)

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12621000613808