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

NCT04960800 | Unknown

• 1 other identifier: 101944102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastasis Recti Abdominis; Pregnancy Related

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Intervention group

EXPERIMENTAL

The participants in the intervention group will participate in a 12- week specific exercise programme led by an experienced women's health physiotherapist. These groups will take place at a private physiotherapy clinic twice a week. In addition, the participants will carry out a self-managed exercise program twice weekly for the same 12-week period. They will be provided with an exercise diary so that adherence to the intervention can be registered and monitored. This exercise diary will be sent to the participants once a week as an electronic questionnaire; this will ensure that the information recorded is standardized and that the research assistant can aid the participants to register their activity and encourage the participants to adhere to the intervention.

Other: Specific exercises

Control group

NO INTERVENTION

The control group will not participate in any exercise intervention. The participants in the control group will be explained the importance of a control group in RCTs and will be recommended to continue with their normal activity levels. They will however, be recommended to follow national guidelines for general exercise during pregnancy and will receive information about these guidelines (15).

Interventions

Specific exercises OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy pregnant women
• in gestation week 25
• Both primi- and multigravida women will be included, and there will be no limitations on number of fetuses

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator

Study Sites (1)

University of Bergen

Bergen, 5009, Norway

Location

Related Publications (2)

• Theodorsen NM, Bo K, Fersum KV, Haukenes I, Moe-Nilssen R. Pregnant women may exercise both abdominal and pelvic floor muscles during pregnancy without increasing the diastasis recti abdominis: a randomised trial. J Physiother. 2024 Apr;70(2):142-148. doi: 10.1016/j.jphys.2024.02.002. Epub 2024 Mar 11.

  PMID: 38472049 DERIVED

• Theodorsen NM, Fersum KV, Moe-Nilssen R, Bo K, Haukenes I. Effect of a specific exercise programme during pregnancy on diastasis recti abdominis: study protocol for a randomised controlled trial. BMJ Open. 2022 Feb 4;12(2):e056558. doi: 10.1136/bmjopen-2021-056558.

  PMID: 35121606 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Inger Haukenes, PhD

  University of Bergen

  STUDY DIRECTOR

Central Study Contacts

Nina- Margrethe Theodorsen, MSc

CONTACT

004792483509; nina-margrethe.theodorsen@uib.no

Inger Haukenes, PhD

CONTACT

inger.haukenes@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 14, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)