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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04960800
• Other study ID #: 101944102
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: December 2023

Study information

• Verified date: July 2021
• Source: University of Bergen
• Contact: Nina- Margrethe Theodorsen, MSc
• Phone: 004792483509
• Email: nina-margrethe.theodorsen[@]uib.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Exclusion criteria during the study period is stillbirth or premature birth before gestation week 37; onset of serious illnesses regarding both mother and foetus; and pregnancies where exercise is contraindicated

Related Conditions & MeSH terms

• Diastasis Recti Abdominis
• Diastasis, Muscle
• Pregnancy Related

Intervention

Other:
• Specific 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.

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be change in inter-rectus distance in mm, measured by two-dimensional ultrasonography.	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.	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.