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Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis

Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis: Study Protocol for a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04960800
Enrollment
100
Registered
2021-07-14
Start date
2021-09-30
Completion date
2023-12-31
Last updated
2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastasis Recti Abdominis, Pregnancy Related

Keywords

pregnancy, ultrasonography, exercise, diastasis recti abdominis, inter-recti distance

Brief summary

Diastasis Rectus abdominis is a common condition in pregnant and postpartum women, where the connective tissue between the two muscle bellies of the rectus abdominis muscle is stretched and weakened, causing an increased inter-rectus distance. Treatment of this condition aim to reduce the inter-rectus distance, and conservative treatment including therapeutic exercise is the primary treatment of choice. To date, there is no generally accepted protocol of therapeutic exercises for this condition, and the evidence as to which exercise modality is the most effective and feasible in reducing the inter-rectus distance in women presenting with diastasis rectus abdominis is both sparse and weak. As this condition occur during the last two trimesters of pregnancy and as there is a paucity of high-quality studies on a pregnant population, investigators will conduct a randomized controlled trial on the effect of a specific exercise program during pregnancy on diastasis rectus abdominis. 100 pregnant women in gestation week 25 presenting with diastasis rectus abdominis of ≥ 28 mm will be included. Participants will be allocated to either an intervention group or a control group by block randomization. The intervention group will participate in a 12-week specific exercise program, consisting of two group sessions and two self-managed sessions weekly. The control group will not participate in any exercise intervention; however, participants will be recommended to follow national guidelines for general exercise during pregnancy. Participants will be assessed prior to intervention, post intervention at gestation week 37, and 6 weeks, 6 and 12 months postpartum. The primary outcome measure will be change in the inter-rectus distance in mm, measured by two-dimensional ultrasonography.

Interventions

OTHERSpecific exercises

Specific exercises which aims to contract the recti abdominis combined with functional exercises with the aim to contract all the layers of the anterior abdominal wall. Strengthening dosage will be applied with 3 sets, containing between 8 and 12 repetitions of maximal load.

Sponsors

Norwegian Fund for Postgraduate Training in Physiotherapy
CollaboratorOTHER
University of Bergen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

To ensure randomization to the two groups in the RCT, participants will, following baseline assessments, be allocated to the two groups by block randomization. Blocking will be masked and not stated in the protocol to avoid selection bias. The group allocation will be administrated by a research assistant, to ensure blinding of the assessor. This study is assessor blinded only, as participants and the physiotherapist running the intervention groups cannot be blinded.

Intervention model description

This will be an exploratory, assessor blinded, randomized, controlled, parallel group trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* healthy pregnant women * in gestation week 25 * presenting with an inter-rectus distance of 28 mm or more at the level of the umbilicus, and/or 2 cm above and below the umbilicus at rest on initial assessment. Participants presenting with a protrusion along the Linea Alba will also be included, even if they do not meet the inclusion criteria with an inter-rectus distance of 28 mm or more * Both primi- and multigravida women will be included, and there will be no limitations on number of fetuses

Exclusion criteria

* pregnancies where exercise is contraindicated * serious illnesses regarding both mother and fetus * inability to understand Scandinavian languages * failure to complete and present an informed consent form * presence of chronic physical or mental illness incompatible with the intervention

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome measure will be change in inter-rectus distance in mm, measured by two-dimensional ultrasonography.All participants will be assessed prior to intervention start in gestation week 27. They will then be reassessed at end of the intervention period at gestation week 37. Assessments will also be done 6 weeks, 6 and 12 months postpartum.The inter-rectus distance is the distance between the two muscle bulks of the rectus abdominis muscle. As the two muscle bulks are connected through the connective tissue Linea Alba, the inter-rectus distance is equivalent to the width of the line alba.The inter-rectus distance is measured 2 cm above and 2 cm below the umbilicus. Images of the inter-rectus distance is taken using 2-dimensional ultrasound, and measured using the free Microdicom software. Measurements will be done in mm.

Countries

Norway

Contacts

Primary ContactNina- Margrethe Theodorsen, MSc
nina-margrethe.theodorsen@uib.no004792483509
Backup ContactInger Haukenes, PhD
inger.haukenes@uib.no

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026